Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury
This study has been completed.
Sponsor:
Danish Pain Research Center
Collaborator:
UCB NORDIC A/S
Information provided by:
Danish Pain Research Center
ClinicalTrials.gov Identifier:
NCT00252954
First received: November 14, 2005
Last updated: August 19, 2009
Last verified: August 2009
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 |
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 |
|---|---|
| Placebo Comparator: 1 |
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 | |
| 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
Investigators
| Principal Investigator: | Nanna B Finnerup, MD | Aarhus University Hospital |
More Information
Additional Information:
No publications provided by Danish Pain Research Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nanna Brix Finnerup, Danish Pain Research Center |
| ClinicalTrials.gov Identifier: | NCT00252954 History of Changes |
| Other Study ID Numbers: | LEV-2005 |
| Study First Received: | November 14, 2005 |
| Last Updated: | August 19, 2009 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Danish Pain Research Center:
|
Spinal cord injury Neuropathic pain Spasms |
Additional relevant MeSH terms:
|
Neuralgia Spinal Cord Injuries Spinal Injuries Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System |
Wounds and Injuries Back Injuries Etiracetam Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013