drugset / Trial / NCT01299870

Catamenial Epilepsy Treatment

NCT01299870 ↗

Phase 2 Unknown 17 enrolled Timothy Welty, PharmD
RandomizedCrossoverDouble-blindTreatment

Summary

Epilepsy is a disorder in the brain. The brain is full of "nerve" cells. Nerve cells have normal electrical activity to control the many functions of the body. Sometimes nerve cells do not function normally due to many different reasons such as disease, an injury or because the brain didn't develop normally at birth. When nerve cells do not function normally the electrical activity that controls things like muscles and body movement can get mixed up and cause seizures. When a seizure occurs, sometimes a person loses control of body movement, and/or bodily functions. When a seizure occurs, a person may become unconscious, and/or senses may be affected. Seizures can occur at any time, without warning, and can lead to many health problems. "Catamenial epilepsy" is specific form of epilepsy in women. It is closely related to the menstrual cycle. In this form of epilepsy seizures increase around the menstrual period. By doing this study, researchers hope to learn whether Keishibukuryogan add-on therapy with antiepileptic drugs is safe for women with epilepsy.

Timeline

Start
2011-02
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Keishibukuryogan Traditional medicine (herbal / TCM) 2.5 g —

Indications