NCT01284556

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: West-Ward Pharmaceutical · Industry
• Sex: All
• Age: 17 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Phenobarbital	tablet
DRUG	Placebo tablet	tablet

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-01-01
• Completion: 2016-04-01
• First posted: 2011-01-27
• Last updated: 2017-11-14

Locations

4 sites across 2 countries: United States, Puerto Rico