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

Primary Purpose

Spinal Cord Trauma, Pain

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Lyrica

matching placebo

About this trial

This is an interventional prevention trial for Spinal Cord Trauma focused on measuring The outcome is to prevent Central Neuropathic Pain, participants will have suffered spinal cord trauma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study.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

Sites / Locations

N.S Rehabilitation Center ,Capital Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

Pregabalin, (other name) Lyrica

pregabalin, drug

Arm Description

Study subjects wil be randomized to either the Pregabalin or Placebo group. There is a 5o ,50 chance of being in either group.

study subjects that are randomized to the placebo group will receive matching placebo

Outcomes

Primary Outcome Measures

The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .

Secondary Outcome Measures

Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.

Full Information

NCT ID

NCT00879021

First Posted

April 8, 2009

Last Updated

July 29, 2013

Sponsor

Nova Scotia Health Authority

1. Study Identification

Unique Protocol Identification Number

NCT00879021

Brief Title

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

Official Title

Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Terminated

Why Stopped

lack of funding and patients

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Trauma, Pain

Keywords

The outcome is to prevent Central Neuropathic Pain, participants will have suffered spinal cord trauma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin, (other name) Lyrica

Arm Type

Placebo Comparator

Arm Description

Study subjects wil be randomized to either the Pregabalin or Placebo group. There is a 5o ,50 chance of being in either group.

Arm Title

pregabalin, drug

Arm Type

Placebo Comparator

Arm Description

study subjects that are randomized to the placebo group will receive matching placebo

Intervention Type

Drug

Intervention Name(s)

Lyrica

Other Intervention Name(s)

Pregablin , also known as Lyrica, an approved drug.

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

matching placebo

Intervention Description

150 mg by mouth ,twice a day for 49 weeks

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.

Time Frame

trail is 74 weeks in length

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine A. Short, Md FRCPC

Organizational Affiliation

Capital Health DHA Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

N.S Rehabilitation Center ,Capital Health

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3h 4K4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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