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

XenoPort

Status and phase: Completed; Phase 2

Conditions: Muscle Spasticity

Treatments: Drug: Placebo; Drug: XP19986 SR1, 30 mg BID; Drug: XP19986 SR1, 10 mg BID; Drug: XP19986 SR1, 20 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT00557973

XP-B-065

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 3 patient groups

XP19986 SR1 10 mg - Placebo

Experimental group

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.

Treatment:

Drug: XP19986 SR1, 10 mg BID

Drug: Placebo

XP19986 SR1 20 mg - Placebo

Experimental group

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.

Treatment:

Drug: XP19986 SR1, 20 mg BID

Drug: Placebo

XP19986 SR1 30 mg - Placebo

Experimental group

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.

Treatment:

Drug: Placebo

Drug: XP19986 SR1, 30 mg BID