Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

PHASE2TerminatedINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Multiple Sclerosis
Interventions
DRUG

ONO-4641

Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.

Trial Locations (70)

8000

Brugge Clinical Site 203, Bruges

La Louviere Clinical Site 201, La Louvière

14642

Rochester Clinical Site 108, Rochester

15006

Praha 5 Clinical Site 213, Prague

17007

Girona Clinical Site 254, Girona

19104

Philadelphia Clinical Site 120, Philadelphia

21005

Vinnytsya Clinical Site 342, Vinnytsia

27607

Raleigh Clinical Site 103, Raleigh

28201

Charlotte Clinical Site 125, Charlotte

32174

Ormond Beach Clinical Site 129, Ormond Beach

34243

Sarasota Clinical Site 116, Sarasota

35033

Marburg Clinical Site 228, Marburg

35385

Glessen Clinical Site 221, Glessen

37934

Knoxville Clinical Site 134, Knoxville

41071

Sevilla Clinical Site 256, Seville

44320

Akron Clinical Site 112, Akron

46202

Indianapolis Clinical Site 121, Indianapolis

46805

Fort Wayne Clinical Site 111, Fort Wayne

48013

Bilbao Clinical Site 255, Bilbao

48202

Detroit Clinical Site 104, Detroit

48334

Farmington Hills Clinical Site 126, Farmington Hills

49027

Dnipropetrovsk Clinical Site 341, Dnipropetrovsk

53203

Pardubice Clinical Site 211, Pardubice

60062

Northbrook Clinical Site 135, Northbrook

72076

Tubingen Clinical Site 226, Tübingen

78681

Round Rock Clinical Site 107, Round Rock

80045

Aurora Clinical Site 132, Aurora

80528

Fort Collins Clinical Site 123, Fort Collins

85705

Tucson Clinical Site 133, Tucson

87131

Albuquerque Clinical Site 106, Albuquerque

107150

Moscow Clinical Site 332, Moscow

Nizhniy Novgorod Clinical Site 321, Nizhny Novgorod

121356

Moscow Clinical Site 330, Moscow

194354

St. Petersburg Clinical Site 325, Saint Petersburg

420103

Kazan Clinical Site 333, Kazan'

443095

Samara Clinical Site 329, Samara

450005

Ufa Clinical Site 326, Ufa

630091

Novosibirsk Clinical Site 324, Novosibirsk

06824

Fairfield Clinical Site 110, Fairfield

03756

Lebanon Clinical Site 115, Lebanon

V6T 2B5

Vancouver Clinical Site 131, Vancouver

Unknown

Gatineau Clinical Site 114, Gatineau

Kanto Region Clinical Site 404, Kanto

Kanto Region Clinical Site 405, Kanto

Kanto Region Clinical Site 406, Kanto

Kanto Region Clinical Site 409, Kanto

Kinki Region Clinical Site 401, Kinki

Kinki Region Clinical Site 407, Kinki

Kinki Region Clinical Site 408, Kinki

Tohoku Region Clinical Site 403, Tōhoku

Tohoku Region Clinical Site 410, Tōhoku

J4V2J2

Greenfield park Clinical Site 109, Greenfield Park

H1T2M4

Montreal Clinical Site 101, Montreal

H9X3Z9

Montreal Clinical Site 102, Montreal

775 20

Olomouc Clinical Site 212, Olomouc

04103

Leipzig Clinical Site 229, Leipzig

115 29

Athens Clinical Site 243, Athens

15-402

Bialystok Clinical Site 305, Bialystok

41-250

Czeladz Clinical Site 303, Czeladź

80-803

Gdansk Clinical Site 302, Gdansk

40-594

Katowice Clinical Site 309, Katowice

31-530

Krakow Clinical Site 307, Krakow

90-153

Lodz Clinical Site 306, Lodz

62-064

Plewiska Clinical Site 304, Plewiska

04-749

Warszawa Clinical Site 308, Warsaw

08025

Barcelona Clinical Site 252, Barcelona

Barcelona Clinical Site 253, Barcelona

08907

Hospitalet de Llobregat Clinical Site 251, L'Hospitalet de Llobregat

03110

Kyiv Clinical Site 344, Kyiv

Lviv Clinical Site 343, Lviv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

collaborator

Ono Pharmaceutical Co. Ltd

INDUSTRY

lead

EMD Serono

INDUSTRY