Painful Polyneuropathy Clinical Trial
Official title:
Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy
| Verified date | January 2006 |
| Source | Odense University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | October 2008 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Neurology, Odense University Hospital | Odense C |
| Lead Sponsor | Collaborator |
|---|---|
| Odense University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period) | Daily | No | |
| Secondary | Pain rated on 0 to 10 point numeric rating scales | Daily | No | |
| Secondary | Pain subtypes rated on 0 to 10 point numeric rating scales | Daily | No | |
| Secondary | Bruch-evoked pain | Baseline and end of each treament period | No | |
| Secondary | Pin-prick evoked pain | Baseline and end of each treatment period | No | |
| Secondary | Cold evoked pain | Baseline and end of each treatment period | No | |
| Secondary | Health related quality of life(SF-36) | Baseline and end of each treatment period | No | |
| Secondary | Pain related sleep disturbance | Daily | No | |
| Secondary | Use of escape medication | Daily | No |