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Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

Information source: West-Ward Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Phenobarbital (Drug); Placebo tablet (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: West-Ward Pharmaceutical

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency

Secondary outcome:

Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses

Assess the effects of phenobarbital on Type I seizures

Assess the safety of phenobarbital

Assess the tolerability of phenobarbital

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

Eligibility

Minimum age: 17 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Hospital Del Maestro, Hato Rey 00918, Puerto Rico

Centro Neurodiagnostico, Rio Piedras 00924, Puerto Rico

Bluegrass Epilepsy Research, Lexington, Kentucky 40504, United States

Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States

Additional Information

Starting date: November 2010
Last updated: May 27, 2014

Page last updated: August 23, 2015

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