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

NCT00879021 | Terminated Phase 3

• 1 other identifier: Pregabalin and SCI-Short
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Trauma; Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  the trial is 74 weeks in length

Secondary Outcomes (1)

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

  trail is 74 weeks in length

Study Arms (2)

Pregabalin, (other name) Lyrica

PLACEBO COMPARATOR

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

pregabalin, drug

PLACEBO COMPARATOR

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

Drug: matching placebo

Interventions

Lyrica DRUG

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.

Also known as: Pregablin , also known as Lyrica, an approved drug.

Pregabalin, (other name) Lyrica

matching placebo DRUG

150 mg by mouth ,twice a day for 49 weeks

pregabalin, drug

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

N.S Rehabilitation Center ,Capital Health

Halifax, Nova Scotia, B3h 4K4, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pain

Interventions

Pregabalin

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Christine A. Short, Md FRCPC

  Capital Health DHA Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, FACP

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

CA (1)