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

XenoPort, Inc.37 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Muscle Spasticity

Interventions

XP19986 SR1, 10 mg BIDDRUG

XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

XP19986 SR1, 20 mg BIDDRUG

XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

XP19986 SR1, 30 mg BIDDRUG

XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Downey, California, United States

Unnamed facility

Gilroy, California, United States

Unnamed facility

Pasadena, California, United States

Unnamed facility

San Jose, California, United States

Outcomes

Primary Outcomes

Maximum Ashworth score

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

Time frame: Day 17

Secondary Outcomes

Average Ashworth score

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

Time frame: Day 17

Two Highest Ashworth scores

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

Time frame: Day 17

Average Non-zero Ashworth Scores

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

Time frame: Day 17

Data from ClinicalTrials.gov

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