Phase 2
N=25
A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
Neuropathic Pain Due to Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01748695 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Mean Pain Intensity (NRS) — 5.93; 5.89 units on a scale — p=0.834
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- V158866 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Intensity (NRS) |
5.93; 5.89 | 0.834 |
| PRIMARY Safety and Tolerability of V158866 Compared to Placebo |
7; 12 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01748695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.