Study of Phenobarbital Inhibition of Catamenial Epilepsy

NCT00530413 | Withdrawn

• 1 other identifier: xUTHSC-07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire (PHQ-9)

  Screening, 3 month and final visit

• Depression Epworth Sleepiness Scale (ESS)

  Screening, 3 month and final visit

• Quality of Life in Epilepsy (QOLIE-10)

  Screening, 3 month and Final Visit

• Addenbrooke's Cognitive Examination (ACE)

  Screening, 3 month and Final Visit

Secondary Outcomes (1)

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

  Screening, 3 months, final visit

Study Arms (2)

1

EXPERIMENTAL

Phenobarbital - dose based by weight range

Drug: Phenobarbital

2

PLACEBO COMPARATOR

Placebo group

Other: Placebo

Interventions

Phenobarbital DRUG

Phenobarbital will be given based on weight range

1

Placebo OTHER

Placebo group

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Phenobarbital

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lazar J Greenfield, Jr, MD, PhD

  University of Toledo Health Science Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

US (1)