Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-21 @ 11:15 AM
Study NCT ID:
NCT03370120
Status:
TERMINATED
Last Update Posted:
2021-12-29
First Post:
2017-12-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708857', 'term': 'padsevonil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'UCBCares@ucb.com', 'phone': '001-844-599-2273', 'title': 'UCB', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)', 'description': 'A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Padsevonil (SS)', 'description': 'Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.', 'otherNumAtRisk': 406, 'deathsNumAtRisk': 406, 'otherNumAffected': 184, 'seriousNumAtRisk': 406, 'deathsNumAffected': 0, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 76, 'numAffected': 66}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 138, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 63, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 38, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 56, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 42, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}], 'seriousEvents': [{'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Mycoplasma test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Phyllodes tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Focal dyscognitive seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Partial seizures with secondary generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Postictal state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Seizure cluster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Pelvi-ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Vagal nerve stimulator implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Participant and/or Caregiver or Observed by the Investigator During the Entire Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Padsevonil (SS)', 'description': 'Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the Safety Set (SS).'}], 'classes': [{'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)', 'description': 'An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication CRF.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Padsevonil (SS)', 'description': 'Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)', 'description': 'An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SS consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication CRF.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Padsevonil (FAS)', 'description': 'Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the FAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.73', 'spread': '27.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study', 'description': 'Seizure frequency refers to 28-day adjusted frequency. Observable focal-onset seizures refer to Type IAl, IB, and IC (according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981). Focal-onset seizures include all Type I seizures.', 'unitOfMeasure': 'seizures per 28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all enrolled participants who were administered at least 1 dose of PSL or a partial dose of PSL and completed at least 1 seizure diary during the Evaluation Period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Padsevonil', 'description': 'Participants received padsevonil tablets at a dose of 100 milligrams/day (mg/day) to 800 mg/day up to approximately 2 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '406'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '406'}]}], 'dropWithdraws': [{'type': 'Adverse event, non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': "Per sponsor's instructions", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study was terminated by parent company UCB', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'The study was ended by the promoter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Discontinuation of drug development', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'End of project', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Premature study closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Premature program termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Premature study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Trial terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Trial discontinued by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Study ended', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Clinical trial has been cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'End of study per sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': "Promoter's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'The trial has been suspended', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Sponsor stopped PSL development based on data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Early termination by order of sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Discontinuation of the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'End of clinical trial discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Because the clinical trial ended halfway', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Development discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Padsenovil program closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'End of project', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Termination of project', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'The study was interrupted by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'The protocol was interrupted by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'End of sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'The study was terminated prematurely by study lead', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Early termination of studies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'This study is ended early', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'End of padsevonil program', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Decision of sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Asked by the sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Sponsor decision to stop the protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'PI decision poor compliance from participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Promoter ended the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': "Premature study close by sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Sponsor prematurely terminated this study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Sponsor decision to terminate study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'Program closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Study ended prematurely', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study stopped by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Program termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'Sponsor study closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'The study started to enroll study participants in August 2018 and concluded in December 2020.', 'preAssignmentDetails': 'Participant Flow refers to the Safety Set. Participants who had completed a padsevonil (PSL) parent study (EP0091 \\[NCT03373383\\] or EP0092 \\[NCT03739840\\]) were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Padsevonil', 'description': 'Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '395', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '231', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '175', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian / Alaskan native', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '343', 'groupId': 'BG000'}]}]}, {'title': 'Other/mixed', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Set (SS) consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication Case Report form (CRF).