A single-center, randomized, placebo-controlled, 10-month trial to predict the treatment response to Clobazam in catamenial epilepsy.

2013-9490
Seizures, Epilepsy
Mona Sazgar, MD
The University of California, Irvine in Irvine, CA
You are being asked to take part in this research study because you have catamenial epilepsy. Catamenial epilepsy is a type of epilepsy when seizures become more intense or happen more frequently at certain days of a woman’s menstrual cycle. The purpose of this study is to see if there are predictors for treatment response to Clobazam. More specifically, the research team wants to see if these predictors show up on brain scans. Researchers have been able to identify hallmark characteristics in the brains of people with diseases such as Alzheimer’s disease and depression. If the researchers can identify these biomarkers, it may allow them to identify who may or may not respond to Clobazam.
You can participate in this study if you: 

Are a woman aged 15 through 45, weighing at least 30 kg, who has:

  • Been diagnosed with partial epilepsy for at least 1 year
  • At least 3 seizures per month
  • Continued to have seizures over the past 6 months despite being on 2 or more seizure medications
  • Seizures that worsen at or around their time of menstruation
  • Been on the same seizure medication regimen for at least one month
  • Documented normal liver enzymes at study onset
  • Vagal nerve stimulator (VNS) settings that have not changed for at least one month
  • Regular (26 to 32 day) menstrual cycles for at least 6 months
  • Willing to use a method of birth control such as intrauterine devices, diaphragm, foam, or condom if sexually active 
  • Able to cooperate with MRI studies 
  • Able to keep a seizure & medication diary throughout the course of the study 
You cannot participate in this study if you:
  • Are unable to tolerate an MRI
  • Have history of substance and alcohol abuse in the past 5 years.
  • Use birth control pills in the month prior to the start of baseline period and throughout the study.
  • Have history of regular use of other benzodiazepines, such as lorazepam or diazempam.
  • Have seizures secondary to illicit drug or alcohol use, infection, metabolic illness, cancer, multiple sclerosis, Alzheimer’s disease.
  • Have history of pseudoseizures in the last 5 years.
  • Had a suicidal attempt within the last 5 years or current significant suicidal ideation.
  • Have significantly abnormal blood work or an active medical or surgical condition.
  • Have known sensitivity or allergy to benzodiazepine compounds. 
  • Are a sexually active woman of childbearing age who is unwilling to use birth control.
  • Are a woman who is pregnant or breastfeeding. 
  • Have not been enrolled in any other drug study in past 30 days
  • Need the use of other benzodiazepines for control of seizures during the study periods.
This study includes 7 clinic visits and 17 telephone calls and takes about 19.5 hours over a period of 10 months.
Taking part in this study may or may not make your health better. If you are in the group that receives Clobazam and it proves to help your condition, you may benefit from participating in the study, but this cannot be guaranteed. It is not known why some women will respond to Clobazam and some do not. This study will help researchers learn more about ways to identify who will respond to the study drug Clobazam and how it may alleviate epilepsy. It is hoped that this information will help in predicting treatment response to Clobazam for treatment of future patients with catamenial epilepsy.
You will receive $100 at Visit 4 and $100 at Visit 7 for your participation in this study. You will not be reimbursed for any out of pocket expenses, such as parking or transportation fees.
Clobazam
Drug therapy
Shari Niswonger
949-824-3485 or 949-824-8116