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

This study has been completed.
Sponsor:
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00557973
First received: November 12, 2007
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  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 2

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:

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 May 23, 2013