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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 (Responsible Party):
Indivior Inc.
ClinicalTrials.gov Identifier:
NCT00557973
First received: November 12, 2007
Last updated: September 12, 2016
Last verified: September 2016
  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 SR1, 10 mg BID
Drug: XP19986 SR1, 20 mg BID
Drug: XP19986 SR1, 30 mg BID
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:


Further study details as provided by Indivior Inc.:

Primary Outcome Measures:
  • Maximum Ashworth score [ Time Frame: Day 17 ] [ Designated as safety issue: No ]
    Ashworth score for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose. Evaluate the difference in the primary endpoint between active and placebo treament segments at 17th day of dosing in each segment


Secondary Outcome Measures:
  • Average Ashworth score [ Time Frame: Day 17 ] [ Designated as safety issue: No ]
    This was the average of Ashworth scores obtained on Day 17 of dosing across 6 muscle groups for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose

  • Two Highest Ashworth scores [ Time Frame: Day 17 ] [ Designated as safety issue: No ]
    This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had the 2 highest Ashworth scores at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose

  • Average Non-zero Ashworth Scores [ Time Frame: Day 17 ] [ Designated as safety issue: No ]
    This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had a non-zero Ashworth score at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose


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: XP19986 SR1 10 mg - Placebo
Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 10 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
Drug: XP19986 SR1, 10 mg BID
XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
Other Name: Sustained release Polyox WSR N750, 10 mg
Drug: Placebo
Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.
Other Name: sugar pill
Experimental: XP19986 SR1 20 mg - Placebo
Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 20 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
Drug: XP19986 SR1, 20 mg BID
XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
Other Name: Sustained release Polyox WSR N750, 20 mg
Drug: Placebo
Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.
Other Name: sugar pill
Experimental: XP19986 SR1 30 mg - Placebo
Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 30 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
Drug: XP19986 SR1, 30 mg BID
XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
Other Name: Sustained release Polyox WSR N750, 30 mg
Drug: Placebo
Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.
Other Name: sugar pill

Detailed Description:
This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury. Three cohorts of subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30 mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment segment. Each subject serves as their own control in this cross-over study.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Indivior Inc.
Investigators
Study Director: Michael Leong, M.D. XenoPort, Inc.
  More Information

Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT00557973     History of Changes
Other Study ID Numbers: XP-B-065 
Study First Received: November 12, 2007
Last Updated: September 12, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Cord Injuries
Muscle Spasticity
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Arbaclofen placarbil
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016