Neuropathic Pain Due to Spinal Cord Injury
Conditions
Keywords
Neuropathic pain, Spinal cord injury
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.
Interventions
DRUGV158866
DRUGPlacebo
Sponsors
Vernalis (R&D) Ltd
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Intensity (NRS) | 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). |
| Safety and Tolerability of V158866 Compared to Placebo | 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. |
Countries
United States
Participant flow
Pre-assignment details
Included a 14-day period to exclude non-compliers, extremes of pain ratings, and those with high variability
Participants by arm
| Arm | Count |
|---|---|
| V158866 and Placebo Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | V158866 and Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 25 | 12 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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).
Time frame: 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Intensity (NRS) | 5.93 units on a scale | Standard Error 0.148 |
| V158866 | Mean Pain Intensity (NRS) | 5.89 units on a scale | Standard Error 0.148 |
p-value: 0.834Regression, Linear
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.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Safety and Tolerability of V158866 Compared to Placebo | 7 Participants |
| V158866 | Safety and Tolerability of V158866 Compared to Placebo | 12 Participants |