353
Participants
Start Date
November 30, 2012
Primary Completion Date
April 30, 2014
Study Completion Date
April 30, 2014
arbaclofen
40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day
baclofen
80 mg/day as 20 mg baclofen administered orally 4 times per day
Placebo
arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day
Osmotica Study Site-113, New York
Osmotica Study Site-141, New York
Osmotica Study Site-125, New York
Osmotica Study Site-115, Johnson City
Osmotica Study Site 614, Chernihiv
Osmotica Study Site-127, Pittsburgh
Osmotica Study Site-124, Baltimore
Osmotica Study Site-106, Charlotte
Osmotica Study Site-119, Ormond Beach
Osmotica Study Site-142, Maitland
Osmotica Study Site-120, Pompano Beach
Osmotica Study Site-109, Tampa
Osmotica Study Site-110, Bradenton
Osmotica Study Site-138, Cullman
Osmotica Study Site-131, Cincinnati
Osmotica Study Site-108, Fort Wayne
Osmotica Study Site-101, Ann Arbor
Osmotica Study Site-602, Dnipropetrovsk
Osmotica Study Site-603, Dnipropetrovsk
Osmotica Study Site-609, Dnipropetrovsk
Osmotica Study Site-126, Northbrook
Osmotica Site-605, Kharkiv
Osmotica Study Site-610, Kharkiv
Osmotica Study Site-116, Lenexa
Osmotica Study Site-613, Ivano-Frankivsk
Osmotica Study Site-112, San Antonio
Osmotica Study Site-123, Aurora
Osmotica Study Site-611, Donetsk
Osmotica Study Site-133, Salt Lake City
Osmotica Study Site-615, Uzhhorod
Osmotica Site-143, Long Beach
Osmotica Study Site-129, Seattle
Osmotica SIte-144, Tacoma
Osmotica Study Site-136, Springfield
Osmotica Study Site-509, Pyatigorsk
Osmotica Study Site-510, Tonnel’nyy
Osmotica Site-511, Krasnoyarsk
Osmotica Study Site-508, Krasnoyarsk
Osmotica Study Site-510, Krasnoyarsk
Osmotica Study Site-501, Moscow
Osmotica Study Site-502, Moscow
Osmotica Study Site-503, Saint Petersburg
Osmotica Study Site-505, Saint Petersburg
Osmotica Study Site-507, Saint Petersburg
Osmotica Study Site-506, Sestroretsk
Osmotica Study Site-604, Kharkiv
Osmotica Study Site-606, Lviv
Osmotica Study Site-608, Odesa
Collaborators (1)
Osmotica Pharmaceutical US LLC
INDUSTRY
RVL Pharmaceuticals, Inc.
INDUSTRY