Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

NCT ID: NCT01284556

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-04-30

Brief 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

Keywords

partial onset seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

tablet

60 mg group

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

Group Type: EXPERIMENTAL

Phenobarbital

Intervention Type: DRUG

tablet

100 mg group

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

Group Type: EXPERIMENTAL

Phenobarbital

Intervention Type: DRUG

tablet

Interventions

Phenobarbital

tablet

Intervention Type: DRUG

Placebo tablet

tablet

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West-Ward Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bluegrass Epilepsy Research

Lexington, Kentucky, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Hospital Del Maestro

San Juan, PR, Puerto Rico

Centro Neurodiagnostico

Rio Piedras, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

2010-020871-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AGG-901

Identifier Type: -

Identifier Source: org_study_id