Phase 3
Completed N=294
Progesterone vs Placebo Therapy for Women With Epilepsy
Source: ClinicalTrials.gov NCT00029536 ↗Enrolled (actual)
294
Serious AEs
3.1%
Results posted
Jun 2017
Primary outcomePrimary: Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency — 22.8; 20.0; 20.2; 19.2 percentage of participants
◆ Published Evidence
Highly cited
156citations · ~7 / year
Frequency of catamenial seizure exacerbation in women with localization-related epilepsy.
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.
Linked Publications (2)
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Frequency of catamenial seizure exacerbation in women with localization-related epilepsy.
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Treatments for seizures in catamenial (menstrual-related) epilepsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency |
22.8; 20.0; 20.2; 19.2 | — |
| SECONDARY Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type. |
30.4; 24.4; 22.2; 28.8 | — |
| SECONDARY 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 |
39.39; 29.41; 21.21; 20.83; 23.68; 18.60 | — |
| SECONDARY Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment. |
9.8; 9.1; 10.8; 9.1; 44.4; 9.2 | — |
| SECONDARY Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy. |
8.9; 9.6; 23.2; 22.6; 11.1; 8.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT00029536) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.