Clinical trial NCT00029536: Progesterone vs Placebo Therapy for Women With Epilepsy
Official title: Phase 3 Study of Progesterone vs Placebo Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Seizure
Hormone
Progesterone
Catamenial
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Columbia University
name: Dartmouth-Hitchcock Medical Center
name: Emory University
name: Johns Hopkins University
name: Montreal Neurological Institute and Hospital
name: Ohio State University
name: Thomas Jefferson University
name: University of Maryland
name: University of Southern California
name: University of Virginia
name: Weill Medical College of Cornell University
name: Minnesota Comprehensive Epilepsy Program
First posted: 2002-01-16
Enrollment: 294
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Randomization was carried out separately for women with and without catamenial epilepsy, 2:1 to progesterone or placebo.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: INCLUSION:

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

EXCLUSION:

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

Primary outcomes:
measure: Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency
timeFrame: 9 years
Secondary outcomes:
measure: Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.
timeFrame: 9 years
measure: 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
timeFrame: 9 years
measure: Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.
timeFrame: 9 years
measure: Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.
timeFrame: 9 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California, Keck School of Medicine
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: MINCEP Epilepsy Care
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center
state: New York
city: New York
country: United States
facility: Columbia Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital, Comprehensive Epilepsy Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Montreal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Andrew G Herzog, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herzog AG. Progesterone therapy in women with complex partial and secondary generalized seizures. Neurology. 1995 Sep;45(9):1660-2. doi: 10.1212/wnl.45.9.1660.
citation: Herzog AG. Progesterone therapy in women with epilepsy: a 3-year follow-up. Neurology. 1999 Jun 10;52(9):1917-8. doi: 10.1212/wnl.52.9.1917-a. No abstract available.
citation: Herzog AG, Klein P, Ransil BJ. Three patterns of catamenial epilepsy. Epilepsia. 1997 Oct;38(10):1082-8. doi: 10.1111/j.1528-1157.1997.tb01197.x.
citation: Herzog AG, Harden CL, Liporace J, Pennell P, Schomer DL, Sperling M, Fowler K, Nikolov B, Shuman S, Newman M. Frequency of catamenial seizure exacerbation in women with localization-related epilepsy. Ann Neurol. 2004 Sep;56(3):431-4. doi: 10.1002/ana.20214.
citation: Maguire MJ, Nevitt SJ. Treatments for seizures in catamenial (menstrual-related) epilepsy. Cochrane Database Syst Rev. 2021 Sep 16;9(9):CD013225. doi: 10.1002/14651858.CD013225.pub3.