Skip to main content
OpenTrials
Completed

NCT Number: NCT00029536

Progesterone vs Placebo Therapy for Women With Epilepsy

The purpose of this investigation was to determine if cyclic adjunctive progesterone supplement is superior to placebo in the treatment of intractable seizures in women with and without catamenial epilepsy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

13 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Montreal Neurological Institute, Montreal, Quebec, Canada

Loading trial locations.

About this study

This is a 6-month study. The first 3 months will gather baseline information on seizures, antiepileptic drug levels , menstrual cycles, hormone levels, emotional function, and quality of life. The second 3 months will assess the effects of treatment on these parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION:

  • Subject must be between the ages of 13 and 45.
  • Subject must have a history of seizures (documented by EEG).
  • Subject must have had at least 2 seizures or auras per month during the past 3 months.
  • Subject must be on stable antiepileptic drug therapy for at least 2 months.
  • Subject must have cycle intervals between 21 and 35 days during 6 months prior to entry.

EXCLUSION:

  • Subject that is pregnant or lactating.
  • Subject that is on major tranquilizers, antidepressant medications, or reproductive hormones.
  • Subject that is unable to document seizures.
  • Subject that has progressive neurological or systemic disorder or > 2-fold elevation in liver enzyme levels

Treatment and study plan

Progesterone Lozenges

Biological

200mg Progesterone Lozenges

Matched Placebo Lozenges

Other

Matched Placebo Lozenges

Primary outcomes

  1. Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency

    Time frame: 9 years

    Percent of women who show a greater than 50% decline in average daily seizure frequency

Secondary outcomes

  1. Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.

    Time frame: 9 years

    Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.

  2. Percentage of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency for Secondary Generalized, Complex Partial and Simple Partial Seizures Considered Separately

    Time frame: 9 years

    Percentage of women who show a greater than 50% decline in average daily seizure frequency for secondary generalized, complex partial and simple partial seizures considered separately

  3. Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.

    Time frame: 9 years

    Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.

  4. Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.

    Time frame: 9 years

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Brigham and Women's Hospital
  • Columbia University
  • Dartmouth-Hitchcock Medical Center
  • Emory University
  • Johns Hopkins University
  • Minnesota Comprehensive Epilepsy Program
  • Montreal Neurological Institute and Hospital
  • Ohio State University
  • Thomas Jefferson University
  • University of Maryland
  • University of Southern California
  • University of Virginia
  • Weill Medical College of Cornell University

Registry information

Official study title

Phase 3 Study of Progesterone vs Placebo Therapy

Important dates

Study start
2000
Primary completion
2010
Study completion
2010
First posted
Jan 16, 2002
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.