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