drugset / Trial / NCT00029536
Progesterone vs Placebo Therapy for Women With Epilepsy
Phase 3
Completed
294 enrolled
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital · collabColumbia University · collabDartmouth-Hitchcock Medical Center · collabEmory University · collabJohns Hopkins University · collabMinnesota Comprehensive Epilepsy Program · collabMontreal Neurological Institute and Hospital · collabOhio State University · collabThomas Jefferson University · collabUniversity of Maryland · collabUniversity of Southern California · collabUniversity of Virginia · collabWeill Medical College of Cornell University · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2000-10
- Primary completion
- 2010-06
- Completion
- 2010-06
Publications
- Background 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.
- Background 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.
- Background 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 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Progesterone | Other / unclassified | 200 mg | — |