Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury - Tabular View

Tracking Information

First Received Date ^ICMJE

November 14, 2005

Last Updated Date

August 19, 2009

Start Date ^ICMJE

November 2005

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment. [ Time Frame: Last week of each 5-week treatment period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment.

Change History

Complete list of historical versions of study NCT00252954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Spasms and spasticity; pain relief for total, at- and below-level pain; evoked pain; escape medication; NPSI; predictive value of the presence of evoked pain; Global impression of change; sleep disturbance. [ Time Frame: Last day of each 5-week treatment period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

Official Title ^ICMJE

Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study

Brief Summary

Purpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain after spinal cord injury, and to examine its effect on spasms and evoked pain.

Detailed Description

Study design: Randomized double-blind cross-over study of levetiracetam (Keppra) against corresponding placebo with a 1 week baseline period followed by 2 x 5 weeks treatment periods separated by a 1 week wash-out period.

Methodology: Levetiracetam and corresponding placebo is gradually increased during two weeks from 500 mg x 2 daily to 1500 mg x 2 daily (1000 mg x 2 daily is allowed if 1500 mg x 2 is not tolerated), and kept on that dose for three weeks.

The study will be monitored by the GCP units of Aarhus and Copenhagen University.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Injuries, Spinal Cord
Pain

Intervention ^ICMJE

Drug: Levetiracetam

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

1. age 18 or more
2. neuropathic pain (that have lasted at least 3 month) after a spinal cord injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale

Exclusion Criteria:

1. pregnancy or lactation
2. allergy to levetiracetam
3. alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00252954

Responsible Party

Nanna Brix Finnerup, Danish Pain Research Center

Study ID Numbers ^ICMJE

LEV-2005

Study Sponsor ^ICMJE

Danish Pain Research Center

Collaborators ^ICMJE

UCB NORDIC A/S

Investigators ^ICMJE

Principal Investigator:

Nanna B Finnerup, MD

Aarhus University Hospital

Information Provided By

Danish Pain Research Center

Verification Date

August 2009

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