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Study of Phenobarbital Inhibition of Catamenial Epilepsy

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ClinicalTrials.gov Identifier: NCT00530413
Recruitment Status : Withdrawn (IRB needs updated)
First Posted : September 17, 2007
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Toledo Health Science Campus

Study Description
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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
Epilepsy Drug: Phenobarbital Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 2007
Estimated Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: Screening, 3 month and final visit ]
  2. Depression Epworth Sleepiness Scale (ESS) [ Time Frame: Screening, 3 month and final visit ]
  3. Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Screening, 3 month and Final Visit ]
  4. Addenbrooke's Cognitive Examination (ACE) [ Time Frame: Screening, 3 month and Final Visit ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530413


Locations
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United States, Ohio
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
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Principal Investigator: Lazar J Greenfield, Jr, MD, PhD University of Toledo Health Science Campus
More Information
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Responsible Party: University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT00530413    
Other Study ID Numbers: xUTHSC-07
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers