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

This study has been completed.
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: October 7, 2015
Last verified: July 2015
  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:


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


Enrollment: 29
Study Start Date: June 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18 - 65 years
  • documented spinal cord injury at or below T5
  • 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 (or if the mean NRS score is >9, the mean Gracely score must be ≤19)

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
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: NCT01748695

Locations
United States, Massachusetts
Translational Pain Research, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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

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: October 7, 2015
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:
Wounds and Injuries
Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 09, 2016