|
Welcome
|
|
21 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Efficacy and Tolerability of Levetiracetam in central poststroke pain - a randomised, double blind, placebo controlled, cross-over study |
| ISRCTN | ISRCTN38932730 |
| ClinicalTrials.gov identifier | |
| Public title | Efficacy and Tolerability of Levetiracetam in central poststroke pain - a randomised, double blind, placebo controlled, cross-over study |
| Scientific title | |
| Acronym | LESS |
| Serial number at source | N/A |
| Study hypothesis | Levetiracetam has a positive pain relief effect in patients with central post stroke pain and is well tolerated. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Central poststroke pain (CPSP) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2004 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 49 |
| 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 phase starting with 1000 mg/day (14 days) to 2000 mg/day (14 days) and followed by 4 weeks of a constant dose of 3000 mg/day.
Pain diary based on NRS, lab test, cerebral magnetic resonance imaging (MRI), neurological examination including extended sensibility and sensory testing, questionnaires, drug administration. |
| Primary outcome measure(s) | 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 outcome measure(s) | 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). |
| Sources of funding |
1. Charité - University Medicine Berlin (Charité - Univeritätsmedizin Berlin) (Germany)
2. Berlin Neuroimaging Centre (Germany) 3. UCB Pharma Belgium (Belgium) 4. UCB GmbH Kerpen (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Gerhard Jan Jungehülsing |
| Address |
Klinik für Neurologie
Charité Campus Mitte Schumannstr. 20/21 |
| City/town | Berlin |
| Zip/Postcode | 10117 |
| Country | Germany |
| Tel | +49 30 450 560 145 |
| Fax | +49 30 450 560 952 |
| jan.junge-huelsing@charite.de | |
| Sponsor | Individual Sponsor (Germany) |
| Address |
Dr Gerhard Jan Jungehülsing
Klinik für Neurologie Charité Campus Mitte Schumannstr. 20/21 |
| City/town | Berlin |
| Zip/Postcode | 10117 |
| Country | Germany |
| Tel | +49 30 450 560 145 |
| Fax | +49 30 450 560 952 |
| jan.junge-huelsing@charite.de | |
| Date applied | 11/05/2005 |
| Last edited | 14/09/2009 |
| Date ISRCTN assigned | 07/06/2005 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|