Central poststroke pain (CPSP) Circulatory System Stroke
Conditions
Interventions
The study is based on a cross over design. Each randomised patient will receive 8 weeks of Levetiracetam and 8 weeks of placebo in blinded order. The medication periods consist of a 4 week titration p
Sponsors
Individual Sponsor (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Central Post Stroke Pain >3 months 3. Previous ischaemic or haemorrhagic stroke >3 months 4. Pain intensity >4 on numeric rating scale (NRS) 5. Rankin Score <2
Exclusion criteria
Exclusion criteria: 1. Dementia or other severe cognitive impairment 2. Diabetic neuropathy 3. Epilepsy 4. Severe pain other than central poststroke pain 5. Malignant disease 6. Recent myocardial infarction 7. Severe heart insufficiency 8. Severe liver or renal failiure 9. Severe hematological disease 10. Prior treatment with or known allergy to levetiracetam 11. Positive history for alcohol or for drug abuse 12. Pregnancy or lactation 13. Participation in a clinical study within two months of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is a reduction of two points in the median pain intensity on a scale 0 (no pain) to ten (maximum pain) assessed by the patient during the last week of treatment with 3000 mg levetiracetam or placebo compared to the median pain intensity assessed in the second pre-treatment baseline week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the median pain scale during the last week of treatment with 1000 mg and 2000 mg levetiracetam or placebo. Further secondary endpoints are the results of the clinical sensory and pain assessment and the results of the NRS (Numeric Rating Scale), Beck Depression Inventary, the SF36 (Short Form-36 Health Survey (Quality of Life) as well as the PSQI (Pittsburgh Sleep Quality Index). | — |
Countries
Germany
Outcome results
None listed