Clinical trial NCT01284556: Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: partial onset seizures
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 314
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
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
Secondary outcomes:
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
measure: Assess the safety of phenobarbital
timeFrame: 34 weeks with a maximum 22-week exposure to phenobarbital
measure: Assess the tolerability of phenobarbital
timeFrame: 34 weeks with maximum 22-week exposure to phenobarbital
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Bluegrass Epilepsy Research
state: Kentucky
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Rio Piedras
country: Puerto Rico
facility: Centro Neurodiagnostico
city: San Juan
country: Puerto Rico
facility: Hospital Del Maestro
Study officials:
References: