To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
arbaclofen placarbil 15 mg BID
Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
arbaclofen placarbil 30 mg BID
Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point)
numerical score
Time frame: 10-weeks
Patient Global Impression of Change (PGIC) score
numerical score
Time frame: 10-weeks
Change in the overall Modified PRISM score
Variables
Time frame: Weeks 4, 6, 10
Change in weekly average severity of pain score associated with muscle spasm.
numerical score
Time frame: Week 10
Change in weekly average VAS score of sleep quality
numerical score
Time frame: Week 10
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arbaclofen placarbil 45 mg BID
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Lake Barrington, Illinois, United States
...and 18 more locations