Back to resultsA Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
Primary Purpose
Neuropathic Pain Due to Spinal Cord Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
V158866
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain Due to Spinal Cord Injury focused on measuring Neuropathic pain, Spinal cord injury
Eligibility 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
Sites / Locations
- Translational Pain Research, Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo followed by V158866
V158866 followed by Placebo
Arm Description
Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks
Outcomes
Primary Outcome Measures
Mean Pain Intensity (NRS)
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).
Safety and Tolerability of V158866 Compared to Placebo
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01748695
First Posted
December 11, 2012
Last Updated
April 10, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
Vernalis (R&D) Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01748695
Brief Title
A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Vernalis (R&D) Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain Due to Spinal Cord Injury
Keywords
Neuropathic pain, Spinal cord injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo followed by V158866
Arm Type
Experimental
Arm Description
Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
Arm Title
V158866 followed by Placebo
Arm Type
Experimental
Arm Description
V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks
Intervention Type
Drug
Intervention Name(s)
V158866
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean Pain Intensity (NRS)
Description
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).
Time Frame
4 Weeks
Title
Safety and Tolerability of V158866 Compared to Placebo
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine N Sang, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Translational Pain Research, Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
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