Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury - Full Text View

Sponsor:	Danish Pain Research Center
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Levetiracetam

U.S. FDA Resources

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 ]

Enrollment:	36
Study Start Date:	November 2005
Study Completion Date:	December 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

Additional Information:

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

No publications provided

Responsible Party:	Danish Pain Research Center ( Nanna Brix Finnerup )
Study ID Numbers:	LEV-2005
Study First Received:	November 14, 2005
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00252954 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Danish Pain Research Center:

Spinal cord injury
Neuropathic pain
Spasms

Additional relevant MeSH terms:

Nootropic Agents
Spinal Cord Diseases
Physiological Effects of Drugs
Nervous System Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Protective Agents
Neuroprotective Agents

Pharmacologic Actions
Spinal Cord Injuries
Spinal Injuries
Therapeutic Uses
Back Injuries
Piracetam
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 25, 2009