Study of Phenobarbital Inhibition of Catamenial Epilepsy

December 9, 2014 updated by: University of Toledo Health Science Campus

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Phenobarbital - dose based by weight range
Drug: Phenobarbital
Phenobarbital will be given based on weight range
PLACEBO_COMPARATOR: 2
Placebo group
Other: Placebo
Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Screening, 3 month and final visit
Screening, 3 month and final visit
Depression Epworth Sleepiness Scale (ESS)
Time Frame: Screening, 3 month and final visit
Screening, 3 month and final visit
Quality of Life in Epilepsy (QOLIE-10)
Time Frame: Screening, 3 month and Final Visit
Screening, 3 month and Final Visit
Addenbrooke's Cognitive Examination (ACE)
Time Frame: Screening, 3 month and Final Visit
Screening, 3 month and Final Visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above
Time Frame: Screening, 3 months, final visit
Screening, 3 months, final visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toledo Health Science Campus

Investigators

  • Principal Investigator: Lazar J Greenfield, Jr, MD, PhD, University of Toledo Health Science Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ANTICIPATED)

March 1, 2009

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (ESTIMATE)

September 17, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xUTHSC-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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