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

Klinik für Neurologie
Charité Campus Mitte
Schumannstr. 20/21
Berlin
10117
Germany

Phone +49 30 450 560 145
Email jan.junge-huelsing@charite.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEfficacy and tolerability of levetiracetam in central post-stroke pain - a randomised, double blind, placebo controlled, cross-over study
Study acronymLESS
Study objectivesLevetiracetam 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) studiedCentral poststroke pain (CPSP)
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Levetiracetam
Primary outcome measurePrimary 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 measuresSecondary 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 date01/10/2004
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants49
Total final enrolment42
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2004
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Klinik für Neurologie
Berlin
10117
Germany

Sponsor information

Individual Sponsor (Germany)
University/education

Dr Gerhard Jan Jungehülsing
Klinik für Neurologie
Charité Campus Mitte
Schumannstr. 20/21
Berlin
10117
Germany

Phone +49 30 450 560 145
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.