NCT00488839 - IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis | Biotech Hunter

Enrollment

173

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions

Multiple Sclerosis

Interventions

DRUG

IPX056 20 mg

IPX056 Extended Release capsule containing 20 mg baclofen

DRUG

IPX056 40 mg

IPX056 Extended Release capsule containing 40 mg baclofen

DRUG

Encapsulated Baclofen 20 mg

Baclofen 20mg tablet was encapsulated for blinding.

DRUG

Placebo Baclofen Tablet

Placebo capsule encapsulated placebo Baclofen tablet

DRUG

IPX056 10 mg

IPX056 Extended Release capsule containing 10 mg baclofen

DRUG

IPX056 30 mg

IPX056 Extended Release capsule containing 30 mg baclofen

DRUG

IPX056 35 mg

IPX056 Extended Release capsule containing 35 mg baclofen

DRUG

Placebo IPX056 20 mg

Placebo capsule for IPX056 20 mg

DRUG

Placebo IPX056 40 mg

Placebo capsule for IPX056 40 mg

Trial Locations (31)

10617

West-Tallinn Central Hospital, Tallinn

11501

Winthrop University Hospital, Mineola

14029

Chernihiv Regional Hospital Department of Neurology, Chernihiv

19013

Crozer Chester Medical Center, Upland

21005

Vinnytsya Regional Psychoneurological Hospital, Vinnytsia

23298

Virginia Commonwealth University Medical Center, Richmond

30327

MS Center of Atlanta, Atlanta

33021

Sunrise Clinical Research, Hollywood

33606

Meridien Research, Tampa

36024

Neurology department of Ukraine medical stomatological akademy, Poltava

46514

Elkhardt Clinic, Elkhart

48109

General Clinical Research Center 7A, Ann Arbor

49027

Neurology and Neurosurgery Dpt., Postgraduation training faculty, Dnipropetrovsk State medical Academy, Dnipropetrovsk

49684

Northern Michigan Neurology, Traverse City

61068

Institue of Neruology, Psychiatry and Narcology of AMS of Ukraine, Kharkiv

61637

OSF Saint Francis Medical Center, Peoria

63117

Medex Healthcare Research, Inc., Saint Louis

65025

Odessa Regional Clinical Hospital, Odesa

66214

MidAmerica Neuroscience Institute, Lenexa

72201

OrthoArkansas, P. A., Little Rock

OrthoArkansas, P.A., Little Rock

78229

Integra Clinical Research, San Antonio

79410

Bhupesh Dihenia, Lubbock

80919

Patricia Fodor, Colorado Springs

85741

Northwest NeuroSpecialists, Tucson

01104

Springfield Neurology, Springfield

05201

Neurological Research Center, Bennington

H3A 2B4

Montreal Neurological Institute and Hospital, Montreal

t2n 2t9

Foothills Medical Centre, MS Clinic, SSB, Calgary

Unknown

Vecmilgravis Hospital, Latvian Maritime Medicine Center, Riga

03110

Department of nervous system demyelization diseases of City Clinical Hospital, Kyiv