Contact information
Type
Scientific
Primary contact
Dr Gerhard Jan Jungehülsing
ORCID ID
Contact details
Klinik für Neurologie
Charité Campus Mitte
Schumannstr. 20/21
Berlin
10117
Germany
+49 30 450 560 145
jan.junge-huelsing@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LESS
Study hypothesis
Levetiracetam has a positive pain relief effect in patients with central post stroke pain and is well tolerated.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Levetiracetam
Primary outcome measures
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 trial start date
01/10/2004
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
49
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik für Neurologie
Berlin
10117
Germany
Sponsor information
Organisation
Individual Sponsor (Germany)
Sponsor details
Dr Gerhard Jan Jungehülsing
Klinik für Neurologie
Charité Campus Mitte
Schumannstr. 20/21
Berlin
10117
Germany
+49 30 450 560 145
jan.junge-huelsing@charite.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Charité - University Medicine Berlin (Charité - Univeritätsmedizin Berlin) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Berlin Neuroimaging Centre (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
UCB Pharma Belgium (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
UCB GmbH Kerpen (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary