Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-27 @ 3:44 PM
Study NCT ID:
NCT01978912
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2013-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-safety@teijinpo.com', 'phone': '+1-212-308-8744', 'title': 'President', 'organization': 'Teijin America, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 month', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Myofascial 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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[{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'title': 'Participants with any AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Participants with any TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Participants with any serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Participants with any AESIs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to study discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Any clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results.\n\nAEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'title': 'Participants with abnormal changes in ECG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Participants without abnormal changes in ECG', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Participants with abnormal CLT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Participants without abnormal CL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'Assessment of the number of participants with change in 12-lead ECG and CLT were assessed from baseline, 24 hours and 13 weeks.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'categories': [{'title': 'BLQ during the study up to 13 weeks', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Not BLQ during the study up to 13 weeks', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'The serum concentrations of KTP-001 were below the limit of quantification (BLQ) (\\<100 ng/mL) at all time points in all participants', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-KTP-001 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'categories': [{'title': 'Negative during the study up to 13 weeks', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Positive during the study up to 13 weeks', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'title': 'Change in Current Low Back Pain at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '2.28', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '3.90', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '1.79', 'groupId': 'OG003'}]}]}, {'title': 'Change in Current Low Back Pain at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '4.18', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '2.28', 'groupId': 'OG003'}]}]}, {'title': 'Change in Low Back Average Daily Pain at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.64', 'spread': '3.587', 'groupId': 'OG000'}, {'value': '-3.97', 'spread': '2.448', 'groupId': 'OG001'}, {'value': '-3.36', 'spread': '2.674', 'groupId': 'OG002'}, {'value': '-3.84', 'spread': '2.551', 'groupId': 'OG003'}]}]}, {'title': 'Change in Low Back Average Daily Pain at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.27', 'spread': '2.919', 'groupId': 'OG000'}, {'value': '-4.36', 'spread': '2.787', 'groupId': 'OG001'}, {'value': '-2.17', 'spread': '3.572', 'groupId': 'OG002'}, {'value': '-4.30', 'spread': '1.669', 'groupId': 'OG003'}]}]}, {'title': 'Change in Low Back Worst Daily Pain at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.72', 'spread': '3.984', 'groupId': 'OG000'}, {'value': '-4.27', 'spread': '3.066', 'groupId': 'OG001'}, {'value': '-3.64', 'spread': '3.018', 'groupId': 'OG002'}, {'value': '-3.88', 'spread': '2.488', 'groupId': 'OG003'}]}]}, {'title': 'Change in Low Back Worst Daily Pain at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.90', 'spread': '2.928', 'groupId': 'OG000'}, {'value': '-4.96', 'spread': '3.303', 'groupId': 'OG001'}, {'value': '-2.43', 'spread': '3.829', 'groupId': 'OG002'}, {'value': '-2.90', 'spread': '1.089', 'groupId': 'OG003'}]}]}, {'title': 'Change in Current Leg Pain at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '3.96', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '2.70', 'groupId': 'OG003'}]}]}, {'title': 'Change in Current Leg Pain at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '3.87', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '3.13', 'groupId': 'OG003'}]}]}, {'title': 'Change in Leg Average Daily Pain at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.66', 