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Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Danish Pain Research Center
UCB NORDIC A/S
Information provided by: Danish Pain Research Center
ClinicalTrials.gov Identifier: NCT00252954
  Purpose

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 Intervention Phase
Injuries, Spinal Cord
Pain
Drug: Levetiracetam
Phase IV

MedlinePlus related topics:   Spinal Cord Injuries   

ChemIDplus related topics:   Levetiracetam   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study

Further study details as provided by Danish Pain Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:   30
Study Start Date:   November 2005
Estimated Study Completion Date:   June 2008
Primary Completion Date:   March 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Placebo Comparator Drug: Levetiracetam
Tablets 2000-3000 mg per day

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252954

Locations
Denmark
Danish Pain Research Center, Aarhus University Hospital    
      Aarhus, Denmark, 8000
The Spinal Cord Unit, Dept of Rheumatology    
      Viborg, Denmark, 8800
Clinic for Spinal Cord Injuries, Rigshospitalet    
      Hornbaek, Denmark, 3100

Sponsors and Collaborators
Danish Pain Research Center
UCB NORDIC A/S

Investigators
Principal Investigator:     Nanna B Finnerup, MD     Aarhus University Hospital    
  More Information

Danish Pain Research Center  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Danish Pain Research Center ( Nanna Brix Finnerup )
Study ID Numbers:   LEV-2005
First Received:   November 14, 2005
Last Updated:   May 20, 2008
ClinicalTrials.gov Identifier:   NCT00252954
Health Authority:   Denmark: Danish Medicines Agency

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

Study placed in the following topic categories:
Spasm
Spinal Cord Injuries
Spinal Cord Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Etiracetam
Pain
Trauma, Nervous System

Additional relevant MeSH terms:
Nootropic Agents
Therapeutic Uses
Nervous System Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on September 04, 2008




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