Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-29 @ 6:13 AM
Study NCT ID:
NCT04873232
Status:
COMPLETED
Last Update Posted:
2025-10-09
First Post:
2021-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jinsub.lee@helixmith.com', 'phone': '+82-10-8256-0439', 'title': 'Jinsub Lee, PhD', 'organization': 'Helixmith, Co., LTD'}, 'certainAgreement': {'otherDetails': "There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365.', 'description': 'For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365.\n\nTwo participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Engensis', 'description': 'Patients who have received Engensis in protocol VMDN-003-2\n\nEngensis: Injections with Engensis in study VMDN-003-2', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 16, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients who have received Placebo in protocol VMDN-003-2\n\nPlacebo: Injections with Placebo in study VMDN-003-2', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 22, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Gastoenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Post procedural cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Conjunctival oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Dry age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Blood creatinine abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Blood urea abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Colorectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Post procedural cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Evaluate the Efficacy of Intramuscular Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engensis', 'description': 'Patients who have received Engensis in protocol VMDN-003-2\n\nEngensis: Injections with Engensis in study VMDN-003-2'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who have received Placebo in protocol VMDN-003-2\n\nPlacebo: Injections with Placebo in study VMDN-003-2'}], 'classes': [{'title': 'Change from Baseline to Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.27', 'spread': '2.083', 'groupId': 'OG000'}, {'value': '-2.62', 'spread': '2.087', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 7 Days prior to the Day 365 visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.53', 'spread': '2.173', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '2.126', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the 7 days prior to the Day 0 Visit (Study VMDN-003-2, NCT04469270), Day 270, to the 7 days prior to the Day 365 Visit in the intent-to-treat population', 'description': 'Change in the means of the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit in the intent-to-treat population. The mean of the Average Daily Pain Scores are used for the primary endpoint recorded in the 7 days prior to the Days 270 and 365/ET Visits. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine.\n\nThe mean of at least 5 daily pain scores recorded for Question 5 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy scale in electronic diary during the 7 days prior to the visits on Days 270 and 365/Early termination. The greater the negative difference between the followup visit and the Day 0 Baseline for each group for the average daily pain score in participants, would indicate that the average daily pain is declining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Summary of Change from Baseline to Day 365 in ADPS (Intent-To-Treat Population)'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Efficacy of IM Administration of Engensis on the Worst Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engensis', 'description': 'Patients who have received Engensis in protocol VMDN-003-2\n\nEngensis: Injections with Engensis in study VMDN-003-2'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who have received Placebo in protocol VMDN-003-2\n\nPlacebo: Injections with Placebo in study VMDN-003-2'}], 'classes': [{'title': 'Change from Baseline to Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.50', 'spread': '2.376', 'groupId': 'OG000'}, {'value': '-2.94', 'spread': '2.664', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.65', 'spread': '2.485', 'groupId': 'OG000'}, {'value': '-3.19', 'spread': '2.454', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit for Engensis compared to Placebo', 'description': 'Change in the means of the Worst Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to Day 0 Visit (Study VMDN-003-2), to Day 270, and 7 days prior to the Day 365 Visit for Engensis compared to Placebo. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine.\n\nThe mean of at least 5 worst daily pain scores recorded for Question 3 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy in the electronic diary during the 7 days prior to the Visits on Days 270 and 365/Early termination. The greater the negative difference between the followup visit and the Day 0 Baseline for each group for the worst pain score in participants, would indicate that the worst pain is declining.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Summary of Change from Day 0, Baseline, to Day 270, and Day 365 in Worst Pain Score (MI) (Intent-To-Treat Population)'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Safety of IM Administration of Engensis in the Number of Participants With Painful DPN in the Feet and Lower Legs as Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engensis', 'description': 'Patients who have received Engensis in protocol VMDN-003-2\n\nEngensis: Injections with Engensis in study VMDN-003-2'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who have received Placebo in protocol VMDN-003-2\n\nPlacebo: Injections with Placebo in study VMDN-003-2'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 Visit (Study VMDN-003-2) to the Day 365 Visit', 'description': 'Number of participants with adverse events and serious adverse events for Engensis compared to Placebo, including the number of participants with clinically significant laboratory values for Engensis compared to Placebo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Summary of number of participants with Adverse Events (Safety Population)'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Efficacy of Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engensis', 'description': 'Patients who have received Engensis in protocol VMDN-003-2\n\nEngensis: Injections with Engensis in study VMDN-003-2'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who have received Placebo in protocol VMDN-003-2\n\nPlacebo: Injections with Placebo in study VMDN-003-2'}], 'classes': [{'title': 'Responders with ≥50% reduction by Day 270', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Responders with ≥50% reduction by Day 365', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the 7 days prior to the Day 0 Visit (Study VMDN-003-2), to the 7 days prior to the Day 270 Visit, and 7 days prior to the Day 365 Visit', 'description': 'Proportion of Responders (≥ 50% reduction in the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy) from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 270 Visit and the 7 days prior to the Day 365 Visit for Engensis compared to Placebo.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Summary of Participant Responders with ≥50% reduction from Baseline Day 0 visit, in the Average Daily Pain Score to the 7 days prior to Day 270 and 7 days prior to the Day 365 visit (Intent-To-Treat Population)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Engensis', 'description': 'Patients who have received Engensis in protocol VMDN-003-2\n\nEngensis: Injections with Engensis in study VMDN-003-2'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients who have received Placebo in protocol VMDN-003-2\n\nPlacebo: Injections with Placebo in study VMDN-003-2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Qualified subjects were anyone that completed the Day 180 visit in VMDN-003-2 (NCT04469270) and provided informed consent to be followed for another 6 months in this extension protocol VMDN-003-2b (NCT04873232). Subjects did not receive any further investigational prouct interventions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Engensis', 'description': 'Patients who have received Engensis in protocol VMDN-003-2\n\nEngensis: Injections with Engensis in study VMDN-003-2'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients who have received Placebo in protocol VMDN-003-2\n\nPlacebo: Injections with Placebo in study VMDN-003-2'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-11', 'size': 21365148, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-29T18:22', 'hasProtocol': True}, {'date': '2023-10-06', 'size': 3528218, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-29T18:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2021-02-18', 'resultsFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-01-10', 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Evaluate the Efficacy of Intramuscular Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo', 'timeFrame': 'From the 7 days prior to the Day 0 Visit (Study VMDN-003-2, NCT04469270), Day 270, to the 7 days prior to the Day 365 Visit in the intent-to-treat population', 'description': 'Change in the means of the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit in the intent-to-treat population. The mean of the Average Daily Pain Scores are used for the primary endpoint recorded in the 7 days prior to the Days 270 and 365/ET Visits. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine.\n\nThe mean of at least 5 daily pain scores recorded for Question 5 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy scale in electronic diary during the 7 days prior to the visits on Days 270 and 365/Early termination. The greater the negative difference between the followup visit and the Day 0 Baseline for each group for the average daily pain score in participants, would indicate that the average daily pain is declining.'}], 'secondaryOutcomes': [{'measure': 'To Evaluate the Efficacy of IM Administration of Engensis on the Worst Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo', 'timeFrame': 'From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit for Engensis compared to Placebo', 'description': 'Change in the means of the Worst Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to Day 0 Visit (Study VMDN-003-2), to Day 270, and 7 days prior to the Day 365 Visit for Engensis compared to Placebo. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine.\n\nThe mean of at least 5 worst daily pain scores recorded for Question 3 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy in the electronic diary during the 7 days prior to the Visits on Days 270 and 365/Early termination. The greater the negative difference between the followup visit and the Day 0 Baseline for each group for the worst pain score in participants, would indicate that the worst pain is declining.'}, {'measure': 'To Evaluate the Safety of IM Administration of Engensis in the Number of Participants With Painful DPN in the Feet and Lower Legs as Compared to Placebo', 'timeFrame': 'From Day 0 Visit (Study VMDN-003-2) to the Day 365 Visit', 'description': 'Number of participants with adverse events and serious adverse events for Engensis compared to Placebo, including the number of participants with clinically significant laboratory values for Engensis compared to Placebo'}, {'measure': 'To Evaluate the Efficacy of Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs', 'timeFrame': 'From the 7 days prior to the Day 0 Visit (Study VMDN-003-2), to the 7 days prior to the Day 270 Visit, and 7 days prior to the Day 365 Visit', 'description': 'Proportion of Responders (≥ 50% reduction in the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy) from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 270 Visit and the 7 days prior to the Day 365 Visit for Engensis compared to Placebo.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'To evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.', 'detailedDescription': 'The purpose of this 6-month extension study (VMDN-003-2b) is to evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study. No treatments will be administered in this VMDN-003-2b extension study. The combined overall duration of the VMDN-003-2 and VMDN-003-2b studies will be 12 months.\n\nParticipants will be enrolled in the VMDN-003-2b study at completion of the Day 180 Visit of Study VMDN-003-2. Participants will continue to be identified by the same Participant number and the same treatment group (Engensis or Placebo) assigned by randomization in Study VMDN-003-2. No study drug or treatment will be administered in this VMDN-003-2b extension study. The double-blind treatment assignment from the prior study will be maintained for Investigators and Participants during this extension study.\n\nThis extension study will assess the durability of efficacy and long-term safety of Engensis compared to Placebo as measured by changes in Average Daily Pain Score of the full Brief Pain Inventory for Diabetic Peripheral Neuropathy, Bedside sensory testing, physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04873232', 'acronym': 'REGAiN-1B', 'briefTitle': 'A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Helixmith Co., Ltd.'}, 'officialTitle': 'A 6-Month Extension Study Following Protocol VMDN-003-2 - An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'VMDN-003-2b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Engensis', 'description': 'Patients who have received Engensis in protocol VMDN-003-2', 'interventionNames': ['Biological: Engensis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients who have received Placebo in protocol VMDN-003-2', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Engensis', 'type': 'BIOLOGICAL', 'description': 'Injections with Engensis in study VMDN-003-2', 'armGroupLabels': ['Engensis']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Injections with Placebo in study VMDN-003-2', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Trials - Little Rock', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Medical Clinic for Headache', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research - Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research of West Florida, Inc.', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '62269', 'city': "O'Fallon", 'state': 'Illinois', 'country': 'United States', 'facility': 'Gateway Clinical Trials, LLC', 'geoPoint': {'lat': 38.59227, 'lon': -89.91121}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Foot & Ankle Center of Illinois', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Research Professionals', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '10314', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Richmond Behavioral Associates', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Health Concepts', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Nerve and Muscle Center of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78501', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Futuro Clinical Trials', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '75165', 'city': 'Waxahachie', 'state': 'Texas', 'country': 'United States', 'facility': 'ClinPoint Trials LLC', 'geoPoint': {'lat': 32.38653, 'lon': -96.84833}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Manassas Clinical Research Center', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Dominion Medical Associates', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helixmith Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}