Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

353

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
SpasticityMultiple Sclerosis
Interventions
DRUG

arbaclofen

40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day

DRUG

baclofen

80 mg/day as 20 mg baclofen administered orally 4 times per day

DRUG

Placebo

arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day

Trial Locations (48)

10016

Osmotica Study Site-113, New York

10019

Osmotica Study Site-141, New York

10029

Osmotica Study Site-125, New York

13790

Osmotica Study Site-115, Johnson City

14001

Osmotica Study Site 614, Chernihiv

15212

Osmotica Study Site-127, Pittsburgh

21201

Osmotica Study Site-124, Baltimore

28204

Osmotica Study Site-106, Charlotte

32174

Osmotica Study Site-119, Ormond Beach

32751

Osmotica Study Site-142, Maitland

33060

Osmotica Study Site-120, Pompano Beach

33606

Osmotica Study Site-109, Tampa

34205

Osmotica Study Site-110, Bradenton

35058

Osmotica Study Site-138, Cullman

45219

Osmotica Study Site-131, Cincinnati

46805

Osmotica Study Site-108, Fort Wayne

48104

Osmotica Study Site-101, Ann Arbor

49005

Osmotica Study Site-602, Dnipropetrovsk

49022

Osmotica Study Site-603, Dnipropetrovsk

53012

Osmotica Study Site-609, Dnipropetrovsk

60096

Osmotica Study Site-126, Northbrook

61068

Osmotica Site-605, Kharkiv

61103

Osmotica Study Site-610, Kharkiv

66214

Osmotica Study Site-116, Lenexa

76008

Osmotica Study Site-613, Ivano-Frankivsk

78229

Osmotica Study Site-112, San Antonio

80045

Osmotica Study Site-123, Aurora

83003

Osmotica Study Site-611, Donetsk

84103

Osmotica Study Site-133, Salt Lake City

88018

Osmotica Study Site-615, Uzhhorod

92845

Osmotica Site-143, Long Beach

98122

Osmotica Study Site-129, Seattle

98405

Osmotica SIte-144, Tacoma

01104

Osmotica Study Site-136, Springfield

Unknown

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

Sponsors
All Listed Sponsors
collaborator

Osmotica Pharmaceutical US LLC

INDUSTRY

lead

RVL Pharmaceuticals, Inc.

INDUSTRY