Painful Polyneuropathy
Conditions
Keywords
polyneuropathy, neuropathic pain, levetiracetam
Brief summary
Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy
Interventions
DRUGlevetiracetam
Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 20 to 0 years * painful symptoms of polyneuropathy for at least 6 months * confirmed diagnosis of polyneuropathy * baseline pain score of 4 or more (0 to 10 point scale) * pain at least 4 days a week * adequate anticonceptive treatment for women with childbearing potential * informed consent
Exclusion criteria
* other cause of pain * previous allergic reactions towards levetiracetam * known adverse drug reactions on levetiracetam * pregnancy * severe disease * inability to follow study protocol * treatment with antidepressants, other anticonvulsants or opioids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period) | Daily |
Secondary
| Measure | Time frame |
|---|---|
| Pain subtypes rated on 0 to 10 point numeric rating scales | Daily |
| Bruch-evoked pain | Baseline and end of each treament period |
| Pin-prick evoked pain | Baseline and end of each treatment period |
| Pain rated on 0 to 10 point numeric rating scales | Daily |
| Health related quality of life(SF-36) | Baseline and end of each treatment period |
| Pain related sleep disturbance | Daily |
| Use of escape medication | Daily |
| Cold evoked pain | Baseline and end of each treatment period |
Countries
Denmark
Outcome results
None listed