One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

January 31, 2015

Conditions
Multiple SclerosisSpasticity
Interventions
DRUG

arbaclofen

Arbaclofen ER tablets, 20 mg, 30 mg and 40 mg

Trial Locations (35)

11803

Osmotica Study Site-161, Plainview

19107

Osmotica Study Site-163, Philadelphia

22182

Osmotica Study Site-166, Vienna

27262

Osmotica Study Site-157, High Point

27607

Osmotica Study Site-155, Raleigh

28203

Osmotica Study Site-151, Charlotte

28401

Osmotica Study Site-152, Wilmington

33060

Osmotica Study Site-178, Pompano Beach

33606

Osmotica Study Site-170, Tampa

34205

Osmotica Study Site-173, Bradenton

36011

Osmotica Study Site-657, Poltava

37064

Osmotica Study Site-162, Franklin

45417

Osmotica Study Site-156, Dayton

48104

Osmotica Study Site-175, Ann Arbor

49022

Osmotica Study Site-653, Dnipropetrovsk

53012

Osmotica Study Site-655, Dnipropetrovsk

60096

Osmotica Study Site-179, Northbrook

61103

Osmotica Study Site-654, Kharkiv

66214

Osmotica Study Site-174, Lenexa

78229

Osmotica Study Site-171, San Antonio

79010

Osmotica Study Site-656, Lviv

83003

Osmotica Study Site-651, Donetsk

85032

Osmotica Study Site-158, Phoenix

85234

Osmotica Study Site-154, Gilbert

90505

Osmotica Study Site-164, Torrance

Osomtica Study Site-164, Torrance

91105

Osmotica Study Site-165, Pasadena

107150

Osmotica Study Site-557, Moscow

127018

Osmotica Study Site-556, Moscow

190000

Osmotica Study Site-551, Saint Petersburg

197706

Osmotica Study Site-560, Sestroretsk

357034

Osmotica Study Site-555, Tonnel'nyy

660022

Osmotica Study Site-554, Krasnoyarsk

Unknown

Osmotica Study Site-552, Krasnoyarsk

Osmotica Study Site-553, Pyatigorsk

Sponsors
All Listed Sponsors
collaborator

Osmotica Pharmaceutical US LLC

INDUSTRY

lead

RVL Pharmaceuticals, Inc.

INDUSTRY