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

Tracking Information

First Received Date ^ICMJE

November 12, 2007

Last Updated Date

July 1, 2009

Start Date ^ICMJE

December 2007

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Assessment of muscle tone [ Time Frame: Treatment period ]

Change History

Complete list of historical versions of study NCT00557973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Severity and pain associated with muscle spasms; muscle strength and tendon reflexes; sleep symptoms [ Time Frame: Treatment period ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Muscle Spasticity

Intervention ^ICMJE

Drug: XP19986

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00557973

Responsible Party

Michael Leong, Medical Director, XenoPort Inc.

Study ID Numbers ^ICMJE

XP-B-065

Study Sponsor ^ICMJE

XenoPort, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Michael Leong, M.D.

XenoPort, Inc.

Information Provided By

XenoPort, Inc.

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP