EpilepsyPhase 2NCT01299870
Catamenial Epilepsy Treatment
A Phase 2 study testing Keishibukuryogan in people with Epilepsy, run by Timothy Welty, PharmD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Epilepsy
- What is being tested?
- Keishibukuryogan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Mikiko Yamada, Pharm D, 913-588-9829, myamada@kumc.edu
Timothy Welty, Pharm D
About this study
Official title: Keishibukuryogan (Japanese Herbal Supplement) for the Adjunctive Treatment of Catamenial Epilepsy in Adult: Safety Study
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.
Read the 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
- Being tested
- AED treatment plus placebo, Keishibukuryogan
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AED treatment plus placeboDrug
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.
KeishibukuryoganDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| AED treatment plus placebo | Active comparator | Not described Receives: Drug: AED treatment plus placebo |
| Keishibukuryogan | Experimental | Not described Receives: Drug: Keishibukuryogan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 36 weeks
Secondary outcomes (2)
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.
Measured: up to 36 weeks
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.
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Timothy Welty, PharmD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Welty, PharmD, University of Kansas Medical Center
- Investigators
- Timothy Welty, Pharm D, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299870
- Sponsor's protocol ID
- 12416
- Status last verified
- Feb 2012
- First submitted
- 16 Feb 2011
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keishibukuryogan (Japanese Herbal Supplement) for the Adjunctive Treatment of Catamenial Epilepsy in Adult: Safety Study
- ClinicalTrials.gov ID
- NCT01299870
- Acronym / sponsor ID
- 12416
- Conditions
- Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Timothy Welty, PharmDUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AED treatment plus placebo | Active comparator | Drug: AED treatment plus placebo |
| Keishibukuryogan | Experimental | Drug: Keishibukuryogan |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AED treatment plus placeboYour 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. | Drug | AED treatment plus placebo |
| KeishibukuryoganKeishibukuryogan, (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. | Drug | Keishibukuryogan |
Primary outcome
To determine if Keishibukuryogan is safe for WWE
Time frame: up to 36 weeks
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).
2 secondary outcomes
To determine if KBG changes seizure frequency in WWE, with a focus on increases in seizure frequency.
Time frame: up to 36 weeks
To determine if KBG alters progesterone levels in WWE.
Time frame: up to 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Welty, Pharm D principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Keishibukuryogan in people with Epilepsy, run by Timothy Welty, PharmD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikiko Yamada, Pharm D (913-588-9829, myamada@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if Keishibukuryogan is safe for WWE (time frame: up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.