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:
Information provided by (Responsible Party):
Christine Short, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00879021
First received: April 8, 2009
Last updated: July 29, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879021

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

No publications provided

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
Study First Received: April 8, 2009
Last Updated: July 29, 2013
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Neuralgia
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014