Multiple Sclerosis Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
The purpose of this study is to determine the effects, both good and bad, of IPX056 on subjects and their spasticity. This study will also determine the relationship between the amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine how long IPX056 affects spasticity.
The primary objective of this study is to demonstrate that IPX056 reduces spasticity,
measured by Ashworth score, in subjects with multiple sclerosis (MS). This study will also
(1) assess the correlation between pharmacokinetic (PK) and pharmacodynamic (PD) endpoints
(Ashworth score), and (2) quantify the duration of pharmacodynamic effects for IPX056 as well
as marketed baclofen tablet in subjects with Multiple Sclerosis (MS) after a single dose.
Additionally, the efficacy parameters, including Multiple Sclerosis Impact Scale (MSIS)-29,
spasm frequency and nighttime awakening score, spasticity control, morning stiffness, and
Global Assessment of Efficacy and Tolerability, will be assessed during open-label extension
period. The safety of IPX056 will be monitored throughout the study.
This study consists of 2 parts: Part I (Screening Visit & Visit 1) of the study is a
single-dose, double-blind, randomized, placebo- and active comparator-controlled, parallel
group design containing a single 12 hour PK/PD evaluation period. Part II is an optional,
approximately 9-week open-label extension study and will start during Visit 1, immediately
after Visit 1 PK/PD procedures are completed.
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