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

Purpose

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

Condition	Intervention	Phase
Muscle Spasticity	Drug: XP19986	Phase II

MedlinePlus related topics:

Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment

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

Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	36
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: XP19986 XP19986 Sustained Release (SR) Tablet or matching Placebo dosed orally, BID, for approximately 26 days with titration and taper periods
2: Experimental	Drug: XP19986 XP19986 Sustained Release (SR) Tablet or matching Placebo dosed orally, BID, for approximately 26 days with titration and taper periods
3: Experimental	Drug: XP19986 XP19986 Sustained Release (SR) Tablet or matching Placebo dosed orally, BID, for approximately 26 days with titration and taper periods

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557973

Contacts


Contact: Jeff Werkmeister, RN, MBA	949-450-8345 ext 390	Jefffrey.Werkmeister@mdsinc.com

Locations


United States, California
		Recruiting
	Gilroy, California, United States
		Recruiting
	San Jose, California, United States
		Recruiting
	Downey, California, United States
		Recruiting
	Pasadena, California, United States

United States, Colorado
		Recruiting
	Englewood, Colorado, United States

United States, Florida
		Recruiting
	Miami, Florida, United States

United States, Georgia
		Recruiting
	Atlanta, Georgia, United States

United States, Illinois
		Recruiting
	Chicago, Illinois, United States

United States, Kansas
		Recruiting
	Kansas City, Kansas, United States

United States, Michigan
		Recruiting
	Ann Arbor, Michigan, United States
		Recruiting
	Detroit, Michigan, United States

Sponsors and Collaborators

XenoPort, Inc.

Investigators


Study Director:	Michael Leong, M.D.	XenoPort, Inc.

More Information

Responsible Party:	XenoPort Inc. ( Michael Leong, Medical Director )
Study ID Numbers:	XP-B-065
First Received:	November 12, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00557973
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms

Spinal Cord Injuries

Muscle Spasticity

Muscular Diseases

Spinal Cord Diseases

Musculoskeletal Diseases

Muscle Hypertonia

Wounds and Injuries

Disorders of Environmental Origin

Central Nervous System Diseases

Neurologic Manifestations

Trauma, Nervous System

Additional relevant MeSH terms:

Neuromuscular Manifestations

Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	XenoPort, Inc.
Information provided by:	XenoPort, Inc.
ClinicalTrials.gov Identifier:	NCT00557973