Focal epilepsy, anxiety disorder
Conditions
Interventions
Trade Name: Lyrica 75 mg
Product Name: Pregabalin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin. CHMP/0845/04
CAS Number: 148553-50-8
Concentration unit: mg milligram(s)
Concentra
Sponsors
Gesellschaft für Epilepsieforschung e.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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% • Reduction of anxiety scores • Number of seizure free days, seizure intensity, seizure freedom • Retention rate of pregabalin • Adverse events and tolerability | — |
Countries
Germany
Outcome results
None listed