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Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury

This study has been terminated.
(lack of funding and patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879021
First Posted: April 9, 2009
Last Update Posted: July 30, 2013
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.
Information provided by (Responsible Party):
Christine Short, Capital District Health Authority, Canada
  Purpose
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 Intervention Phase
Spinal Cord Trauma Pain Drug: Lyrica Drug: matching placebo Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Christine Short, Capital District Health Authority, Canada:

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

Enrollment: 5
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00879021


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

Responsible Party: Christine Short, MD, FRCPC, FACP, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00879021     History of Changes
Other Study ID Numbers: Pregabalin and SCI-Short
First Submitted: April 8, 2009
First Posted: April 9, 2009
Last Update Posted: July 30, 2013
Last Verified: July 2013

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

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