NCT01748695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 11, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

December 11, 2012

Results QC Date

December 21, 2016

Last Update Submit

April 10, 2017

Conditions

Neuropathic Pain Due to Spinal Cord Injury

Keywords

Neuropathic painSpinal cord injury

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Placebo followed by V158866

EXPERIMENTAL

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

Drug: V158866Drug: Placebo

V158866 followed by Placebo

EXPERIMENTAL

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

Drug: V158866Drug: Placebo

Interventions

V158866DRUG
Placebo followed by V158866V158866 followed by Placebo
PlaceboDRUG
Placebo followed by V158866V158866 followed by Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Translational Pain Research, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

NeuralgiaSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Christine N. Sang, Director of Translational Pain Research
Organization
Brigham and Women's Hospital
csang@partners.org
617-525-7246

Study Officials

  • Christine N Sang, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Christine Sang

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 12, 2012

Study Start

June 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 11, 2017

Results First Posted

April 11, 2017

Record last verified: 2017-04

Locations

US(1)