'spread': '3.669', 'groupId': 'OG000'}, {'value': '-4.83', 'spread': '1.515', 'groupId': 'OG001'}, {'value': '-3.76', 'spread': '2.985', 'groupId': 'OG002'}, {'value': '-4.00', 'spread': '3.476', 'groupId': 'OG003'}]}]}, {'title': 'Change in Leg Average Daily Pain at Week13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.63', 'spread': '3.053', 'groupId': 'OG000'}, {'value': '-5.28', 'spread': '1.145', 'groupId': 'OG001'}, {'value': '-4.20', 'spread': '2.647', 'groupId': 'OG002'}, {'value': '-5.70', 'spread': '1.669', 'groupId': 'OG003'}]}]}, {'title': 'Change in Leg Worst Daily Pain at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.34', 'spread': '3.449', 'groupId': 'OG000'}, {'value': '-4.93', 'spread': '2.355', 'groupId': 'OG001'}, {'value': '-4.12', 'spread': '3.239', 'groupId': 'OG002'}, {'value': '-3.72', 'spread': '3.294', 'groupId': 'OG003'}]}]}, {'title': 'Change in Leg Worst Daily Pain at Week13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.30', 'spread': '3.074', 'groupId': 'OG000'}, {'value': '-5.60', 'spread': '2.159', 'groupId': 'OG001'}, {'value': '-4.23', 'spread': '2.986', 'groupId': 'OG002'}, {'value': '-5.40', 'spread': '1.275', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': 'Lower back and leg pain were assessed using an 11-point numerical rating scale (0 = "no pain" and 10 = "worst possible pain").\n\nThe endpoint was mean change from baseline at 6 and 13 weeks post-dose; with a negative number suggesting an improvement in pain while a positive number suggests a worsening in pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'title': 'Straight-Leg Raising Test at Week 6', 'categories': [{'title': 'Positive to Negative', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Negative to Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Straight-Leg Raising Test at Week 13', 'categories': [{'title': 'Positive to Negative', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Negative to Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Femoral Stretch Test at Week 6', 'categories': [{'title': 'Positive to Negative', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Negative to Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No change', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Femoral Stretch Test at Week 13', 'categories': [{'title': 'Positive to Negative', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Negative to Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No change', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': 'The changes to spinal flexion and tension were assessed using Straight-Leg Rising (SLR) and Femoral Stretch (FS) tests which are on a scale of no change, positive to negative or negative to positive and where a positive result for SLR may indicate between 30 and 70 degrees, where a positive result for FS may indicate pain in the anterior thigh of the test leg and the elicited pain.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Changes in the Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': '0-20 Minimal Disability', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '20-40 Moderate Disability', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': '40-60 Severe Disability', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': '60-80 Crippled', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '80-100 Bedbound', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'title': '0-20 Minimal Disability', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': '20-40 Moderate Disability', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '40-60 Severe Disability', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '60-80 Crippled', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '80-100 Bedbound', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 13', 'categories': [{'title': '0-20 Minimal Disability', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': '20-40 Moderate Disability', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': '40-60 Severe Disability', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '60-80 Crippled', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '80-100 Bedbound', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': 'The Oswestry Disability Index (ODI) score is calculated as participant score divided by possible score multiplied by 100, where the following scores can be interpreted to indicate:\n\n0-20% = Minimal disability; 20-40% = Moderate disability; 40-60% = Severe disability; 60-80% = Crippled; 80-100% = Bed