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

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

This study is currently recruiting participants.

Study NCT00557973. Last updated on May 1, 2008. Information provided by XenoPort, Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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 Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment

Primary Outcome Measure ^†

Assessment of muscle tone [ Time Frame: Treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Severity and pain associated with muscle spasms; muscle strength and tendon reflexes; sleep symptoms [ Time Frame: Treatment period ] [ Designated as safety issue: No ]

Condition ^†

Muscle Spasticity

Intervention ^†

Drug: XP19986

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

December 2007

Completion Date

December 2008

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Jeff Werkmeister, RN, MBA

949-450-8345 ext 390

Jefffrey.Werkmeister@mdsinc.com

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00557973

Organization ID

XP-B-065

Secondary IDs ^††

Study Sponsor ^†

XenoPort, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Michael Leong, M.D.

XenoPort, Inc.

Information Provided By

XenoPort, Inc.

Verification Date

May 2008

First Received Date ^†

November 12, 2007

Last Updated Date

May 1, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.