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 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gerhard Jan Jungehülsing
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levetiracetam |
| Primary outcome measure | 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 measures | 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). |
| Overall study start date | 01/10/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Klinik für Neurologie
Berlin
10117
Germany
10117
Germany
Sponsor information
Individual Sponsor (Germany)
University/education
University/education
Dr Gerhard Jan Jungehülsing
Klinik für Neurologie
Charité Campus Mitte
Schumannstr. 20/21
Berlin
10117
Germany
| Phone | +49 30 450 560 145 |
|---|---|
| jan.junge-huelsing@charite.de |
Funders
Funder type
Industry
Charité - University Medicine Berlin (Charité - Univeritätsmedizin Berlin) (Germany)
No information available
Berlin Neuroimaging Centre (Germany)
No information available
UCB Pharma Belgium (Belgium)
No information available
UCB GmbH Kerpen (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
