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

Completed · Phase 2 · Has a placebo group

Conditions studied: Neuropathic Pain Due to Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT01748695

Run by

Brigham and Women's Hospital

People needed

25

Starts

2013-06-01

Expected to finish

2015-07-01

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Translational Pain Research, Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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