Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy

Odense University Hospital1 site in 1 country40 target enrollmentJanuary 2006

ConditionsPainful Polyneuropathy

Drugslevetiracetam

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Painful Polyneuropathy
Sponsor: Odense University Hospital
Enrollment: 40
Locations: 1
Primary Endpoint: Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

October 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Odense University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Daily

Secondary Outcomes

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)