A multi-dose efficacy and safety study of XP19986 in subjects with spasticity due to spinal cord injury

PI: Amit Jha, MD, MPH
Funded by: XenoPort, Inc.
Dates: 2008-2009
Contact: Susan Charlifue – Susie@craighospital.org 303 789 8306

The primary objective of this study is to evaluate efficacy and safety of multiple dose treatment with XP19986 SR1 (sustained release Polyox WSR N750) compared to placebo in subjects with spasticity due to spinal cord injury. The primary outcome measure in this study will be the Ashworth Scale assessment of muscle tone. Secondary outcome measures will include severity of muscle spasms, severity of pain caused by muscle spasms, nighttime awakenings due to muscle spasms, daytime sleepiness, deep tendon reflexes, and muscle strength.

The secondary objectives are to compare the efficacy and safety of three dose levels of XP19986 SR1, and to demonstrate that dosing every 12 hours with XP19986 SR1 provides sustained reduction in spasticity with acceptable safety.

Inclusion Criteria:

Male and female subjects, age 18-65, inclusive
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
Willing to discontinue and refrain from using for the duration of the study: drugs for treatment of spasticity or likely to affect spasticity.
Ability to independently travel to study center and to comply with study medication administration and recording of outcome
Able to read, write and understand English