DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Levetiracetam for Painful Polyneuropathy

Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Painful Polyneuropathy

Intervention: levetiracetam (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Odense University Hospital

Official(s) and/or principal investigator(s):
Søren H Sindrup, Professor, Study Chair, Affiliation: Department of Neurology, Odense Unviersity Hospital

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

Pain rated on 0 to 10 point numeric rating scales

Pain subtypes rated on 0 to 10 point numeric rating scales

Bruch-evoked pain

Pin-prick evoked pain

Cold evoked pain

Health related quality of life(SF-36)

Pain related sleep disturbance

Use of escape medication

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Department of Neurology, Odense University Hospital, Odense C DK-5000, Denmark
Additional Information

Starting date: January 2006
Last updated: December 17, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017