bound;', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Quality of Life as Assessed by Short Form-12 (SF-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'title': 'Change in Physical Functioning score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.400', 'spread': '0.4183', 'groupId': 'OG000'}, {'value': '0.333', 'spread': '0.3028', 'groupId': 'OG001'}, {'value': '0.400', 'spread': '0.4183', 'groupId': 'OG002'}, {'value': '0.200', 'spread': '0.2092', 'groupId': 'OG003'}]}]}, {'title': 'Change in Physical Functioning score at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.208', 'spread': '0.2458', 'groupId': 'OG000'}, {'value': '0.500', 'spread': '0.3162', 'groupId': 'OG001'}, {'value': '0.333', 'spread': '0.5401', 'groupId': 'OG002'}, {'value': '0.250', 'spread': '0.2500', 'groupId': 'OG003'}]}]}, {'title': 'Change in Role Physical score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.2500', 'spread': '0.35355', 'groupId': 'OG000'}, {'value': '0.2292', 'spread': '0.27858', 'groupId': 'OG001'}, {'value': '0.3000', 'spread': '0.20917', 'groupId': 'OG002'}, {'value': '0.2250', 'spread': '0.31125', 'groupId': 'OG003'}]}]}, {'title': 'Change in Role Physical score at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1667', 'spread': '0.23274', 'groupId': 'OG000'}, {'value': '0.2083', 'spread': '0.32275', 'groupId': 'OG001'}, {'value': '0.3333', 'spread': '0.41583', 'groupId': 'OG002'}, {'value': '0.3750', 'spread': '0.15309', 'groupId': 'OG003'}]}]}, {'title': 'Change in Bodily Pain score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.100', 'spread': '0.3791', 'groupId': 'OG000'}, {'value': '-0.417', 'spread': '0.2041', 'groupId': 'OG001'}, {'value': '-0.300', 'spread': '0.2739', 'groupId': 'OG002'}, {'value': '-0.350', 'spread': '0.1369', 'groupId': 'OG003'}]}]}, {'title': 'Change in Bodily Pain score at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.167', 'spread': '0.3764', 'groupId': 'OG000'}, {'value': '-0.417', 'spread': '0.2041', 'groupId': 'OG001'}, {'value': '-0.333', 'spread': '0.3028', 'groupId': 'OG002'}, {'value': '-0.400', 'spread': '0.2850', 'groupId': 'OG003'}]}]}, {'title': 'Change in General Health score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '0.042', 'spread': '0.1021', 'groupId': 'OG001'}, {'value': '-0.100', 'spread': '0.1369', 'groupId': 'OG002'}, {'value': '-0.150', 'spread': '0.1369', 'groupId': 'OG003'}]}]}, {'title': 'Change in General Health score at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '-0.042', 'spread': '0.1021', 'groupId': 'OG001'}, {'value': '-0.167', 'spread': '0.1291', 'groupId': 'OG002'}, {'value': '-0.100', 'spread': '0.1369', 'groupId': 'OG003'}]}]}, {'title': 'Change in Vitality score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.100', 'spread': '0.2236', 'groupId': 'OG000'}, {'value': '-0.167', 'spread': '0.1291', 'groupId': 'OG001'}, {'value': '0.050', 'spread': '0.2092', 'groupId': 'OG002'}, {'value': '-0.250', 'spread': '0.2500', 'groupId': 'OG003'}]}]}, {'title': 'Change in Vitality score at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.3162', 'groupId': 'OG000'}, {'value': '-0.125', 'spread': '0.1369', 'groupId': 'OG001'}, {'value': '-0.042', 'spread': '0.2923', 'groupId': 'OG002'}, {'value': '-0.200', 'spread': '0.2739', 'groupId': 'OG003'}]}]}, {'title': 'Change in Social Functioning score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.100', 'spread': '0.2850', 'groupId': 'OG000'}, {'value': '0.292', 'spread': '0.2923', 'groupId': 'OG001'}, {'value': '0.250', 'spread': '0.2500', 'groupId': 'OG002'}, {'value': '0.300', 'spread': '0.2092', 'groupId': 'OG003'}]}]}, {'title': 'Change in Social Functioning score at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.125', 'spread': '0.2092', 'groupId': 'OG000'}, {'value': '0.333', 'spread': '0.3028', 'groupId': 'OG001'}, {'value': '0.333', 'spread': '0.3764', 'groupId': 'OG002'}, {'value': '0.400', 'spread': '0.2850', 'groupId': 'OG003'}]}]}, {'title': 'Change in Role Emotional score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1000', 'spread': '0.34686', 'groupId': 'OG000'}, {'value': '0.2292', 'spread': '0.25516', 'groupId': 'OG001'}, {'value': '0.2500', 'spread': '0.19764', 'groupId': 'OG002'}, {'value': '0.1750', 'spread': '0.31375', 'groupId': 'OG003'}]}]}, {'title': 'Change in Role Emotional score at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1875', 'spread': '0.27099', 'groupId': 'OG000'}, {'value': '0.3542', 'spread': '0.30017', 'groupId': 'OG001'}, {'value': '0.2083', 'spread': '0.20412', 'groupId': 'OG002'}, {'value': '0.2750', 