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

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

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.

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