Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

Completed · Phase 3 · Has a placebo group

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01284556

Run by

West-Ward Pharmaceutical

People needed

314

Starts

2010-11-01

Expected to finish

2016-04-01

Last updated by the study team

2017-11-14

Who can join

Age: 17 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.