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Study of Phenobarbital Inhibition of Catamenial Epilepsy

This study has been withdrawn prior to enrollment.
(IRB needs updated)
Sponsor:
Information provided by:
University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT00530413
First received: September 13, 2007
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention
Epilepsy
Drug: Phenobarbital
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Phenobarbital Inhibition of Catamenial Epilepsy

Resource links provided by NLM:


Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Screening, 3 month and final visit ] [ Designated as safety issue: No ]
  • Depression Epworth Sleepiness Scale (ESS) [ Time Frame: Screening, 3 month and final visit ] [ Designated as safety issue: No ]
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Screening, 3 month and Final Visit ] [ Designated as safety issue: No ]
  • Addenbrooke's Cognitive Examination (ACE) [ Time Frame: Screening, 3 month and Final Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above [ Time Frame: Screening, 3 months, final visit ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2007
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530413

Locations
United States, Ohio
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
  More Information

No publications provided

Responsible Party: Lazar Greenfield, Jr, University of Toledo HSC
ClinicalTrials.gov Identifier: NCT00530413     History of Changes
Other Study ID Numbers: UTHSC-07
Study First Received: September 13, 2007
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Phenobarbital
Anticonvulsants
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014