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Study of Phenobarbital Inhibition of Catamenial Epilepsy

Primary Purpose

Epilepsy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phenobarbital
Placebo
Sponsored by
University of Toledo Health Science Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Toledo, Health Science Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Phenobarbital - dose based by weight range

Placebo group

Outcomes

Primary Outcome Measures

Patient Health Questionnaire (PHQ-9)
Depression Epworth Sleepiness Scale (ESS)
Quality of Life in Epilepsy (QOLIE-10)
Addenbrooke's Cognitive Examination (ACE)

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2007
Last Updated
December 9, 2014
Sponsor
University of Toledo Health Science Campus
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1. Study Identification

Unique Protocol Identification Number
NCT00530413
Brief Title
Study of Phenobarbital Inhibition of Catamenial Epilepsy
Official Title
Study of Phenobarbital Inhibition of Catamenial Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
IRB needs updated
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Phenobarbital - dose based by weight range
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Drug
Intervention Name(s)
Phenobarbital
Intervention Description
Phenobarbital will be given based on weight range
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo group
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Time Frame
Screening, 3 month and final visit
Title
Depression Epworth Sleepiness Scale (ESS)
Time Frame
Screening, 3 month and final visit
Title
Quality of Life in Epilepsy (QOLIE-10)
Time Frame
Screening, 3 month and Final Visit
Title
Addenbrooke's Cognitive Examination (ACE)
Time Frame
Screening, 3 month and Final Visit
Secondary Outcome Measure Information:
Title
Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above
Time Frame
Screening, 3 months, final visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lazar J Greenfield, Jr, MD, PhD
Organizational Affiliation
University of Toledo Health Science Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo, Health Science Campus
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States

12. IPD Sharing Statement

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Study of Phenobarbital Inhibition of Catamenial Epilepsy

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