Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute 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: NCT00879021
Recruitment Status : Terminated (lack of funding and patients)
First Posted : April 9, 2009
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
Christine Short, Nova Scotia Health Authority

Brief Summary:
This research study will test to see if people who receive pregabalin after their spinal cord injury will develop less nerve damage pain than people who do not receive it.

Condition or disease Intervention/treatment Phase
Spinal Cord Trauma Pain Drug: Lyrica Drug: matching placebo Phase 3

Detailed Description:

Pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of central NeP in SCI. Research is now proving that it is possible to prevent the development of pain in certain conditions. Pregabalin has been proven effective in this area with post surgical pain. Therefore, after traumatic SCI there may be a small window of time where we could prevent the development of NeP by administering an agent like Pregabalin.

Objective: To test the hypothesis that pregabalin is an effective treatment in preventing post-spinal cord injury neuropathic pain.

Design: double-blind, placebo controlled, randomized, trial Setting: Spinal cord injury program, neurosurgery and tertiary care rehabilitation center Subjects: 30 patients with acute traumatic spinal cord injury Method: Pregabalin will be offered to patients with acute traumatic spinal cord injury pain in a double blind crossover, placebo control design.

Main Outcome Measures: The primary outcome measures will be the development of Neuropathic Pain and intensity of pain Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.

Results: To be determined. Conclusion: To be determined.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial.
Study Start Date : September 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Placebo Comparator: Pregabalin, (other name) Lyrica
Study subjects wil be randomized to either the Pregabalin or Placebo group. There is a 5o ,50 chance of being in either group.
Drug: Lyrica
study participants will start will be on 150mg of Pregabalin or placebo capsules by mouth , twice a day.They will be on drug approx. 49 weeks and followed for another 49 weeks after stopping the medication.
Other Name: Pregablin , also known as Lyrica, an approved drug.

Placebo Comparator: pregabalin, drug
study subjects that are randomized to the placebo group will receive matching placebo
Drug: matching placebo
150 mg by mouth ,twice a day for 49 weeks

Primary Outcome Measures :
  1. The primary outcome measures will be the development of Neuropathic Pain and intensity of pain . [ Time Frame: the trial is 74 weeks in length ]

Secondary Outcome Measures :
  1. Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores. [ Time Frame: trail is 74 weeks in length ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eligible participants will be 18 years of age or older
  • Have suffered a traumatic spinal cord injury (complete or incomplete)
  • Be free of Neuropathic pain
  • Be in stable medical condition

Exclusion Criteria:

  • Pregnant or lactating women: Because we do not know the risks of pregabalin in pregnancy, females of child bearing years must have a negative pregnancy test (performed on screening and subsequent follow up visits) and be using a reliable method of birth control including oral or injectible birth control hormones, barriers, intrauterine devices or tubal ligation, or abstinence throughout the duration of the study.
  • Should a female become pregnant while participating in the study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study. Appropriate follow-up for any pregnancy complications will be conducted.
  • Persons with known hypersensitivity to pregabalin or its constituents
  • Persons with Neuropathic pain at the time of enrollment
  • Persons with a chronic pain diagnoses that may interfere with the evaluation of the presence of Neuropathic pain

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): NCT00879021

Canada, Nova Scotia
N.S Rehabilitation Center ,Capital Health
Halifax, Nova Scotia, Canada, B3h 4K4
Sponsors and Collaborators
Nova Scotia Health Authority
Principal Investigator: Christine A. Short, Md FRCPC Capital Health DHA Canada

Responsible Party: Christine Short, MD, FRCPC, FACP, Nova Scotia Health Authority Identifier: NCT00879021     History of Changes
Other Study ID Numbers: Pregabalin and SCI-Short
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by Christine Short, Nova Scotia Health Authority:
The outcome is to prevent Central Neuropathic Pain
participants will have suffered spinal cord trauma

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs