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Levetiracetam for Painful Polyneuropathy

Primary Purpose

Painful Polyneuropathy

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

levetiracetam

About this trial

This is an interventional treatment trial for Painful Polyneuropathy focused on measuring polyneuropathy, neuropathic pain, levetiracetam

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Neurology, Odense University Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00286260

First Posted

February 1, 2006

Last Updated

December 17, 2009

Sponsor

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00286260

Brief Title

Levetiracetam for Painful Polyneuropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Odense University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Polyneuropathy

Keywords

polyneuropathy, neuropathic pain, levetiracetam

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

levetiracetam

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Pain rated on 0 to 10 point numeric rating scales

Time Frame

Daily

Title

Pain subtypes rated on 0 to 10 point numeric rating scales

Time Frame

Daily

Title

Bruch-evoked pain

Time Frame

Baseline and end of each treament period

Title

Pin-prick evoked pain

Time Frame

Baseline and end of each treatment period

Title

Cold evoked pain

Time Frame

Baseline and end of each treatment period

Title

Health related quality of life(SF-36)

Time Frame

Baseline and end of each treatment period

Title

Pain related sleep disturbance

Time Frame

Daily

Title

Use of escape medication

Time Frame

Daily

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Søren H Sindrup, Professor

Organizational Affiliation

Department of Neurology, Odense Unviersity Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Neurology, Odense University Hospital

City

Odense C

ZIP/Postal Code

DK-5000

Country

Denmark

12. IPD Sharing Statement

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Levetiracetam for Painful Polyneuropathy

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