'spread': '0.32355', 'groupId': 'OG003'}]}]}, {'title': 'Change in Mental Health score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.08839', 'groupId': 'OG000'}, {'value': '0.0625', 'spread': '0.06847', 'groupId': 'OG001'}, {'value': '0.0250', 'spread': '0.13693', 'groupId': 'OG002'}, {'value': '-0.0500', 'spread': '0.22707', 'groupId': 'OG003'}]}]}, {'title': 'Change in Mental Health score at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0417', 'spread': '0.06455', 'groupId': 'OG000'}, {'value': '0.1667', 'spread': '0.21890', 'groupId': 'OG001'}, {'value': '0.0208', 'spread': '0.14613', 'groupId': 'OG002'}, {'value': '0.0250', 'spread': '0.16298', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': "The endpoint was change from baseline at Week 6 and 13 hours post-dose. The Short Form-12 (SF-12) is a Quality of Life questionnaire which measures functional health and well-being from a participant's perspective across eight health domains. Each participant answers questions on a 5-point Likert scale, which rates responses according to how much the participant agrees or disagrees with a particular statement on their health and wellbeing, including vitality/physical functioning/bodily pain/general health perceptions/physical role functioning/emotional role functioning/social role functioning and mental health. Each scale is transformed into a 0-100 scale, assuming each question carries equal weight. Lower scores mean greater disability and higher scores mean less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Global Impression of Change (PGI-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '3.27', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '1.64', 'groupId': 'OG003'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '3.27', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '2.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': 'The Patient Global Impression Change PGI-C scale was used where the scale ranges are from 1 (no change or condition has got worse) to 7 (a great deal better, and a considerable improvement). The endpoint was the value at 6 and 13 weeks post-dose.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Serum Concentrations of Keratan Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'OG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-93.7', 'spread': '59.22', 'groupId': 'OG000'}, {'value': '-84.7', 'spread': '47.24', 'groupId': 'OG001'}, {'value': '-37.3', 'spread': '42.28', 'groupId': 'OG002'}, {'value': '-24.8', 'spread': '49.68', 'groupId': 'OG003'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-39.2', 'spread': '87.90', 'groupId': 'OG000'}, {'value': '-73.2', 'spread': '34.59', 'groupId': 'OG001'}, {'value': '35.2', 'spread': '72.37', 'groupId': 'OG002'}, {'value': '141.8', 'spread': '262.07', 'groupId': 'OG003'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77.3', 'spread': '30.66', 'groupId': 'OG000'}, {'value': '47.2', 'spread': '47.31', 'groupId': 'OG001'}, {'value': '117.7', 'spread': '41.31', 'groupId': 'OG002'}, {'value': '297.3', 'spread': '144.99', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.0', 'spread': '62.77', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '81.96', 'groupId': 'OG001'}, {'value': '102.0', 'spread': '69.13', 'groupId': 'OG002'}, {'value': '173.2', 'spread': '120.44', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.2', 'spread': '45.44', 'groupId': 'OG000'}, {'value': '-36.7', 'spread': '66.22', 'groupId': 'OG001'}, {'value': '87.2', 'spread': '49.60', 'groupId': 'OG002'}, {'value': '26.8', 'spread': '79.08', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '74.31', 'groupId': 'OG000'}, {'value': '-41.7', 'spread': '69.84', 'groupId': 'OG001'}, {'value': '64.0', 'spread': '61.46', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '81.86', 'groupId': 'OG003'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '127.30', 'groupId': 'OG000'}, {'value': '-39.2', 'spread': '63.90', 'groupId': 'OG001'}, {'value': '55.8', 'spread': '83.71', 'groupId': 'OG002'}, {'value': '-13.6', 'spread': '43.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 24 hours and 1, 2, 4, 6 weeks and 13 weeks post-dose', 'description': 'The endpoint was change from baseline at 6 and 24 hours post-dose, and at the 1-, 2-, 4-, 6-, and 13-week follow-up visits or early termination visit.