Trial | NCT01284556  Report issue

Title

Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    phenobarbital ...

  • Study Participants

    314
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 Started
Nov 30
2010
Primary Completion
Jan 31
2013
Study Completion
Apr 30
2016
Last Update
Nov 14
2017

Drug Phenobarbital

tablet

Drug Placebo tablet

tablet

Placebo Placebo Comparator

placebo tablets

60 mg group Experimental

Patients titrated to 60mg phenobarbital for maintenance period, then titrated down.

100 mg group Experimental

Patients titrated to 100mg phenobarbital maintenance period, then titrated down

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
No Results Posted