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

Sponsored by:	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	Phase II

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

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: 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
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (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

Locations

United States, California

Gilroy, California, United States

San Jose, California, United States

Downey, California, United States

Pasadena, 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:	XenoPort Inc. ( Michael Leong, Medical Director )
Study ID Numbers:	XP-B-065
Study First Received:	November 12, 2007
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00557973 History of Changes
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
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Spinal Cord Injuries
Signs and Symptoms
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations

ClinicalTrials.gov processed this record on July 02, 2009