Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-29 @ 2:38 PM
Study NCT ID:
NCT01167335
Status:
WITHDRAWN
Last Update Posted:
2012-05-01
First Post:
2010-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591013', 'term': 'selurampanel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'lastUpdateSubmitDate': '2012-04-30', 'studyFirstSubmitDate': '2010-06-25', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.', 'timeFrame': '28 days'}, {'measure': 'Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks', 'timeFrame': '12 weeks'}, {'measure': 'Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.)', 'timeFrame': '10 weeks'}]}, 'conditionsModule': {'keywords': ['partial onset seizure', 'seizure frequency', 'nervous system diseases', 'central nervous system diseases', 'CNS', 'brain diseases', 'neurologic manifestations', 'adjunctive treatment', 'AEDs', 'antiepileptic drug'], 'conditions': ['Partial Onset Seizures']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients ≥ 50 kg (110 lb) of weight\n* A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures\n* Uncontrolled partial seizures despite having been treated with at least two different AEDs within the last 2 years prior to screening.\n* Treated with a stable dose of 1-2 AEDs\n* At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.\n* No 28-day seizure-free period during the 8 weeks preceding randomization\n* Positive biomarker screening\n\nExclusion Criteria:\n\n* Presence of only non-motor simple partial seizures\n* History of psychogenic seizures\n* Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;\n* Previous history of Lennox-Gastaut syndrome\n* Pregnant or nursing (lactating) women\n* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01167335', 'briefTitle': 'Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures', 'orgStudyIdInfo': {'id': 'CBGG492A2211'}, 'secondaryIdInfos': [{'id': '2010-018766-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BGG492', 'interventionNames': ['Drug: BGG492']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BGG492', 'type': 'DRUG', 'armGroupLabels': ['BGG492']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Epilepsy Care Specialists, S.C.', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'A-5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 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'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}