Overview

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

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indivior Inc.
XenoPort, Inc.
Treatments:
Arbaclofen placarbil
Baclofen
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