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A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury

This study is currently recruiting participants.
Verified March 2013 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Vernalis (R&D) Ltd
Information provided by (Responsible Party):
Christine N. Sang, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01748695
First received: December 11, 2012
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to investigate whether V158866 is safe and effective for the treatment of neuropathic pain due to spinal cord injury.


Condition Intervention Phase
Neuropathic Pain Due to Spinal Cord Injury
 Drug: V158866
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study Evaluating the Safety, Tolerability and Efficacy of V158866 in Central Neuropathic Pain Following Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change from baseline in mean pain intensity scores on the NRS. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the comparison of the overall pain intensity on the NRS for the last 7 days of each treatment period. (V158866 compared to placebo)

  • Safety and tolerability of V158866 compared to placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    Safety and tolerability measured by:

    Adverse events, Columbia Suicide Severity Rating Scale change from baseline, Vital signs change from baseline, 12-lead ECG change from baseline, Beck Depression Inventory change from baseline, Laboratory safety tests changes from baseline, ARC Inventory - marijuana change from baseline, RBANS change from baseline



Secondary Outcome Measures:
  • Gracely pain scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Gracely pain scores will be compared between V158866 and placebo treatment.

  • Sleep interference [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Sleep interference scores will be compared between treatment with V158866 and placebo.

  • Quantitative Sensory Testing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Quantitative Sensory Testing parameters will be compared between treatment with V158866 and placebo


Estimated Enrollment: 36
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo followed by V158866
Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
 Drug: V158866 Drug: Placebo
Experimental: V158866 followed by Placebo
V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks
 Drug: V158866 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18 - 65 years
  • documented spinal cord injury at or below T7
  • moderate pain at or below the level of the spinal cord injury for at least 3 months
  • compliant with daily diary
  • stable pain scores on the NRS
  • mean pain intensity of at least 4 and not more than 9 on the NRS

Exclusion Criteria:

  • women of child-bearing potential
  • men who intend to father a child
  • a history of multiple drug allergies, hypersensitivity to any cannabinoid
  • an increased risk of seizure
  • evidence of depression and/or a score of >19 on the BDI-II
  • suicidal ideation or suicidal behavior in the past 10 years
  • a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
  • a positive urine test for cannabis at screening
  • taking excluded medications that cannot be stopped
  • a positive pregnancy test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748695

Contacts
Contact: Christine N Sang, MD, MPH csang@partners.org
Contact: Kierin O'Donnell kodonnell8@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Christine N Sang, MD, MPH            
Sponsors and Collaborators
Brigham and Women's Hospital
Vernalis (R&D) Ltd
Investigators
Principal Investigator: Christine N Sang, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Christine N. Sang, MD, MPH, Dr Christine Sang, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01748695     History of Changes
Other Study ID Numbers: V158866-2Pa-01
Study First Received: December 11, 2012
Last Updated: March 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Neuropathic pain
Spinal cord injury

Additional relevant MeSH terms:
Neuralgia
Spinal Cord Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013