Levetiracetam for Painful Polyneuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-10-31

Brief Summary

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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

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Conditions

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Painful Polyneuropathy

Keywords

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polyneuropathy neuropathic pain levetiracetam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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levetiracetam

Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Odense University Hospital

Principal Investigators

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Søren H Sindrup, Professor

Role: STUDY_CHAIR

Department of Neurology, Odense Unviersity Hospital

Locations

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Department of Neurology, Odense University Hospital

Odense C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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keppra2

Identifier Type: -

Identifier Source: org_study_id