Small Study Recruiting People with MS and Spasticity to Compare IPX056 (Extended-release Baclofen) and Immediate-release Baclofe
Posted Nov 17 2009 10:20pm
Summary: Investigators at seven sites in the United States are recruiting 28 people for a study comparing the effect of the experimental compound IPX056 (extended-release baclofen) to currently available, immediate-release baclofen in relieving spasticity and symptoms related to MS. The study is sponsored by Impax Pharmaceuticals, a division of Impax Laboratories, Inc.
Rationale: Spasticity refers to feelings of stiffness and a wide range of involuntary muscle spasms (sustained muscle contractions or sudden movements). It is one of the more common and troublesome symptoms of MS. Baclofen acts on the central nervous system to relieve spasms, cramping, and tightness of muscles caused by spasticity. This study is comparing IPX056, a new extended-release form of baclofen, to the currently available immediate-release baclofen tablets. Extended release – in which a drug is released over time – may allow for it to be taken less often. In a previous study that enrolled 173 people with MS, IPX056 significantly reduced spasticity when compared with placebo, according to a company press release dated August 7, 2008. Impax was requested to collect additional data on the safety and effectiveness of IPX056 by the U.S. Food and Drug Administration, according to a December 11, 2008 press release.
To read more and to learn where the study centers are located, click here
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