Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

877

Participants

Timeline

Start Date

July 5, 2017

Primary Completion Date

January 16, 2024

Study Completion Date

January 16, 2024

Conditions
Multiple Sclerosis
Interventions
DRUG

Ponesimod

Ponesimod; Film-coated tablet; Oral use. From Day 1 to Day 14, ponesimod is gradually up-titrated until a maintenance dose of 20 mg is reached from Day 15

Trial Locations (148)

112

P. Sarajishvili Institute of Neurology, Tbilisi

114

Pineo Medical Ecosystem Ltd, Tbilisi

179

S.Khechinashvili University Hospital, Tbilisi

186

Curatio, Jsc, Tbilisi

189

Azienda Ospedaliera Sant Andrea, Roma

1002

Pauls Stradins Clinical University Hospital, Riga

1015

Latvias Juras medicinas centrs Ltd, Riga

1113

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum, Sofia

1145

Uzsoki Utcai Korhaz, Budapest

1204

Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Budapest

1307

Universitätsklinikum Carl-Gustav-Carus Dresden, Dresden

1309

Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead, Sofia

1407

Acibadem City Clinic Tokuda Hospital, Sofia

1431

St Ivan Rilski University Multiprofile Hospital For Active Treatment, Sofia

University Multiprofile Hospital for Active Treatment Alexandrovska EAD, Sofia

1606

Military Medical Academy Multiprofile Hospital for Active Treatment Sofia, Sofia

2143

Kistarcsai Flor Ferenc Korhaz, Kistarcsa

2500

Valeomed EGÉSZSÉGÜGYI KÖZPONT, Esztergom

3115

National Research Center for Radiation Medicine, Kyiv

4002

UMHAT Sveti Georgi, Plovdiv

6000

Hopital PASTEUR, Nice

8003

Hospital del Mar, Barcelona

8035

Hospital Vall d'Hebron, Barcelona

8036

Hospital Clinic I Provincial, Barcelona

9023

Petz Aladar Megyei Oktato Korhaz, Győr

10000

University Hospital Center Zagreb, Zagreb

10008

O.F. Herbachevskyi Regional Clinical Hospital, Zhytomyr

10825

Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila', Bucharest

11000

Clinical Hospital Center Zvezdara, Belgrade

Vojnomedicinska Akademija, Belgrade

11521

Naval Hospital of Athens, Athens

14001

Public Non-profit Enterprise: Chernihiv City Hospital #4 under Chernihiv City Council, Chernihiv

14029

Municipal health care institution Chernihiv Regional Hospital, Chernihiv

15125

Medical Center of Athens, Marousi

18000

University Clinical Center NIS, Niš

20520

Mehilainen NEO, Turku

21000

Medical Center Salutem LLC, Vinnytsia

22328

Institutul Clinic Fundeni, Bucharest

27607

Raleigh Neurology Associates, Raleigh

28006

Hospital Universitario de La Princesa, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

31000

Ch Osijek, Osijek

31203

Unidad de Investigacion En Salud, Chihuahua City

32174

Neurology Associates of Ormond Beach, Ormond Beach

33076

Hopital Pellegrin CHU Bordeaux, Bordeaux

33100

Suomen Terveystalo Tampere, Tampere

33612

University of South Florida, Tampa

34000

University Clinical Center Kragujevac, Kragujevac

36024

ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council', Poltava

37064

Advanced Neurosciences Institute, Franklin

41009

Hospital Universitario Virgen Macarena, Seville

41950

Hospital Vithas Nisa Sevilla, Seville

43214

Ohio Health, Columbus

44093

Hopital Nord Laennec CHU NANTES, Nantes

46027

Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb, Ternopil

46256

Josephson Wallack Munshower Neurology, PC, Indianapolis

50098

Spitalul Universitar de Urgenta Bucuresti, Bucharest

55131

Universitatsmedizin der Johannes Gutenberg Universitat Mainz, Mainz

61080

Karadeniz Teknik University Medical Faculty, Trabzon

61103

Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center', Kharkiv

61176

Kharkiv Postgrad Academy, Dept of Neurology #1 At Hosp #7, Kharkiv

63003

CHU Clermont-Ferrand - Hopital Gabriel Montpied, Clermont-Ferrand

64060

CRI Centro Regiomontano de Investigacion SC, Nuevo León

65009

Odessa National Medical University, Odesa

65691

Fakultní nemocnici Brno, Brno

67091

Nouvel Hopital Civil, Strasbourg

67100

Ospedale San Salvatore, L’Aquila

71000

University Clinicl Center Sarajevo, Sarajevo

76018

Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk

76231

VsI Respublikine Siauliu ligonine, V., Šiauliai

76493

Limited Liability Company 'Neuro Global', Ivano-Frankivsk

79000

Public Non-Profit Enterprise: Lviv City Clinical Hospital #5, Lviv

79010

Lviv Clinical Regional Hospital, Lviv

80209

Mountain View Clinical Research, Denver

91767

The Neurology Group, Pomona

92011

The Research Center of Southern California, LLC, Carlsbad

99089

Helios Klinikum Erfurt, Erfurt

117049

Clinical City Hospital #1, Moscow

127015

State Health Care Institution Of Moscow, Moscow

129128

Central Clinical Hospital N.A.Semashko, Moscow

143000

Federal Scientific Clinical Center of Physico-Chemical Medicine, Odintsovo

150003

Yaroslavl Clinical Hospital #8, Yaroslavl

170036

Tver Regional Clinical Hospital, Tver'

