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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
314
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Bluegrass Epilepsy Research
Lexington, Kentucky, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Hospital Del Maestro
San Juan, PR, Puerto Rico
Centro Neurodiagnostico
Rio Piedras, Puerto Rico
Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
* 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
Time frame: 34 weeks with maximum 22-week exposure to phenobarbital
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
* seizure freedom rate * percent reduction for partial onset seizure * responder rate * reduction of seizure frequency
Time frame: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the safety of 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
Time frame: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the tolerability of phenobarbital
Time frame: 34 weeks with maximum 22-week exposure to phenobarbital
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