Effectiveness and safety of pregabalin in patients with epilepsy and anxiety disorder. - N/A
- Conditions
- Focal epilepsy, anxiety disorder
- Registration Number
- EUCTR2005-004074-24-DE
- Lead Sponsor
- Gesellschaft für Epilepsieforschung e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Refractory focal epilepsy
•Anxiety disorder (control group without anxiety disorder)
•Adults (=18 years)
•Antiepileptic comedication, = 2 drugs (active VNS will not be considered an AED)
•Exclusion of pregnancy, sexual abstinence or reliable method of contraception (in women of childbearing age)
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
•Pregnancy or lactation period
•Known intolerability of pregabalin
•Alcohol dependency or dependency of illicit drugs within the last 2 years
•Severe disorder of metabolism, progressive disease, severe renal impairment
•Abnormality of laboratory results of clinical significance or with clinical symptoms
•Status epilepticus within the last 6 months
•Participation in other clinical trials/ drug trials within the last 3 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy and safety of pregabalin in refractory focal epilepsy.;Secondary Objective: Efficacy of pregabalin in anxiety disorder; changes in amygdala activation (fMRI) under therapy with pregabalin (subgroup);Primary end point(s): •Seizure reduction of =50%<br>•Reduction of anxiety scores<br>•Number of seizure free days, seizure intensity, seizure freedom<br>•Retention rate of pregabalin<br>•Adverse events and tolerability<br>
- Secondary Outcome Measures
Name Time Method