Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

Danish Pain Research Center

Status and phase: Completed; Phase 4

Conditions: Pain; Injuries, Spinal Cord

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00252954

LEV-2005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 1 patient group, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Levetiracetam