Jul 14, 2009
MS Trial Alert: Small Study Recruiting People with MS and Spasticity to Compare IPX056 (Extended-release Baclofen) and Immediate-release Baclofen
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.
Eligibility and Details: Participants should be at least 18 years old, with MS, and have been taking baclofen tablets three times daily (15 mg to 80 mg total daily dose) for at least 4 weeks, with resulting improvements in spasticity.
Participants will take individually adjusted doses of either IPX056 twice a day or immediate-release baclofen three times a day for six weeks. The primary endpoints being evaluated are scores on scales measuring morning stiffness and nighttime awakening.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you. Sites appear in the study listing in our trials recruitment database, and are listed below:
Florida
Meridien Research, Tampa FL
lfucheck@meridienresearch.net, (813) 87-STUDY or (813) 877-8839
Indiana
Allied Physicians Inc., Ft. Wayne, IN
Crista Ellias, (260) 460-3257, celias@fwnc.com
Kansas
MidAmerica Neuroscience Institute, Lenexa, KS
Laurie, (913) 894-1500 ext. 166, lkemble@neurokc.com
Michigan
Quest Research Institute, Bingham Farms, MI
(888) QUEST24 or (888) 783-7824, barb@questri.com
Montana
Great Falls Clinic, LLP, Great Falls, MT
(406) 268-3955, connie.winner@gfclinic.com
New York
Empire Neurology, PC, Latham, NY
Judy Button, jbutton@tristateneuro.com
Texas
Central Texas Neurology Consultants, Round Rock, TX
Lori Mayer, (512) 218-1222, centexms@gmail.com