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

• ClinicalTrials.gov Identifier: NCT01748695
• Recruitment Status: Completed
• First Posted: December 12, 2012
• Results First Posted: April 11, 2017
• Last Update Posted: April 11, 2017
• Sponsor: Brigham and Women's Hospital
• Collaborator: Vernalis (R&D) Ltd
• Information provided by (Responsible Party): Christine N. Sang, MD, MPH, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: December 11, 2012
• First Posted Date: December 12, 2012
• Results First Submitted Date: December 21, 2016
• Results First Posted Date: April 11, 2017
• Last Update Posted Date: April 11, 2017
• Study Start Date: June 2013
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2017)

• 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).
• 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.

Original Primary Outcome Measures (submitted: December 11, 2012)

• Change from baseline in mean pain intensity scores on the NRS. [ Time Frame: 4 Weeks ]
  The primary efficacy endpoint will be the comparison of the overall pain intensity on the NRS for the last 7 days of each treatment period. (V158866 compared to placebo)
• Safety and tolerability of V158866 compared to placebo [ Time Frame: 4 weeks ]
  Safety and tolerability measured by: Adverse events, Columbia Suicide Severity Rating Scale change from baseline, Vital signs change from baseline, 12-lead ECG change from baseline, Beck Depression Inventory change from baseline, Laboratory safety tests changes from baseline, ARC Inventory - marijuana change from baseline, RBANS change from baseline

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: December 11, 2012)

• Gracely pain scores [ Time Frame: 4 weeks ]
  Gracely pain scores will be compared between V158866 and placebo treatment.
• Sleep interference [ Time Frame: 4 weeks ]
  Sleep interference scores will be compared between treatment with V158866 and placebo.
• Quantitative Sensory Testing [ Time Frame: 4 weeks ]
  Quantitative Sensory Testing parameters will be compared between treatment with V158866 and placebo

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
• Official 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Neuropathic Pain Due to Spinal Cord Injury

Intervention

• Drug: V158866
• Drug: Placebo

Study Arms

• Experimental: Placebo followed by V158866
  Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
  Interventions:

  • Drug: V158866
  • Drug: Placebo
• Experimental: V158866 followed by Placebo
  V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks
  Interventions:

  • Drug: V158866
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 10, 2017): 25
• Original Estimated Enrollment (submitted: December 11, 2012): 36
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01748695
• Other Study ID Numbers: V158866-2Pa-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Christine N. Sang, MD, MPH, Brigham and Women's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Brigham and Women's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Vernalis (R&D) Ltd

Investigators

• Principal Investigator: Christine N Sang, MD, MPH; Brigham and Women's Hospital

• PRS Account: Brigham and Women's Hospital
• Verification Date: April 2017