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

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

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, 10 mg BID Drug: XP19986, 20 mg BID Drug: XP19986, 30 mg BID	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:

Assessment of muscle tone [ Time Frame: Day 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severity and pain associated with muscle spasms; muscle strength and tendon reflexes; sleep symptoms [ Time Frame: Day 17 ] [ Designated as safety issue: No ]

Enrollment:	37
Study Start Date:	December 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: XP19986, 10 mg BID XP19986 Sustained Release (SR) Tablet or matching Placebo dosed orally, BID, for approximately 26 days with titration and taper periods
Experimental: 2	Drug: XP19986, 20 mg BID XP19986 Sustained Release (SR) Tablet or matching Placebo dosed orally, BID, for approximately 26 days with titration and taper periods
Experimental: 3	Drug: XP19986, 30 mg BID 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

Locations

United States, California

Downey, California, United States

Gilroy, California, United States

Pasadena, California, United States

San Jose, California, United States
United States, Colorado

Englewood, Colorado, United States
United States, Florida

Miami, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Illinois

Chicago, Illinois, United States
United States, Kansas

Kansas City, Kansas, United States
United States, Michigan

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Sponsors and Collaborators

XenoPort, Inc.

Investigators

Study Director:

Michael Leong, M.D.

XenoPort, Inc.

More Information

No publications provided

Responsible Party:	Michael Leong, Medical Director, XenoPort Inc.
ClinicalTrials.gov Identifier:	NCT00557973 History of Changes
Other Study ID Numbers:	XP-B-065
Study First Received:	November 12, 2007
Last Updated:	September 10, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Muscle Spasticity
Spinal Cord Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2012