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Study of Phenobarbital Inhibition of Catamenial Epilepsy

Sponsor
University of Toledo Health Science Campus (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00530413
Collaborator
(none)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Study of Phenobarbital Inhibition of Catamenial Epilepsy
Study Start Date :
Mar 1, 2007
Anticipated Primary Completion Date :
Mar 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire (PHQ-9) [Screening, 3 month and final visit]

  2. Depression Epworth Sleepiness Scale (ESS) [Screening, 3 month and final visit]

  3. Quality of Life in Epilepsy (QOLIE-10) [Screening, 3 month and Final Visit]

  4. Addenbrooke's Cognitive Examination (ACE) [Screening, 3 month and Final Visit]

Secondary Outcome Measures

  1. Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above [Screening, 3 months, final visit]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT00530413
Other Study ID Numbers:
  • xUTHSC-07
First Posted:
Sep 17, 2007
Last Update Posted:
Dec 10, 2014
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:
Epilepsy
Phenobarbital

Study Results

No Results Posted as of Dec 10, 2014