Overview

This trial is active, not recruiting.

Condition epilepsy
Treatments phenobarbital, placebo tablet
Phase phase 3
Sponsor West-Ward Pharmaceutical
Start date November 2010
End date March 2013
Trial size 345 participants
Trial identifier NCT01284556, 2010-020871-22, AGG-901

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
placebo tablets
placebo tablet
tablet
(Experimental)
Patients titrated to 60mg phenobarbital for maintenance period, then titrated down.
phenobarbital
tablet
(Experimental)
Patients titrated to 100mg phenobarbital maintenance period, then titrated down
phenobarbital
tablet

Primary Outcomes

Measure
Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
time frame: 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
time frame: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the effects of phenobarbital on Type I seizures
time frame: 34 weeks with a maximum 22-week exposure to phenobarbital
Assess the safety of phenobarbital
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

Eligibility Criteria

Male or female participants from 17 years up to 70 years old.

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

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by West-Ward Pharmaceutical.