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COMPLETEDPhase 2NCT00557973

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

Lead sponsor: XenoPort, Inc.•11 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

XenoPort, Inc.

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.

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 21, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment37

Start dateDec 2007

Last updatedFeb 21, 2021

Condition

Muscle Spasticity

Locations shown

Downey, California

Gilroy, California

Pasadena, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2021Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions