Neuropathic Pain Due to Spinal Cord Injury Clinical Trial
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
| Verified date | April 2017 |
| Source | Brigham and Women's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Translational Pain Research, Brigham and Women's Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Brigham and Women's Hospital | Vernalis (R&D) Ltd |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | 4 Weeks | |
| Primary | 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. | 4 weeks |