Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

NCT00252954 | Completed Phase 4 DMC

• 1 other identifier: LEV-2005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Injuries, Spinal Cord; Pain

Keywords

Spinal cord injury; Neuropathic pain; Spasms

Outcome Measures

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.

  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.

  Last day of each 5-week treatment period

Study Arms (1)

1

PLACEBO COMPARATOR

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

Tablets 2000-3000 mg per day

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. age 18 or more
• \. 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

You may not qualify if:

• \. pregnancy or lactation
• \. allergy to levetiracetam
• \. alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage

Sponsors & Collaborators

• Danish Pain Research Center: lead
• UCB Nordic A/S: collaborator

Study Sites (3)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Clinic for Spinal Cord Injuries, Rigshospitalet

Hornbæk, 3100, Denmark

Location

The Spinal Cord Unit, Dept of Rheumatology

Viborg, 8800, Denmark

Location

Related Publications (1)

• Finnerup NB, Grydehoj J, Bing J, Johannesen IL, Biering-Sorensen F, Sindrup SH, Jensen TS. Levetiracetam in spinal cord injury pain: a randomized controlled trial. Spinal Cord. 2009 Dec;47(12):861-7. doi: 10.1038/sc.2009.55. Epub 2009 Jun 9.

  PMID: 19506571 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Pain; Neuralgia; Spasm

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nanna B Finnerup, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 15, 2005
• Study Start: November 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 20, 2009

Record last verified: 2009-08

Locations

DK (3)