Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
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
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