Study of Phenobarbital Inhibition of Catamenial Epilepsy

Epilepsy Clinical Trial

Official title:

Study of Phenobarbital Inhibition of Catamenial Epilepsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00530413
• Other study ID #: xUTHSC-07
• Status: Withdrawn
• Phase: N/A
• First received: September 13, 2007
• Last updated: December 9, 2014
• Start date: March 2007

Study information

• Verified date: December 2014
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Phenobarbital
Phenobarbital will be given based on weight range

Other:
• Placebo
Placebo group

Locations

Country	Name	City	State
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9)		Screening, 3 month and final visit	No
Primary	Depression Epworth Sleepiness Scale (ESS)		Screening, 3 month and final visit	No
Primary	Quality of Life in Epilepsy (QOLIE-10)		Screening, 3 month and Final Visit	No
Primary	Addenbrooke's Cognitive Examination (ACE)		Screening, 3 month and Final Visit	No
Secondary	Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above		Screening, 3 months, final visit	No