Condition category
Circulatory System
Date applied
11/05/2005
Date assigned
07/06/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes