Levetiracetam for Painful Polyneuropathy

This study has been completed.

Sponsor:

Information provided by:

Odense University Hospital

ClinicalTrials.gov Identifier:

NCT00286260

First received: February 1, 2006

Last updated: December 17, 2009

Last verified: January 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2006

Last Updated Date

December 17, 2009

Start Date ^ICMJE

January 2006

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period) [ Time Frame: Daily ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00286260 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain rated on 0 to 10 point numeric rating scales [ Time Frame: Daily ] [ Designated as safety issue: No ]
Pain subtypes rated on 0 to 10 point numeric rating scales [ Time Frame: Daily ] [ Designated as safety issue: No ]
Bruch-evoked pain [ Time Frame: Baseline and end of each treament period ] [ Designated as safety issue: No ]
Pin-prick evoked pain [ Time Frame: Baseline and end of each treatment period ] [ Designated as safety issue: No ]
Cold evoked pain [ Time Frame: Baseline and end of each treatment period ] [ Designated as safety issue: No ]
Health related quality of life(SF-36) [ Time Frame: Baseline and end of each treatment period ] [ Designated as safety issue: No ]
Pain related sleep disturbance [ Time Frame: Daily ] [ Designated as safety issue: No ]
Use of escape medication [ Time Frame: Daily ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Levetiracetam for Painful Polyneuropathy

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Painful Polyneuropathy

Intervention ^ICMJE

Drug: levetiracetam

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00286260

Other Study ID Numbers ^ICMJE

keppra2

Has Data Monitoring Committee

Not Provided

Responsible Party

Professor Søren H. Sindrup, Odense University Hospital

Study Sponsor ^ICMJE

Odense University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Søren H Sindrup, Professor

Department of Neurology, Odense Unviersity Hospital

Information Provided By

Odense University Hospital

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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