Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-11 @ 12:31 AM
Study NCT ID:
NCT00175851
Status:
WITHDRAWN
Last Update Posted:
2012-05-28
First Post:
2005-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518915', 'term': 'Seletracetam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'lastUpdateSubmitDate': '2012-05-25', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety profile of seletracetam'}], 'secondaryOutcomes': [{'measure': 'Reduction in seizure frequency'}]}, 'conditionsModule': {'keywords': ['Partial onset, primary generalized seizures, seletracetam'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A signed and dated IRB/IEC approved written informed consent form\n* Male/female age 18 years (16 years where permitted) to 65 years\n* Minimum body weight of 40 kg\n* Patients having participated in a previous seletracetam study\n* Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.\n\nExclusion Criteria:\n\n* Ongoing psychiatric disease other than mild controlled disorders\n* Subject with clinically significant abnormalities in laboratory tests or ECG\n* Poor compliance with visit schedule or medication intake in a previous seletracetam study\n* Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment'}, 'identificationModule': {'nctId': 'NCT00175851', 'briefTitle': 'Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open-label, Multicenter, Follow-up Trial to Evaluate the Long-term Safety and Efficacy of Seletracetam Used as Adjunctive Treatment Using a Flexible Dosing Scheme of 4 to 80 mg b.i.d. in Subjects Aged 16 Years or Older Suffering From Epilepsy', 'orgStudyIdInfo': {'id': 'N01197'}, 'secondaryIdInfos': [{'id': 'Not yet available'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Seletracetam (ucb 44212)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Barbara Bennett, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCB Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'UCB'}}}}