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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Neuropathic Pain Due to Spinal Cord Injury

Treatments: Drug: Placebo; Drug: V158866

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01748695

V158866-2Pa-01

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Placebo followed by V158866

Experimental group

Description:

Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks

Treatment:

Drug: V158866

Drug: Placebo

V158866 followed by Placebo

Experimental group

Description:

V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks

Treatment:

Drug: V158866

Drug: Placebo