194354

Municipal Multi-Specialty Hospital # 2, Saint Petersburg

197022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

197110

City Clinical Hospital #31, Saint Petersburg

197376

Institute of Human Brain Ras, Saint Petersburg

197706

City Hospital# 40, Saint Petersburg

210023

Vitebsk Regional Diagnostic Center, Vitebsk

210037

Vitebsk Regional Clinical Hospital, Vitebsk

214018

Smolensk Regional Clinical Hospital, Smolensk

GUZ Novgorod Regional Clinical Hospital, Veliky Novgorod

220026

Minsk City Clinical Hospital 5, Minsk

220114

Republican Scientific Clinical Centre, Minsk

230017

Grodno University Hospital, Grodno

241033

Bryansk Regional Hospital #1, Bryansk

300723

Spitalul Clinic Judetean de Urgenta Pius Brinzeu, Timișoara

305007

State Budgetary Healthcare Institution Kursk Region Kursk Regional Clinical Hospital, Kursk

308007

St. Joseph Belgorod Regional Hospital, Belgorod

357538

City Clinical Hospital # 2, Pyatigorsk

420097

Research Medical Center Your Health, Kazan'

443095

State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin, Samara

603155

Municipal Clinical Hospital # 3, Nizhny Novgorod

614990

Perm State Medical Academy n.a. E. A. Vagner, Perm

620102

Sverdlovsk Region Clinical Hospital #1, Yekaterinburg

630007

Siberian District Medical Center of Federal Medical-Biological Agency, Novosibirsk

634050

Siberian State Medical University, Tomsk

656024

Barnaul Territorial Clinical Hospital, Barnaul

660037

Federal State Budgetary Institution, Krasnoyarsk

1304300

Ziv Medical Center, Safed

3109601

Rambam Medical Center, Haifa

7830604

Barzilai Medical Center, Ashkelon

9112001

Hadassah Medical Center, Jerusalem

T6G 1Z1

University of Alberta, Edmonton

V8R 1J8

Royal Jubilee Hospital, Victoria

K1H 8L6

Ottawa Hospital, Ottawa

J4V 2J2

Recherche Sepmus Inc., Greenfield Park

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

586 33

Nemocnice Jihlava, Jihlava

708 52

Fakultni Nemocnice Ostrava, Ostrava-Poruba

532 03

Pardubicka krajska nemocnice a s, Pardubice

128 08

Vseobecna Fakultní Nemocnice, Prague

150 06

FN Motol, Prague

415 29

Krajska zdravotni, a.s. - Nemocnice Teplice, o.z., Teplice

0160

LTD 'Aversi Clinic', T'bilisi

04275

Panakeia - Arzneimittelforschung GmbH, Leipzig

115 25

401 Military Hospital, Athens

LV-1038

Rīgas Austrumu klīniskā universitātes slimnīca, Riga

LT50161

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

85 796

Neurocentrum Bydgoszcz Sp Z O O, Bydgoszcz

80-803

Copernicus Podmiot Leczniczy Sp. z o.o, Gdansk

40 571

Neuro Centrum Centrum Terapii SM, Katowice

40 686

NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna, Katowice

05 510

Centrum Kompleksowej Rehabilitacji, Konstancin-Jeziorna

95 054

Centrum Opieki Zdrowotnej Orkan Med, Ksawerów

20-410

Indywidualna Praktyka Lekarska Prof. Konrad Rejdak, Lublin

60 355

Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Po, Poznan

61 731

Clinical Research Center sp z o o MEDIC R s k, Poznan

61 853

NZOZ NEURO KARD Ilkowski i Partnerzy Sp Partnerska Lekarzy, Poznan

51 685

WroMedica I Bielicka A Strzalkowska s c, Wroclaw

4710-243

Hospital de Braga, Braga

3000-075

Hospitais da universidade de Coimbra, Coimbra

1998-018

Hosp. Cuf Descobertas, Lisbon

4099-001

H. Santo António - Centro Hospitalar do Porto, Porto

413 45

Sahlgrenska Universitetsjukhuset, Gothenburg

113 65

Centrum för Neurologi, Stockholm

PR2 9HT

Royal Preston Hospital, Preston

M6 8HD

Salford Royal NHS Foundation Trust, Salford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY

NCT03232073 - Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis | Biotech Hunter | Biotech Hunter