To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).
IPX056 was compared with commercially available tablets as it was designed to provide a prolonged duration of absorption to reduce dose frequency and/or to provide prolonged duration of antispasticity effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
IPX056 ER capsule containing 10 mg baclofen
Encapsulated baclofen tablet 5 mg per capsule
Placebo capsule for IPX056
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Meridien Research
Tampa, Florida, United States
Morning Stiffness Score
Time frame: 6 weeks
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Placebo encapsulated baclofen placebo tablet
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States
QUEST Research Institute
Bingham Farms, Michigan, United States
Great Falls Cllinic
Great Falls, Montana, United States
Empire Neurology, PC
Latham, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
...and 1 more locations