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

NCT ID: NCT00557973

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-04-30

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.

Conditions

Muscle Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

XP19986 SR1, 10 mg BID

Intervention Type: DRUG

XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Placebo

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

XP19986 SR1, 20 mg BID

Intervention Type: DRUG

XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Placebo

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

XP19986 SR1, 30 mg BID

Intervention Type: DRUG

XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Placebo

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Sustained release Polyox WSR N750, 10 mg; Sustained release Polyox WSR N750, 20 mg; Sustained release Polyox WSR N750, 30 mg; sugar pill

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XenoPort, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Leong, M.D.

Role: STUDY_DIRECTOR

XenoPort, Inc.

Locations

Downey, California, United States

Gilroy, California, United States

Pasadena, California, United States

San Jose, California, United States

Englewood, Colorado, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Kansas City, Kansas, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Countries

United States

Other Identifiers

XP-B-065

Identifier Type: -

Identifier Source: org_study_id