Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

Phase 4

Completed

• Conditions: Injuries, Spinal Cord; Pain
• Interventions: Drug: Levetiracetam

• Registration Number: NCT00252954
• Lead Sponsor: Danish Pain Research Center

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Primary Completion: 2008-03
• Study Completion: 2008-12
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-19
• Last Update Posted: 2009-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Levetiracetam	-

Primary Outcome Measures

Name	Time	Method
Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment.	Last week of each 5-week treatment period

Secondary Outcome Measures

Name	Time	Method
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.	Last day of each 5-week treatment period

Trial Locations

Locations (3)

Danish Pain Research Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Clinic for Spinal Cord Injuries, Rigshospitalet; 🇩🇰 Hornbaek, Denmark

The Spinal Cord Unit, Dept of Rheumatology; 🇩🇰 Viborg, Denmark