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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neuropathic Pain Due to Spinal Cord Injury

Intervention / Treatment
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* Drug: V158866
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo followed by V158866<br>Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks | Drug: V158866<br> <br> Drug: Placebo<br> <br> |
| Experimental: V158866 followed by Placebo<br>V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks | Drug: V158866<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pain Intensity (NRS) | Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo). | 4 Weeks | 
| Safety and Tolerability of V158866 Compared to Placebo | Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, Spinal cord injury