Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252954
• Other study ID #: LEV-2005
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2005
• Last updated: August 19, 2009
• Start date: November 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Injuries, Spinal Cord
• Neuralgia
• Pain
• Spinal Cord Injuries
• Spinal Injuries

Intervention

Drug:
• Levetiracetam
Tablets 2000-3000 mg per day

Locations

Country	Name	City	State
Denmark	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

Sponsors (2)

Lead Sponsor	Collaborator
Danish Pain Research Center	UCB Nordic A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Danish Pain Research Center