Double-blind, randomised, placebo-controlled trial of levetiracetam for central neuropathic pain in patients with multiple sclerosis - levetiracetam for central neuropathic pain in patients with multiple sclerosis
- Registration Number
- EUCTR2006-000397-71-DK
- Lead Sponsor
- Søren H. Sindrup, Department of Neurology, Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1.The diagnoses multiple sclerosis verified by neurologist
2.age over 18 years
3.neuropathic pain which for at least 3 months and had its onset at least 6 months after the diagnoses multiple sclerosis had been verified
4.average baseline pain score of at least 4 on a 0 to 10 numeric rating scale
5.informed consent
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.additional cause of pain
2.allergic reactions towards levettiracetam
3.pregnancy or beast feeding period
4.severe illness
5.lack of ability to follow study protocol
6.treatment with antidepressants, anticonvulsants or opioids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if levetiracetam will relieve central neuropathic pain in multiple sclerosis<br><br><br>;Secondary Objective: In patients with central neuropathic pain in multiple sclerosis to determine the effect of levetiracetam <br>1- specific pain symptoms<br>2-on quality of life<br>3-pain related sleep disturbance<br>4-on spasticity<br><br><br><br> ;Primary end point(s): Patients verbal score of pain relief (complete, good, moderate, slight, no, worse) at the end of each treatment period
- Secondary Outcome Measures
Name Time Method