Efficacy and tolerability of levetiracetam in central post-stroke pain - a randomised, double blind, placebo controlled, cross-over study
| ISRCTN | ISRCTN38932730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38932730 |
| Protocol serial number | N/A |
| Sponsor | Individual Sponsor (Germany) |
| Funders | Charité - University Medicine Berlin (Charité - Univeritätsmedizin Berlin) (Germany), Berlin Neuroimaging Centre (Germany), UCB Pharma Belgium (Belgium), UCB GmbH Kerpen (Germany) |
- Submission date
- 11/05/2005
- Registration date
- 07/06/2005
- Last edited
- 23/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Klinik für Neurologie
Charité Campus Mitte
Schumannstr. 20/21
Berlin
10117
Germany
| Phone | +49 30 450 560 145 |
|---|---|
| jan.junge-huelsing@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Efficacy and tolerability of levetiracetam in central post-stroke pain - a randomised, double blind, placebo controlled, cross-over study |
| Study acronym | LESS |
| Study objectives | Levetiracetam has a positive pain relief effect in patients with central post stroke pain and is well tolerated. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Central poststroke pain (CPSP) |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levetiracetam |
| 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. |
| Key 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). |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 49 |
| Total final enrolment | 42 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
10117
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/02/2013 | 23/02/2023 | Yes | No |
Editorial Notes
23/02/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
