Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 1:33 AM
Study NCT ID:
NCT01147003
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2010-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015507', 'term': 'Drugs, Investigational'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'dispFirstSubmitDate': '2013-02-18', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2010-06-15', 'dispFirstSubmitQcDate': '2013-02-18', 'studyFirstSubmitQcDate': '2010-06-16', 'dispFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.', 'timeFrame': '28 days'}, {'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.', 'timeFrame': '12 weeks'}, {'measure': 'Pharmacokinetic profile of BGG492', 'timeFrame': '10 weeks'}]}, 'conditionsModule': {'keywords': ['Seizure frequency', 'nervous system diseases', 'brain diseases', 'neurologic manifestations', 'adjunctive treatment', 'AEDs', 'antiepileptic drug'], 'conditions': ['Partial Onset Seizures']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7124', 'label': 'Results for CBGG492A2207 on the Novartis clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the 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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* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization.\n* Pregnant or nursing (lactating) women.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01147003', 'briefTitle': 'Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules as Adjunctive Treatment in Patients With Partial Onset Seizures', 'orgStudyIdInfo': {'id': 'CBGG492A2207'}, 'secondaryIdInfos': [{'id': '2009-017961-52', 'type': 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