Recruiting
Phase 2

Catamenial Epilepsy

Sponsor:

Timothy Welty, PharmD

Code:

NCT01299870

Conditions

Epilepsy

Eligibility Criteria

Sex: Female

Age: 21 - 45

Healthy Volunteers: Not accepted

Interventions

AED treatment plus placebo

Keishibukuryogan

Study Details

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.

Conditions

Epilepsy

Study ID

NCT01299870

Start date

Feb, 2011

Status verified date

Feb, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 45

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

17 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: AED treatment plus placebo

experimental: Keishibukuryogan

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.

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.

Primary outcome measure

  • To determine if Keishibukuryogan is safe for WWE [ Time Frame: up to 36 weeks ]

Central Contacts and Locations

Central contacts

Mikiko Yamada, Pharm D

913-588-9829myamada@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Mikiko Yamada, Pharm D

913-588-9829myamada@kumc.edu

Principal Investigator:

Timothy Welty, Pharm D

More Information

Sponsor

Timothy Welty, PharmD

Last update posted

Feb 14, 2012

Last verified

Feb, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Timothy Welty, PharmD on 2012-02-14.