Study of Phenobarbital Inhibition of Catamenial Epilepsy - Full Text View

Sponsored by:	University of Toledo Health Science Campus
Information provided by:	University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:	NCT00530413

Purpose

The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy.

We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital will reduce the incidence of catamenial seizures.

Condition	Intervention
Epilepsy	Drug: Phenobarbital Other: Placebo

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

MedlinePlus related topics: Depression Epilepsy

Drug Information available for: Phenobarbital Phenobarbital sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	Study of Phenobarbital Inhibition of Catamenial Epilepsy

Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:

Patient Health Questionnaire (PHQ-9) [ Time Frame: Screening, 3 month and final visit ] [ Designated as safety issue: No ]
Depression Epworth Sleepiness Scale (ESS) [ Time Frame: Screening, 3 month and final visit ] [ Designated as safety issue: No ]
Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Screening, 3 month and Final Visit ] [ Designated as safety issue: No ]
Addenbrooke's Cognitive Examination (ACE) [ Time Frame: Screening, 3 month and Final Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above [ Time Frame: Screening, 3 months, final visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Phenobarbital - dose based by weight range	Drug: Phenobarbital Phenobarbital will be given based on weight range
2: Placebo Comparator Placebo group	Other: Placebo Placebo group

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult female patients seeking medical attention for seizures
Regular menstrual cycles
At least 2 seizures per month
Must be on at least one form of birth control other than abstinence
Must be on a stable anticonvulsant regimen of at least one and not exceeding three anticonvulsants, and not be using any perimenstrual seizure medications of hormone preparations
If taking benzodiazepines for therapeutic purposes, must be on a stable regular dose
Must be willing to take at least 400mcg of folic acid a day while in the study
Must be able to detect, count or record seizures

Exclusion Criteria:

Can not be pregnant or trying to become pregnant
Can not have used hormonal birth control methods for at least 3 months prior to enrollment
Can not have an allergy to Phenobarbital
Can not have a history of non-epileptic seizures
Can not have a know liver dysfunction or history of chronic hepatitis
Can not have a history of neurological disorder or history of status epilepticus in the preceding year
Can not ahve a physical or psychiatric condition which in the PIs opinion could compromise her ability to participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530413

Locations

United States, Ohio
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43606

Sponsors and Collaborators

University of Toledo Health Science Campus

Investigators

Principal Investigator:

Lazar J Greenfield, Jr, MD, PhD

University of Toledo Health Science Campus

More Information

No publications provided

Responsible Party:	University of Toledo HSC ( Lazar Greenfield, Jr )
Study ID Numbers:	UTHSC-07
Study First Received:	September 13, 2007
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00530413 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Excitatory Amino Acids
Neurotransmitter Agents
Phenobarbital
Epilepsy
Hypnotics and Sedatives

Central Nervous System Depressants
Central Nervous System Diseases
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Phenobarbital
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Central Nervous System Depressants
Excitatory Amino Acid Agents

Brain Diseases
Pharmacologic Actions
Epilepsy
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 07, 2009