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OpenTrials
Completed

NCT Number: NCT01748695

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

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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Key information

Conditions

Neuropathic Pain Due to Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Translational Pain Research, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V158866

Drug

Placebo

Drug

Primary outcomes

  1. Mean Pain Intensity (NRS)

    Time frame: 4 Weeks

    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).

  2. Safety and Tolerability of V158866 Compared to Placebo

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Vernalis (R&D) Ltd

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2012
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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