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'FG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'FG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'FG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lumbar Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Intradiscal Steroid Injection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 KTP-001 5 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'BG001', 'title': 'Cohort 2 KTP-001 15 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'BG002', 'title': 'Cohort 3 KTP-001 50 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'BG003', 'title': 'Cohort 4 KTP-001 150 μg/Disc', 'description': 'KTP-001: KTP-001 is one time dose intradiscally.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '3.33', 'groupId': 'BG000'}, {'value': '49.0', 'spread': '8.90', 'groupId': 'BG001'}, {'value': '52.2', 'spread': '13.23', 'groupId': 'BG002'}, {'value': '47.0', 'spread': '9.49', 'groupId': 'BG003'}, {'value': '46.1', 'spread': '10.68', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-20', 'size': 1664938, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-26T04:53', 'hasProtocol': True}, {'date': '2018-05-03', 'size': 756824, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-26T04:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-02', 'studyFirstSubmitDate': '2013-10-22', 'resultsFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2013-11-01', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-30', 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': 'Lower back and leg pain were assessed using an 11-point numerical rating scale (0 = "no pain" and 10 = "worst possible pain").\n\nThe endpoint was mean change from baseline at 6 and 13 weeks post-dose; with a negative number suggesting an improvement in pain while a positive number suggests a worsening in pain.'}, {'measure': 'Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': 'The changes to spinal flexion and tension were assessed using Straight-Leg Rising (SLR) and Femoral Stretch (FS) tests which are on a scale of no change, positive to negative or negative to positive and where a positive result for SLR may indicate between 30 and 70 degrees, where a positive result for FS may indicate pain in the anterior thigh of the test leg and the elicited pain.'}, {'measure': 'Number of Participants With Changes in the Oswestry Disability Index', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': 'The Oswestry Disability Index (ODI) score is calculated as participant score divided by possible score multiplied by 100, where the following scores can be interpreted to indicate:\n\n0-20% = Minimal disability; 20-40% = Moderate disability; 40-60% = Severe disability; 60-80% = Crippled; 80-100% = Bed bound;'}, {'measure': 'Changes in Quality of Life as Assessed by Short Form-12 (SF-12)', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': "The endpoint was change from baseline at Week 6 and 13 hours post-dose. The Short Form-12 (SF-12) is a Quality of Life questionnaire which measures functional health and well-being from a participant's perspective across eight health domains. Each participant answers questions on a 5-point Likert scale, which rates responses according to how much the participant agrees or disagrees with a particular statement on their health and wellbeing, including vitality/physical functioning/bodily pain/general health perceptions/physical role functioning/emotional role functioning/social role functioning and mental health. Each scale is transformed into a 0-100 scale, assuming each question carries equal weight. Lower scores mean greater disability and higher scores mean less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."}, {'measure': 'Patient Global Impression of Change (PGI-C)', 'timeFrame': 'Baseline, 6 weeks and 13 weeks post-dose', 'description': 'The Patient Global Impression Change PGI-C scale was used where the scale ranges are from 1 (no change or condition has got worse) to 7 (a great deal better, and a considerable improvement). The endpoint was the value at 6 and 13 weeks post-dose.'}, {'measure': 'Changes in Serum Concentrations of Keratan Sulfate', 'timeFrame': 'Baseline, 6 and 24 hours and 1, 2, 4, 6 weeks and 13 weeks post-dose', 'description': 'The endpoint was change from baseline at 6 and 24 hours post-dose, and at the 1-, 2-, 4-, 6-, and 13-week follow-up visits or early termination visit.'}], 'primaryOutcomes': [{'measure': 'Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs', 'timeFrame': '24 months', 'description': 'Any clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results.\n\nAEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment.'