Catamenial Epilepsy Treatment

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Timothy Welty, PharmD

Criteria

Inclusion Criteria

1. Female with a positive diagnosis of epilepsy, and

2. Women with epilepsy (WWE) patients who have seizures and treated with AEDs and no dosage changes in the past 30 days, and

3. WWE patients with regular menstrual period with range of 28 ± 7 days.

4. WWE patients with age range between 21 and 45 years old.

5. WWE patients who are willing and able to give signed informed consent form are eligible to participate in this study.

6. WWE who agree to use non-hormonal forms of contraception for the duration of this study.

No hormonal Intra-Uterine Device is allowed for the duration of this study.

7. Patients with a history of cancer must be in remission for at least 5 years.

Exclusion Criteria

1. History of status epilepticus in the last 12 months

2. Current diagnosis of polycystic ovary syndrome and/or endometriosis

3. Pregnant or breast feeding

4. Allergy to any ingredients in KBG (cinnamon, hoelen, moutan bark, peony root, or peach kernel)

5. Patients who are receiving warfarin and/or antiplatelet drugs

6. Severe cardiovascular, renal or hepatic impairment (i.e., coronary heart disease, myocardial infarction, renal failure, hepatitis) or history of those diseases

7. Any other unstable diseases (e.g., mental disease, infection, cancer)

8. Lab values at screening phase showing 1.5 times above the upper range of normal

9. Patients who are receiving phenytoin will be excluded (since a potential interaction between phenytoin and peony root was reported)