Progesterone vs Placebo Therapy for Women With Epilepsy
NCT ID: NCT00029536
Last Updated: 2017-06-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
294 participants
INTERVENTIONAL
2000-10-31
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Premenstrual Dysphoric Disorder and Antiepileptic Drugs
NCT00612235
Role of Hormones in Susceptibility to Seizures in Women With Epilepsy
NCT00044252
Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures
NCT02849626
A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive
NCT00296413
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
NCT01618695
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Catamenial Epilepsy: Progesterone Lozenges
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
Progesterone Lozenges
200mg Progesterone Lozenges
Catamenial Epilepsy: Placebo Lozenges
Subjects with catamenial epilepsy received matched placebo lozenges
Matched Placebo Lozenges
Matched Placebo Lozenges
Noncatamenial Epilespy:Progesterone Lozenges
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
Progesterone Lozenges
200mg Progesterone Lozenges
Noncatamenial Epilespy: Placebo Lozenges
Subjects without catamenial epilepsy received matched placebo lozenges
Matched Placebo Lozenges
Matched Placebo Lozenges
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Progesterone Lozenges
200mg Progesterone Lozenges
Matched Placebo Lozenges
Matched Placebo Lozenges
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
13 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
Columbia University
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Emory University
OTHER
Johns Hopkins University
OTHER
Montreal Neurological Institute and Hospital
OTHER
Ohio State University
OTHER
Thomas Jefferson University
OTHER
University of Maryland
OTHER
University of Southern California
OTHER
University of Virginia
OTHER
Weill Medical College of Cornell University
OTHER
Minnesota Comprehensive Epilepsy Program
UNKNOWN
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrew Herzog
Professor of Neurology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew G Herzog, M.D., M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Southern California, Keck School of Medicine
Los Angeles, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
MINCEP Epilepsy Care
Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center
New York, New York, United States
Columbia Medical Center
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University Hospital, Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Montreal Neurological Institute
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NINDS NS39466
Identifier Type: -
Identifier Source: secondary_id
CRC
Identifier Type: -
Identifier Source: secondary_id
2001P001408
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.