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Catamenial Epilepsy Treatment

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AED treatment plus placebo
Keishibukuryogan
Sponsored by
Timothy Welty, PharmD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

AED treatment plus placebo

Keishibukuryogan

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 16, 2011
Last Updated
February 13, 2012
Sponsor
Timothy Welty, PharmD
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1. Study Identification

Unique Protocol Identification Number
NCT01299870
Brief Title
Catamenial Epilepsy Treatment
Official Title
Keishibukuryogan (Japanese Herbal Supplement) for the Adjunctive Treatment of Catamenial Epilepsy in Adult: Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Timothy Welty, PharmD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AED treatment plus placebo
Arm Type
Active Comparator
Arm Title
Keishibukuryogan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AED treatment plus placebo
Intervention Description
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
Intervention Name(s)
Keishibukuryogan
Intervention Description
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 Information:
Title
To determine if Keishibukuryogan is safe for WWE
Description
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).
Time Frame
up to 36 weeks
Secondary Outcome Measure Information:
Title
To determine if KBG changes seizure frequency in WWE, with a focus on increases in seizure frequency.
Description
Based on the basic animal data, KBG has antiepileptic properties and may be beneficial for WWE.
Time Frame
up to 36 weeks
Title
To determine if KBG alters progesterone levels in WWE.
Description
Based on the basic animal data, KBG altered serum progesterone level. Therefore, we would like to examine how KBG affects serum progesterone level.
Time Frame
up to 36 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikiko Yamada, Pharm D
Phone
913-588-9829
Email
myamada@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Welty, Pharm D
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Yamada, Pharm D
Phone
913-588-9829
Email
myamada@kumc.edu
First Name & Middle Initial & Last Name & Degree
Timothy Welty, Pharm D

12. IPD Sharing Statement

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Catamenial Epilepsy Treatment

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