Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures - Full Text View

Purpose

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.

Condition	Intervention	Phase
Epilepsy	Drug: Phenobarbital Drug: Placebo tablet	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Phenobarbital Phenobarbital sodium

U.S. FDA Resources

Further study details as provided by West-Ward Pharmaceutical:

Primary Outcome Measures:

Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency [ Time Frame: 34 weeks with maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]
- 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

Secondary Outcome Measures:

Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses [ Time Frame: 34 weeks with a maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]
Assess the effects of phenobarbital on Type I seizures [ Time Frame: 34 weeks with a maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]
- seizure freedom rate
- percent reduction for partial onset seizure
- responder rate
- reduction of seizure frequency
Assess the safety of phenobarbital [ Time Frame: 34 weeks with a maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]
- 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
Assess the tolerability of phenobarbital [ Time Frame: 34 weeks with maximum 22-week exposure to phenobarbital ] [ Designated as safety issue: No ]

Estimated Enrollment:	345
Study Start Date:	November 2010
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo placebo tablets	Drug: Placebo tablet tablet
Experimental: 60 mg group	Drug: Phenobarbital tablet
Experimental: 100 mg group	Drug: Phenobarbital tablet

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

Ages Eligible for Study:	17 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284556

Locations

United States, Kentucky
Bluegrass Epilepsy Research	Recruiting
Lexington, Kentucky, United States, 40504
Contact: Amber Chumley 859-313-4989
Principal Investigator: Toufic Fakhoury, MD
United States, New Jersey
Northeast Regional Epilepsy Group	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Sarah Henry 201-343-6676
Principal Investigator: Evan Fertig, MD
United States, Oklahoma
Lynn Health Science Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Michael Thomas 405-602-3927
Principal Investigator: Mark Fisher, MD
Sub-Investigator: Carl Griffen, MD
Sub-Investigator: Surinder Randhawa, MD
Puerto Rico
Hospital Del Maestro	Recruiting
Hato Rey, Puerto Rico, 00918
Contact: Julio Ramos, RN 787-765-3490
Principal Investigator: Louis P Sanchez Longo, MD
Centro Neurodiagnostico	Recruiting
Rio Piedras, Puerto Rico, 00924
Contact: Rosario Perez Gatell 787-751-5945
Principal Investigator: Norma Agosto- Maury, MD

Sponsors and Collaborators

West-Ward Pharmaceutical

More Information

No publications provided

Responsible Party:	Loren Gelber, PhD Chief Scientific Officer, RRI Group Inc
ClinicalTrials.gov Identifier:	NCT01284556 History of Changes
Other Study ID Numbers:	AGG-901, 2010-020871-22
Study First Received:	January 20, 2011
Last Updated:	January 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by West-Ward Pharmaceutical:

partial onset seizures

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Phenobarbital
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Anticonvulsants

ClinicalTrials.gov processed this record on June 17, 2013