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Study of Phenobarbital Inhibition of Catamenial Epilepsy

Information source: University of Toledo Health Science Campus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Phenobarbital (Drug); Placebo (Other)

Phase: N/A

Status: Withdrawn

Sponsored by: University of Toledo Health Science Campus

Official(s) and/or principal investigator(s):
Lazar J Greenfield, Jr, MD, PhD, Principal Investigator, Affiliation: University of Toledo Health Science Campus

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.

Clinical Details

Official title: Study of Phenobarbital Inhibition of Catamenial Epilepsy

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

Primary outcome:

Patient Health Questionnaire (PHQ-9)

Depression Epworth Sleepiness Scale (ESS)

Quality of Life in Epilepsy (QOLIE-10)

Addenbrooke's Cognitive Examination (ACE)

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

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

University of Toledo, Health Science Campus, Toledo, Ohio 43606, United States
Additional Information

Starting date: March 2007
Last updated: December 9, 2014

Page last updated: August 23, 2015

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