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 scalesPain 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
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