Levetiracetam for Painful Polyneuropathy

Phase 4

Completed

• Conditions: Painful Polyneuropathy

• Registration Number: NCT00286260
• Lead Sponsor: Odense University Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-01
• Study Start: 2006-01
• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-03
• Primary Completion: 2008-08
• Study Completion: 2008-10
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period)	Daily

Secondary Outcome Measures

Name	Time	Method
Pain rated on 0 to 10 point numeric rating scales	Daily
Cold evoked pain	Baseline and end of each treatment period
Health related quality of life(SF-36)	Baseline and end of each treatment period
Pain subtypes rated on 0 to 10 point numeric rating scales	Daily
Pin-prick evoked pain	Baseline and end of each treatment period
Bruch-evoked pain	Baseline and end of each treament period
Pain related sleep disturbance	Daily
Use of escape medication	Daily

Trial Locations

Locations (1)

Department of Neurology, Odense University Hospital; 🇩🇰 Odense C, Denmark