Catamenial Epilepsy Treatment

Epilepsy Clinical Trial

Official title:

Keishibukuryogan (Japanese Herbal Supplement) for the Adjunctive Treatment of Catamenial Epilepsy in Adult: Safety Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01299870
• Other study ID #: 12416
• Status: Unknown status
• Phase: Phase 2
• First received: February 16, 2011
• Last updated: February 13, 2012
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: University of Kansas Medical Center
• Contact: Mikiko Yamada, Pharm D
• Phone: 913-588-9829
• Email: myamada[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 17
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Timothy Welty, PharmD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if Keishibukuryogan is safe for WWE	Keishibukuryogan is commonly used in Japan, but has not been formally studied in people with epilepsy. This study is designed to determine if KBG is safe to use in women with epilepsy (no increase of seizure and no adverse reactions).	up to 36 weeks
Secondary	To determine if KBG changes seizure frequency in WWE, with a focus on increases in seizure frequency.	Based on the basic animal data, KBG has antiepileptic properties and may be beneficial for WWE.	up to 36 weeks
Secondary	To determine if KBG alters progesterone levels in WWE.	Based on the basic animal data, KBG altered serum progesterone level. Therefore, we would like to examine how KBG affects serum progesterone level.	up to 36 weeks