Clinical Trial: A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury

Brief Summary: The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury

Detailed Summary: This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury. Three cohorts of subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30 mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment segment. Each subject serves as their own control in this cross-over study.
Sponsor: Indivior Inc.

Current Primary Outcome: Maximum Ashworth score [ Time Frame: Day 17 ]

Ashworth score for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose. Evaluate the difference in the primary endpoint between active and placebo treament segments at 17th day of dosing in each segment


Original Primary Outcome: Assessment of muscle tone [ Time Frame: Treatment period ]

Current Secondary Outcome:

  • Average Ashworth score [ Time Frame: Day 17 ]
    This was the average of Ashworth scores obtained on Day 17 of dosing across 6 muscle groups for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose
  • Two Highest Ashworth scores [ Time Frame: Day 17 ]
    This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had the 2 highest Ashworth scores at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose
  • Average Non-zero Ashworth Scores [ Time Frame: Day 17 ]
    This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had a non-zero Ashworth score at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose


Original Secondary Outcome: Severity and pain associated with muscle spasms; muscle strength and tendon reflexes; sleep symptoms [ Time Frame: Treatment period ]

Information By: Indivior Inc.

Dates:
Date Received: November 12, 2007
Date Started: December 2007
Date Completion:
Last Updated: September 12, 2016
Last Verified: September 2016