NCT01299870

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

Status unknown Phase 2 Last updated 13 February 2012

What this trial tests

Phase 2 trial testing AED treatment plus placebo in Epilepsy in 17 participants. Status unknown.

Timeline

1 February 2011

Primary endpoint
1 December 2012

1 December 2012

Quick facts

Lead sponsor	Timothy Welty, PharmD
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	17
Start date	1 February 2011
Primary completion	1 December 2012
Estimated completion	1 December 2012
Sites	1 location across United States

Drugs / interventions tested

• AED treatment plus placebo — full drug profile →
• Keishibukuryogan — full drug profile →

Conditions studied

• Epilepsy — all drugs for Epilepsy →

Sponsor

Timothy Welty, PharmD — full company profile →

Who can join

Adults 21 to 45, female only, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatments for seizures in catamenial (menstrual-related) epilepsy.
   Maguire MJ, Nevitt SJ. · · 2019 · cited 10× · PMID 31608992 · DOI 10.1002/14651858.cd013225.pub2
2. Treatments for seizures in catamenial (menstrual-related) epilepsy.
   Maguire MJ, Nevitt SJ. · · 2021 · cited 6× · PMID 34528245 · DOI 10.1002/14651858.cd013225.pub3