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Progesterone vs Placebo Therapy for Women With Epilepsy

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Progesterone Lozenges
Matched Placebo Lozenges
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Seizure, Hormone, Progesterone, Catamenial

Eligibility Criteria

13 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California, Keck School of Medicine
  • Emory University School of Medicine
  • University of Maryland
  • Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit
  • Henry Ford Hospital
  • MINCEP Epilepsy Care
  • Dartmouth-Hitchcock Medical Center
  • New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center
  • Columbia Medical Center
  • Ohio State University
  • Thomas Jefferson University Hospital, Comprehensive Epilepsy Center
  • University of Virginia
  • Montreal Neurological Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Catamenial Epilepsy: Progesterone Lozenges

Catamenial Epilepsy: Placebo Lozenges

Noncatamenial Epilespy:Progesterone Lozenges

Noncatamenial Epilespy: Placebo Lozenges

Arm Description

Subjects with catamenial epilepsy received 200 mg progesterone lozenges

Subjects with catamenial epilepsy received matched placebo lozenges

Subjects without catamenial epilepsy received 200 mg progesterone lozenges

Subjects without catamenial epilepsy received matched placebo lozenges

Outcomes

Primary Outcome Measures

Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency
Percent of women who show a greater than 50% decline in average daily seizure frequency

Secondary Outcome Measures

Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.
Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.
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
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
Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.
Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.
Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.

Full Information

First Posted
January 15, 2002
Last Updated
June 2, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Brigham and Women's Hospital, Columbia University, Dartmouth-Hitchcock Medical Center, Emory University, Johns Hopkins University, 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, Minnesota Comprehensive Epilepsy Program
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1. Study Identification

Unique Protocol Identification Number
NCT00029536
Brief Title
Progesterone vs Placebo Therapy for Women With Epilepsy
Official Title
Phase 3 Study of Progesterone vs Placebo Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Brigham and Women's Hospital, Columbia University, Dartmouth-Hitchcock Medical Center, Emory University, Johns Hopkins University, 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, Minnesota Comprehensive Epilepsy Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Seizure, Hormone, Progesterone, Catamenial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catamenial Epilepsy: Progesterone Lozenges
Arm Type
Experimental
Arm Description
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
Arm Title
Catamenial Epilepsy: Placebo Lozenges
Arm Type
Placebo Comparator
Arm Description
Subjects with catamenial epilepsy received matched placebo lozenges
Arm Title
Noncatamenial Epilespy:Progesterone Lozenges
Arm Type
Experimental
Arm Description
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
Arm Title
Noncatamenial Epilespy: Placebo Lozenges
Arm Type
Placebo Comparator
Arm Description
Subjects without catamenial epilepsy received matched placebo lozenges
Intervention Type
Biological
Intervention Name(s)
Progesterone Lozenges
Intervention Description
200mg Progesterone Lozenges
Intervention Type
Other
Intervention Name(s)
Matched Placebo Lozenges
Intervention Description
Matched Placebo Lozenges
Primary Outcome Measure Information:
Title
Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency
Description
Percent of women who show a greater than 50% decline in average daily seizure frequency
Time Frame
9 years
Secondary Outcome Measure Information:
Title
Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.
Description
Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.
Time Frame
9 years
Title
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
Description
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
Title
Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.
Description
Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.
Time Frame
9 years
Title
Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.
Time Frame
9 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew G Herzog, M.D., M.Sc.
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California, Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
MINCEP Epilepsy Care
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson University Hospital, Comprehensive Epilepsy Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Montreal Neurological Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
7675223
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.
Results Reference
background
PubMed Identifier
10371551
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.
Results Reference
background
PubMed Identifier
9579954
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.
Results Reference
background
PubMed Identifier
15349872
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.
Results Reference
result
PubMed Identifier
34528245
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.
Results Reference
derived

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Progesterone vs Placebo Therapy for Women With Epilepsy

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