Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284556
• Other study ID #: AGG-901
• Secondary ID: 2010-020871-22
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2011
• Last updated: November 9, 2017
• Start date: November 2010
• Est. completion date: April 2016

Study information

• Verified date: November 2017
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: April 2016
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Phenobarbital
tablet
• Placebo tablet
tablet

Locations

Country	Name	City	State
Puerto Rico	Centro Neurodiagnostico	Rio Piedras
Puerto Rico	Hospital Del Maestro	San Juan
United States	Bluegrass Epilepsy Research	Lexington	Kentucky
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
West-Ward Pharmaceutical

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency	determination of partial onset seizure frequency per week over the treatment period; comparison of average change in weekly seizure rate from baseline and maintenance period	34 weeks with maximum 22-week exposure to phenobarbital
Secondary	Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses		34 weeks with a maximum 22-week exposure to phenobarbital
Secondary	Assess the effects of phenobarbital on Type I seizures	seizure freedom rate; percent reduction for partial onset seizure; responder rate; reduction of seizure frequency	34 weeks with a maximum 22-week exposure to phenobarbital
Secondary	Assess the safety of phenobarbital	overview of adverse events in study; summary of adverse events in study by severity, seriousness, relationship to study drug, action taken, outcome, treatment; summary of serious adverse events	34 weeks with a maximum 22-week exposure to phenobarbital
Secondary	Assess the tolerability of phenobarbital		34 weeks with maximum 22-week exposure to phenobarbital