Study of Phenobarbital Inhibition of Catamenial Epilepsy

This study is currently recruiting participants.

Verified by University of Toledo Health Science Campus, September 2007

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

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

MedlinePlus related topics: Depression Epilepsy Seizures

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:

Log of the their menstrual cycles and seizures Progesterone levels [ Time Frame: Monthly ]
Patient Health Questionnaire (PHQ-9) [ Time Frame: Screening, 3 month and final visit ]
Depression Epworth Sleepiness Scale (ESS) [ Time Frame: Screening, 3 month and final visit ]
Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Screening, 3 month and Final Visit ]
Addenbrooke's Cognitive Examination (ACE) [ Time Frame: Screening, 3 month and Final Visit ]

Secondary Outcome Measures:

Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above

Estimated Enrollment:	100
Study Start Date:	September 2007

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 benzodiazapenes 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 preceeding 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

Contacts

Contact: Lazar J Greenfield, Jr, MD, PhD	419-383-3856	jgreenfield@meduohio.edu
Contact: Kimberly Wilson		kwilson4@meduohio.edu

Locations

United States, Ohio
University of Toledo, Health Science Campus	Recruiting
Toledo, Ohio, United States, 43606
Contact: Lazar J Greenfiled, Jr, MD, PhD 419-383-3856 jgreenfield@meduohio.edu

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

Study ID Numbers:	UTHSC-07
Study First Received:	September 13, 2007
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00530413
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Excitatory Amino Acids
Phenobarbital
Epilepsy
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on January 16, 2009