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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01748695
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Vernalis (R&D) Ltd
Information provided by (Responsible Party):
Christine N. Sang, MD, MPH, Brigham and Women's Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Neuropathic Pain Due to Spinal Cord Injury Drug: V158866 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : June 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Pain Intensity (NRS) [ Time Frame: 4 Weeks ]
    Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo).

  2. Safety and Tolerability of V158866 Compared to Placebo [ Time Frame: 4 weeks ]
    Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748695


Locations
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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
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Principal Investigator: Christine N Sang, MD, MPH Brigham and Women's Hospital
More Information
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Responsible Party: Christine N. Sang, MD, MPH, Dr Christine Sang, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01748695    
Other Study ID Numbers: V158866-2Pa-01
First Posted: December 12, 2012    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: April 2017
Keywords provided by Christine N. Sang, MD, MPH, Brigham and Women's Hospital:
Neuropathic pain
Spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations