Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West-Ward Pharmaceutical
• Treatments: Phenobarbital

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