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NCT Number: NCT00557973

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

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

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Key information

Conditions

Muscle Spasticity Muscle Hypertonia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Downey, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XP19986 SR1, 10 mg BID

Drug

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

Other names: Sustained release Polyox WSR N750, 10 mg

XP19986 SR1, 20 mg BID

Drug

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

Other names: Sustained release Polyox WSR N750, 20 mg

XP19986 SR1, 30 mg BID

Drug

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

Other names: Sustained release Polyox WSR N750, 30 mg

Placebo

Drug

Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.

Other names: sugar pill

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

XenoPort, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 14, 2007
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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