Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2013

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

Interventions

  • Drug: Phenobarbital
    • tablet
  • Drug: Placebo tablet
    • tablet

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • placebo tablets
  • Experimental: 60 mg group
    • Patients titrated to 60mg phenobarbital for maintenance period, then titrated down.
  • Experimental: 100 mg group
    • Patients titrated to 100mg phenobarbital maintenance period, then titrated down

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
    • Time Frame: 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 Measures

  • Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses
    • Time Frame: 34 weeks with a maximum 22-week exposure to phenobarbital
  • Assess the effects of phenobarbital on Type I seizures
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 34 weeks with maximum 22-week exposure to phenobarbital

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • West-Ward Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor

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