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

Phase 2

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Placebo followed by V158866	Placebo	Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
V158866 followed by Placebo	Placebo	V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks
Placebo followed by V158866	V158866	Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
V158866 followed by Placebo	V158866	V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures