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

This study is currently recruiting participants.
Verified by XenoPort, Inc., May 2008

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

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




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