}, {'measure': 'Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)', 'timeFrame': '13 weeks', 'description': 'Assessment of the number of participants with change in 12-lead ECG and CLT were assessed from baseline, 24 hours and 13 weeks.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ)', 'timeFrame': '13 weeks', 'description': 'The serum concentrations of KTP-001 were below the limit of quantification (BLQ) (\\<100 ng/mL) at all time points in all participants'}, {'measure': 'Number of Participants With Anti-KTP-001 Antibody', 'timeFrame': '13 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.', 'detailedDescription': 'This study was a first-in-human, open-label, non-controlled single ascending dose study of KTP-001 in male and female subjects between the ages of 30 and 70 years with a single herniated lumbar disc. After obtaining informed consent, subjects were evaluated during a screening period of no more than 3 weeks (21 days). This study was conducted in 10 centers in the US.\n\nSubjects that met all screening requirements and inclusion criteria and none of the exclusion criteria were enrolled into the study. Overall, 24 subjects were enrolled and treated: 6 subjects in each cohort. Cohort 1 received a 5 μg/disc dose of KTP-001 by intradiscal injection. Following administration of study drug, subjects were confined to the study center for 24 hours to collect data for safety and efficacy measures and collect blood samples for safety, PK evaluation, exploratory PD and anti-KTP-001 antibody and then returned for further assessments at various intervals from weeks 1 through to month 24.\n\nAfter all subjects in Cohort 1 had received study drug, safety measures were evaluated by a Data and Safety Monitoring Board (DSMB) to determine whether to escalate KTP-001 administration to the next dose level. If appropriate, Cohort 2 subjects received 15 μg/disc of KTP-001, Cohort 3 subjects received 50 μg/disc of KTP-001, and Cohort 4 subjects received 150 μg/disc of KTP-001 by intradiscal injection. All safety, PK, and exploratory efficacy assessments were performed for the subjects in the subsequent cohorts as were performed for Cohort 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has had a single contained or noncontained (extruded) lumbar disc herniation (L3-L4, L4-L5 or L5-S1) diagnosed by clinical symptoms and/or physical findings and confirmed by MRI.\n* Subject has leg pain with a documented positive straight leg raise (SLR) test or femoral stretch test (FST).\n* Subject has experiences herniated disc symptoms for at least 6 weeks prior to the study without relief with pain medications and other therapies.\n* Subject has a BMI of 18 to 35 kg/m2\n\nExclusion Criteria:\n\n* Subject has a sequestered lumbar disc herniation or intrathecal herniation confirmed by MRI\n* Subject has two or more symptomatic lumbar disc herniations\n* Previous intradiscal therapeutic intervention or has had any lumbar surgery\n* Presence of lumbar spine disease and/or deformity other than a lumbar disc herniation\n* Active smoker or is unable to abstain from tobacco use for 2 weeks prior to study injection\n* Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT01978912', 'briefTitle': 'A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teijin America, Inc.'}, 'officialTitle': 'Open-Label, Non-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation', 'orgStudyIdInfo': {'id': 'KTP-001-CL-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'one time 5 μg/disc dose of KTP-001 by intradiscal injection', 'interventionNames': ['Drug: KTP-001']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'one time 15 μg/disc dose of KTP-001 by intradiscal injection', 'interventionNames': ['Drug: KTP-001']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'one time 50 μg/disc dose of KTP-001 by intradiscal injection', 'interventionNames': ['Drug: KTP-001']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'one time 150 μg/disc dose of KTP-001 by intradiscal injection', 'interventionNames': ['Drug: KTP-001']}], 'interventions': [{'name': 'KTP-001', 'type': 'DRUG', 'description': 'KTP-001 is one time dose intradiscally.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'CORE Orthopaedic Medical Center', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Spine Diagnostic', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Anesthesia Pain Specialists', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Kentucky Research Associates, Inc.', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teijin America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}