Catamenial Epilepsy Treatment

NCT ID: NCT01299870

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-12-31

Brief 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.

Detailed Description

It is known that the female hormone levels in epilepsy patients are different from healthy women. These hormonal differences may be part of the cause of catamenial epilepsy. It is estimated that at least 1 in every 3 women with epilepsy have catamenial epilepsy. Although many antiepileptic drugs are available, it is very difficult to control these seizures. In the past, studies using antiepileptic drugs and hormonal agents were done to treat catamenial epilepsy. However, those medications did not work well and caused side effects.

Keishibukuryogan is a traditional Japanese herbal medication. It is made of 5 natural herbs (cinnamon bark, hoelen, moutan bark, peony root, and peach kernel). It is used to treat disorders in women like menopause and menstrual cycle problems. This is the first study to examine the safety of Keishibukuryogan in women with epilepsy. As such, Keishibukuryogan and your current antiepileptic drug(s) will be given to you during the study.

Keishibukuryogan is a dietary supplement in the United States. It can be bought without a prescription. The safety and efficacy of Keishibukuryogan has not been studied in epilepsy. However, it has been used safely in Japan and other Asian countries for years.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AED treatment plus placebo

Group Type: ACTIVE_COMPARATOR

AED treatment plus placebo

Intervention Type: DRUG

Your usual AED(s) treatment with placebo for 12 weeks followed by 4 weeks washout period, and then Keishibukuryogan, (2.5 g of granulate filled in capsules) three times a day for a total of 7.5 g a day with your usual AED(s) treatment for 12 weeks.

Keishibukuryogan

Group Type: EXPERIMENTAL

Keishibukuryogan

Intervention Type: DRUG

Keishibukuryogan, (2.5 g of granulate filled in capsules) three times a day for a total of 7.5 g a day with your usual AED(s) for 12 weeks followed by 4 weeks washout period, and then your usual AED(s) treatment with placebo for 12 weeks.

Interventions

AED treatment plus placebo

Your usual AED(s) treatment with placebo for 12 weeks followed by 4 weeks washout period, and then Keishibukuryogan, (2.5 g of granulate filled in capsules) three times a day for a total of 7.5 g a day with your usual AED(s) treatment for 12 weeks.

Intervention Type: DRUG

Keishibukuryogan

Keishibukuryogan, (2.5 g of granulate filled in capsules) three times a day for a total of 7.5 g a day with your usual AED(s) for 12 weeks followed by 4 weeks washout period, and then your usual AED(s) treatment with placebo for 12 weeks.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Timothy Welty, PharmD

OTHER

Sponsor Role: lead

Responsible Party

Timothy Welty, PharmD

Professor and Chair of Pharmacy Practice

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Timothy Welty, Pharm D

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mikiko Yamada, Pharm D

Role: CONTACT

myamada@kumc.edu

913-588-9829

Facility Contacts

Mikiko Yamada, Pharm D

Role: primary

myamada@kumc.edu

913-588-9829

Other Identifiers

12416

Identifier Type: -

Identifier Source: org_study_id