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-04', 'size': 2066456, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-30T09:15', 'hasProtocol': True}, {'date': '2020-09-25', 'size': 1898510, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-30T09:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'whyStopped': 'Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2017-12-07', 'resultsFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-30', 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Participant and/or Caregiver or Observed by the Investigator During the Entire Study', 'timeFrame': 'From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)', 'description': 'An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.'}, {'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal', 'timeFrame': 'From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)', 'description': 'An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.'}, {'measure': 'Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period', 'timeFrame': 'From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study', 'description': 'Seizure frequency refers to 28-day adjusted frequency. Observable focal-onset seizures refer to Type IAl, IB, and IC (according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981). Focal-onset seizures include all Type I seizures.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-Resistant Epilepsy', 'Padsevonil'], 'conditions': ['Drug-Resistant Epilepsy', 'Focal-Onset Seizures']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is an adult (18 years of age or more )\n* Subject with epilepsy who has completed 1 of the previous Padsevonil (PSL) studies which allow access to the present study\n* Female subjects of child bearing potential must have a serum negative pregnancy test at the Entry Visit, which is confirmed to be negative by urine testing prior to further dispensing at each study visit thereafter. Subjects will be withdrawn from the study as soon as pregnancy is known. Female subjects will use an efficient form of contraception for the duration of the study and for a period of 3 months after their final dose of PSL.\n\nExclusion Criteria:\n\n* Subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject\n* Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Subject has \\>2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>ULN total bilirubin (\\>= l.5x ULN total bilirubin if known Gilbert's syndrome) at the Entry Visit\n* Subject has a clinically-significant abnormality on electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Subject has an abnormality on echocardiogram at last echocardiogram assessment, or foreseen in parent study as assessed by central reader that is accompanied by clinical symptoms or a Grade 2\\* (or higher)/moderate severity abnormality, or a history of rheumatic heart disease, or other known valvular abnormalities (\\*according to the ASE Guidelines, 2017; Zoghbi et al 2017)\n* Female subject who plans to be pregnant or is breastfeeding"}, 'identificationModule': {'nctId': 'NCT03370120', 'briefTitle': 'Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy', 'orgStudyIdInfo': {'id': 'EP0093'}, 'secondaryIdInfos': [{'id': '2017-003241-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Padsevonil', 'description': 'Padsevonil will be administered in an open-label manner. The individual starting dose of each subject will be the one at the end of the parent study.\n\nOnce subjects enter EP0093 further individual dose adjustments are allowed after 1 week to the extent possible with the combination of tablet strengths available.', 'interventionNames': ['Drug: Padsevonil']}], 'interventions': [{'name': 'Padsevonil', 'type': 'DRUG', 'description': '* Pharmaceutical Form: film-coated tablet\n* Route of Administration: Oral use', 'armGroupLabels': ['Padsevonil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85226', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ep0093 839', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Ep0093 815', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ep0093 801', 'geoPoint': 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'Belgium', 'facility': 'Ep0093 100', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Ottignies', 'country': 'Belgium', 'facility': 'Ep0093 107', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'city': 'Sarajevo', 'country': 'Bosnia and Herzegovina', 'facility': 'Ep0093 075', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'city': 'Tuzla', 'country': 'Bosnia and Herzegovina', 'facility': 'Ep0093 082', 'geoPoint': {'lat': 44.53842, 'lon': 18.66709}}, {'city': 'Blagoevgrad', 'country': 'Bulgaria', 'facility': 'Ep0093 150', 'geoPoint': {'lat': 42.01457, 'lon': 23.09804}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Ep0093 151', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Ep0093 153', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Ep0093 156', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Ep0093 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{'city': 'Prague', 'country': 'Czechia', 'facility': 'Ep0093 250', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Ep0093 251', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Ep0093 253', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Ep0093 016', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Ep0093 015', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Ep0093 276', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Ep0093 277', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'facility': 'Ep0093 275', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Ep0093 027', 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{'city': 'Cork', 'country': 'Ireland', 'facility': 'Ep0093 035', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Ep0093 462', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Cagliari', 'country': 'Italy', 'facility': 'Ep0093 450', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Foggia', 'country': 'Italy', 'facility': 'Ep0093 451', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'city': 'Foggia', 'country': 'Italy', 'facility': 'Ep0093 461', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ep0093 452', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Ep0093 459', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pozzilli', 'country': 'Italy', 'facility': 'Ep0093 458', 'geoPoint': {'lat': 41.51142, 'lon': 14.06252}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ep0093 455', 'geoPoint': {'lat': 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{'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Ep0093 604', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Ep0093 610', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Nowa Sól', 'country': 'Poland', 'facility': 'Ep0093 606', 'geoPoint': {'lat': 51.80333, 'lon': 15.71702}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Ep0093 600', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Ep0093 609', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Świdnik', 'country': 'Poland', 'facility': 'Ep0093 602', 'geoPoint': {'lat': 51.21898, 'lon': 22.69621}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Ep0093 926', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Ep0093 327', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Bardejov', 'country': 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'United Kingdom', 'facility': 'Ep0093 764', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': '001 844 599 2273 (UCB)'}]}, 'ipdSharingStatementModule': {'url': 'http://www.Vivli.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.', 'ipdSharing': 'YES', 'description': 'Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.', 'accessCriteria': 'Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma SRL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}