Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
Study Details
Study Description
Brief Summary
Primary:
- to evaluate the efficacy of phenobarbital in reducing seizure frequency.
Secondary:
-
to confirm dose response relationship,
-
to assess the effects on Type I seizures,
-
to assess the safety of phenobarbital
-
to assess the drug tolerability.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Primary:
-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)
Secondary:
-
to confirm dose response relationship of 60 and 100 mg phenobarbital doses,
-
to assess the effects of phenobarbital on Type I seizures,
-
to assess the safety of phenobarbital
-
to assess the tolerability of phenobarbital
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo placebo tablets |
Drug: Placebo tablet
tablet
|
| Experimental: 60 mg group Patients titrated to 60mg phenobarbital for maintenance period, then titrated down. |
Drug: Phenobarbital
tablet
|
| Experimental: 100 mg group Patients titrated to 100mg phenobarbital maintenance period, then titrated down |
Drug: Phenobarbital
tablet
|
Outcome Measures
Primary Outcome Measures
- Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency [34 weeks with maximum 22-week exposure to phenobarbital]
determination of partial onset seizure frequency per week over the treatment period comparison of average change in weekly seizure rate from baseline and maintenance period
Secondary Outcome Measures
- Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses [34 weeks with a maximum 22-week exposure to phenobarbital]
- Assess the effects of phenobarbital on Type I seizures [34 weeks with a maximum 22-week exposure to phenobarbital]
seizure freedom rate percent reduction for partial onset seizure responder rate reduction of seizure frequency
- Assess the safety of phenobarbital [34 weeks with a maximum 22-week exposure to phenobarbital]
overview of adverse events in study summary of adverse events in study by severity, seriousness, relationship to study drug, action taken, outcome, treatment summary of serious adverse events
- Assess the tolerability of phenobarbital [34 weeks with maximum 22-week exposure to phenobarbital]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
participants from 17 to 70 years old;
-
history of Type I partial onset seizures (complex or simple with motor symptoms only);
-
participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures;
-
participants having at least eight Type I partial onset seizures during 8-week baseline period;
-
participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS);
-
participant has been on a stable dose of their current anti-epileptic treatment regime
Exclusion Criteria:
-
currently taking phenobarbital or primidone;
-
currently taking felbamate or vigabatrin;
-
history of prior allergic reaction to phenobarbital;
-
history of psychogenic seizures;
-
history or presence of status epilepticus;
-
history or presence of seizures occurring only in clusters;
-
participant taking any drug with possible Central Nervous System (CNS) effects except if stable from 1 month prior Visit 1;
-
history of cerebrovascular accident (CVA) or transient ischemic attack (TIA);
-
presence of any sign suggesting rapidly progressing brain disorder or brain tumor;
-
presence of unstable arteriovenous malformations, meningiomas or other benign tumors;
-
history of porphyria;
-
presence of clinically significant findings on physical exam, vital signs, electrocardiogram (ECG) or safety lab assessments, including renal or hepatic insufficiency;
-
history of alcohol or drug abuse within the year prior to screening;
-
participant who is known to be non-compliant;
-
participant who is male or female who refuses to use an acceptable form of contraception;
-
female who is pregnant or lactating or intends to become pregnant;
-
participant who has taken part in any investigational device or product within 2 months prior to the screening visit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bluegrass Epilepsy Research | Lexington | Kentucky | United States | 40504 |
| 2 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 3 | Centro Neurodiagnostico | Rio Piedras | Puerto Rico | 00924 | |
| 4 | Hospital Del Maestro | San Juan | Puerto Rico | 00927 |
Sponsors and Collaborators
- West-Ward Pharmaceutical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AGG-901
- 2010-020871-22