Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252954
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : August 20, 2009
UCB Nordic A/S
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Injuries, Spinal Cord Pain Drug: Levetiracetam Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study
Study Start Date : November 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Levetiracetam
Tablets 2000-3000 mg per day

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00252954

Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Clinic for Spinal Cord Injuries, Rigshospitalet
Hornbaek, Denmark, 3100
The Spinal Cord Unit, Dept of Rheumatology
Viborg, Denmark, 8800
Sponsors and Collaborators
Danish Pain Research Center
UCB Nordic A/S
Principal Investigator: Nanna B Finnerup, MD Aarhus University Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nanna Brix Finnerup, Danish Pain Research Center Identifier: NCT00252954     History of Changes
Other Study ID Numbers: LEV-2005
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: August 20, 2009
Last Verified: August 2009

Keywords provided by Danish Pain Research Center:
Spinal cord injury
Neuropathic pain

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Back Injuries
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs