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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Vernalis (R&D) Ltd

Criteria

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