Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01284556
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2011-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
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': 'D010634', 'term': 'Phenobarbital'}], 'ancestors': [{'id': 'D001463', 'term': 'Barbiturates'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-09', 'studyFirstSubmitDate': '2011-01-20', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency', 'timeFrame': '34 weeks with maximum 22-week exposure to phenobarbital', 'description': '* determination of partial onset seizure frequency per week over the treatment period\n* comparison of average change in weekly seizure rate from baseline and maintenance period'}], 'secondaryOutcomes': [{'measure': 'Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses', 'timeFrame': '34 weeks with a maximum 22-week exposure to phenobarbital'}, {'measure': 'Assess the effects of phenobarbital on Type I seizures', 'timeFrame': '34 weeks with a maximum 22-week exposure to phenobarbital', 'description': '* seizure freedom rate\n* percent reduction for partial onset seizure\n* responder rate\n* reduction of seizure frequency'}, {'measure': 'Assess the safety of phenobarbital', 'timeFrame': '34 weeks with a maximum 22-week exposure to phenobarbital', 'description': '* overview of adverse events in study\n* summary of adverse events in study by severity, seriousness, relationship to study drug, action taken, outcome, treatment\n* summary of serious adverse events'}, {'measure': 'Assess the tolerability of phenobarbital', 'timeFrame': '34 weeks with maximum 22-week exposure to phenobarbital'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['partial onset seizures'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Primary:\n\n\\- to evaluate the efficacy of phenobarbital in reducing seizure frequency.\n\nSecondary:\n\n* to confirm dose response relationship,\n* to assess the effects on Type I seizures,\n* to assess the safety of phenobarbital\n* to assess the drug tolerability.', 'detailedDescription': 'Primary:\n\n-to evaluate the efficacy of once daily (OD) administration of 60 mg and 100 mg phenobarbital, in reducing seizure frequency in participants with partial onset seizures (Type I seizures; complex or simple with motor symptoms only) not fully controlled despite treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs with Vagus Nerve Stimulator (VNS)\n\nSecondary:\n\n* to confirm dose response relationship of 60 and 100 mg phenobarbital doses,\n* to assess the effects of phenobarbital on Type I seizures,\n* to assess the safety of phenobarbital\n* to assess the tolerability of phenobarbital'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants from 17 to 70 years old;\n* history of Type I partial onset seizures (complex or simple with motor symptoms only);\n* participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures;\n* participants having at least eight Type I partial onset seizures during 8-week baseline period;\n* participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS);\n* participant has been on a stable dose of their current anti-epileptic treatment regime\n\nExclusion Criteria:\n\n* currently taking phenobarbital or primidone;\n* currently taking felbamate or vigabatrin;\n* history of prior allergic reaction to phenobarbital;\n* history of psychogenic seizures;\n* history or presence of status epilepticus;\n* history or presence of seizures occurring only in clusters;\n* participant taking any drug with possible Central Nervous System (CNS) effects except if stable from 1 month prior Visit 1;\n* history of cerebrovascular accident (CVA) or transient ischemic attack (TIA);\n* presence of any sign suggesting rapidly progressing brain disorder or brain tumor;\n* presence of unstable arteriovenous malformations, meningiomas or other benign tumors;\n* history of porphyria;\n* presence of clinically significant findings on physical exam, vital signs, electrocardiogram (ECG) or safety lab assessments, including renal or hepatic insufficiency;\n* history of alcohol or drug abuse within the year prior to screening;\n* participant who is known to be non-compliant;\n* participant who is male or female who refuses to use an acceptable form of contraception;\n* female who is pregnant or lactating or intends to become pregnant;\n* participant who has taken part in any investigational device or product within 2 months prior to the screening visit'}, 'identificationModule': {'nctId': 'NCT01284556', 'briefTitle': 'Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'West-Ward Pharmaceutical'}, 'officialTitle': 'An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Phenobarbital as Adjunctive Therapy in Participants (> or = 17 to 70 Years Old) With Partial Onset Seizures', 'orgStudyIdInfo': {'id': 'AGG-901'}, 'secondaryIdInfos': [{'id': '2010-020871-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo tablets', 'interventionNames': ['Drug: Placebo tablet']}, {'type': 'EXPERIMENTAL', 'label': '60 mg group', 'description': 'Patients titrated to 60mg phenobarbital for maintenance period, then titrated down.', 'interventionNames': ['Drug: Phenobarbital']}, {'type': 'EXPERIMENTAL', 'label': '100 mg group', 'description': 'Patients titrated to 100mg phenobarbital maintenance period, then titrated down', 'interventionNames': ['Drug: Phenobarbital']}], 'interventions': [{'name': 'Phenobarbital', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['100 mg group', '60 mg group']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Epilepsy Research', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '00927', 'city': 'San Juan', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Hospital Del Maestro', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00924', 'city': 'Rio Piedras', 'country': 'Puerto Rico', 'facility': 'Centro Neurodiagnostico', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West-Ward Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}