Back to resultsA Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
Primary Purpose
Muscle Spasticity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XP19986 SR1, 10 mg BID
XP19986 SR1, 20 mg BID
XP19986 SR1, 30 mg BID
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Spasticity
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
XP19986 SR1 10 mg - Placebo
XP19986 SR1 20 mg - Placebo
XP19986 SR1 30 mg - Placebo
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Maximum Ashworth score
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00557973
Brief Title
A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
Official Title
Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XenoPort, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XP19986 SR1 10 mg - Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
XP19986 SR1 20 mg - Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
XP19986 SR1 30 mg - Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
XP19986 SR1, 10 mg BID
Other Intervention Name(s)
Sustained release Polyox WSR N750, 10 mg
Intervention Description
XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
Intervention Type
Drug
Intervention Name(s)
XP19986 SR1, 20 mg BID
Other Intervention Name(s)
Sustained release Polyox WSR N750, 20 mg
Intervention Description
XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
Intervention Type
Drug
Intervention Name(s)
XP19986 SR1, 30 mg BID
Other Intervention Name(s)
Sustained release Polyox WSR N750, 30 mg
Intervention Description
XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Ashworth score
Description
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
Time Frame
Day 17
Secondary Outcome Measure Information:
Title
Average Ashworth score
Description
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
Time Frame
Day 17
Title
Two Highest Ashworth scores
Description
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
Time Frame
Day 17
Title
Average Non-zero Ashworth Scores
Description
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
Time Frame
Day 17
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Leong, M.D.
Organizational Affiliation
XenoPort, Inc.
Official's Role
Study Director
Facility Information:
City
Downey
State/Province
California
Country
United States
City
Gilroy
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
San Jose
State/Province
California
Country
United States
City
Englewood
State/Province
Colorado
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
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