Catamenial Epilepsy Treatment
Keishibukuryogan (Japanese Herbal Supplement) for the Adjunctive Treatment of Catamenial Epilepsy in Adult: Safety Study
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 14, 2012
February 1, 2012
1.8 years
February 16, 2011
February 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
To determine if KBG changes seizure frequency in WWE, with a focus on increases in seizure frequency.
up to 36 weeks
To determine if KBG alters progesterone levels in WWE.
up to 36 weeks
Study Arms (2)
AED treatment plus placebo
ACTIVE COMPARATORKeishibukuryogan
EXPERIMENTALInterventions
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, (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.
Eligibility Criteria
You may qualify if:
- Female with a positive diagnosis of epilepsy, and
- Women with epilepsy (WWE) patients who have seizures and treated with AEDs and no dosage changes in the past 30 days, and
- WWE patients with regular menstrual period with range of 28 ± 7 days.
- WWE patients with age range between 21 and 45 years old.
- WWE patients who are willing and able to give signed informed consent form are eligible to participate in this study.
- 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.
- Patients with a history of cancer must be in remission for at least 5 years.
You may not qualify if:
- History of status epilepticus in the last 12 months
- Current diagnosis of polycystic ovary syndrome and/or endometriosis
- Pregnant or breast feeding
- Allergy to any ingredients in KBG (cinnamon, hoelen, moutan bark, peony root, or peach kernel)
- Patients who are receiving warfarin and/or antiplatelet drugs
- Severe cardiovascular, renal or hepatic impairment (i.e., coronary heart disease, myocardial infarction, renal failure, hepatitis) or history of those diseases
- Any other unstable diseases (e.g., mental disease, infection, cancer)
- Lab values at screening phase showing 1.5 times above the upper range of normal
- Patients who are receiving phenytoin will be excluded (since a potential interaction between phenytoin and peony root was reported)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Welty, Pharm D
University of Kansas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor and Chair of Pharmacy Practice
Study Record Dates
First Submitted
February 16, 2011
First Posted
February 18, 2011
Study Start
February 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 14, 2012
Record last verified: 2012-02