Progesterone vs Placebo Therapy for Women With Epilepsy

Beth Israel Lahey Health

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Biological: Progesterone Lozenges; Other: Matched Placebo Lozenges

Study type: Interventional

Funder types: Other

Identifiers

NCT00029536

2001P001408

CRC

NINDS NS39466

Details and patient eligibility

About

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.

Full 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.

Enrollment: 294 patients

Sex: Female

Ages: 13 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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294 participants in 4 patient groups, including a placebo group

Catamenial Epilepsy: Progesterone Lozenges

Experimental group

Description:

Subjects with catamenial epilepsy received 200 mg progesterone lozenges

Treatment:

Biological: Progesterone Lozenges

Catamenial Epilepsy: Placebo Lozenges

Placebo Comparator group

Description:

Subjects with catamenial epilepsy received matched placebo lozenges

Treatment:

Other: Matched Placebo Lozenges

Noncatamenial Epilespy:Progesterone Lozenges

Experimental group

Description:

Subjects without catamenial epilepsy received 200 mg progesterone lozenges

Treatment:

Biological: Progesterone Lozenges

Noncatamenial Epilespy: Placebo Lozenges

Placebo Comparator group

Description:

Subjects without catamenial epilepsy received matched placebo lozenges

Treatment:

Other: Matched Placebo Lozenges