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

Phase 2

Completed

• Conditions: Muscle Spasticity
• Interventions: Drug: XP19986 SR1, 10 mg BID; Drug: XP19986 SR1, 20 mg BID; Drug: XP19986 SR1, 30 mg BID; Drug: Placebo

• Registration Number: NCT00557973
• Lead Sponsor: XenoPort, Inc.

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 Description

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.

Study Timeline

• Study First Submitted: 2007-11-12
• Study First Submitted QC: 2007-11-12
• Study First Posted: 2007-11-14
• Study Start: 2007-12
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Disposition First Submitted: 2010-09-08
• Disposition First Submitted QC: 2010-09-08
• Disposition First Posted: 2010-09-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Spasticity secondary to traumatic spinal cord injury between C-5 and T-12 spinal cord levels, at least 12 months post-injury with a stable neurological deficit

Exclusion Criteria

• Traumatic brain injury or cognitive deficit of any etiology that may influence compliance with study procedures or outcome measures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
XP19986 SR1 10 mg - Placebo	XP19986 SR1, 10 mg BID	Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 10 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
XP19986 SR1 20 mg - Placebo	XP19986 SR1, 20 mg BID	Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 20 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
XP19986 SR1 30 mg - Placebo	XP19986 SR1, 30 mg BID	Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 30 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
XP19986 SR1 20 mg - Placebo	Placebo	Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 20 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
XP19986 SR1 10 mg - Placebo	Placebo	Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 10 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
XP19986 SR1 30 mg - Placebo	Placebo	Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 30 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.

Primary Outcome Measures

Name	Time	Method
Maximum Ashworth score	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

Secondary Outcome Measures

Name	Time	Method
Average Ashworth score	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	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	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