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Completed

NCT Number: NCT00252954

Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

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.

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Key information

Conditions

Injuries, Spinal Cord Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spasm Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Danish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Tablets 2000-3000 mg per day

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • UCB Nordic A/S

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 15, 2005
Registry last updated
Aug 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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