Epilepsy
Conditions
Keywords
partial onset seizures
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.
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
DRUGPhenobarbital
tablet
DRUGPlacebo tablet
tablet
Sponsors
West-Ward Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Puerto Rico, United States
Outcome results
None listed