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

Sponsor

XenoPort, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00557973

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: sugar pill

Arm

Intervention/Treatment

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 Names:

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 Names:

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 Names:

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 Names:

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 Names:

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 Names:

sugar pill

Outcome Measures

Primary Outcome Measures

Maximum Ashworth score [Day 17]
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 [Day 17]
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 [Day 17]
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 [Day 17]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Downey	California	United States
2	Gilroy	California	United States
3	Pasadena	California	United States
4	San Jose	California	United States
5	Englewood	Colorado	United States
6	Miami	Florida	United States
7	Atlanta	Georgia	United States
8	Chicago	Illinois	United States
9	Kansas City	Kansas	United States
10	Ann Arbor	Michigan	United States
11	Detroit	Michigan	United States

Sponsors and Collaborators

XenoPort, Inc.

Investigators

Study Director: Michael Leong, M.D., XenoPort, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

XenoPort, Inc.

ClinicalTrials.gov Identifier:

NCT00557973

Other Study ID Numbers:

XP-B-065

First Posted:

Nov 14, 2007

Last Update Posted:

Feb 21, 2021

Last Verified:

Feb 1, 2021

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2021