Pharmacogenetics of GABAergic mechanisms of benefit and harm in epilepsy: : A prospective cohort study to determine the enviromental and genetic factors associated with response to clobazam. - Pharmacogenetics:clobazam
- Conditions
- Epilepsy
- Registration Number
- EUCTR2004-003945-41-GB
- Lead Sponsor
- liverpool university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
1. Continued seizures despite current treatment with between 1 and 3 conventional antiepileptic drugs (carbamazepine, valproate, lamotrigine, phenytoin, topiramate, levetiracetam, gabapentin). Patients who may have been treated previously with AEDs not in this list will also be included.
2. Patients have been on their existing combination of AEDs for at least 3 months.
3. Addition of clobazam to existing AED regime or switch of one of current AEDs for clobazam is clinically indicated.
4. Any epilepsy syndrome (generalized, localization-related, unclassified).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Significant learning disability
2. Patient and/or relatives unable to maintain a seizure diary.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The principle research objective is to define the genetic and enviromental factors that can predict response to clobazam.;Secondary Objective: ;<br> Primary end point(s): 1. Time to withdrawal of clobazam.<br> a. For any reason<br> b. Due to side effects<br> c. Due to inadequate seizure control<br> d. Combination of b and c<br> 2. Seizure control.<br> a. Seizure frequency per month at 3, 6, 9, and 12 months.<br> b. Number of seizure free days per month at 3, 6, 9 and 12 months.<br> 3. Adverse effects<br>
- Secondary Outcome Measures
Name Time Method