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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-07-31

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.

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Detailed Description

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Conditions

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Neuropathic Pain Due to Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo followed by V158866

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

Group Type EXPERIMENTAL

V158866

Intervention Type DRUG

Placebo

Intervention Type DRUG

V158866 followed by Placebo

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

Group Type EXPERIMENTAL

V158866

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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V158866

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No