MedPath

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Phase 3
Recruiting
Conditions
Relapsing Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
Interventions
Drug: Tolebrutinib
Drug: Placebo
Drug: Teriflunomide
Registration Number
NCT06372145
Lead Sponsor
Sanofi
Brief Summary

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]).

SUBSTUDY: ToleDYNAMIC substudy

Detailed Description

Participants with relapsing MS from the Phase 2b LTS16004 parent study will continue open-label (OL) tolebrutinib.

All participants from the Phase 3 parent studies (EFC16033, EFC16034, EFC16645, and EFC16035) will learn which treatment they received in the parent study:

* If from one of the Phase 3 relapsing MS studies and on teriflunomide, an accelerated elimination procedure or a 3-month washout period is required prior to starting OL tolebrutinib. If on teriflunomide, and benefiting and recommended by the Investigator, the participant may opt to continue teriflunomide outside of the LTS17043 study, if clinically appropriate. If on tolebrutinib, the participant will continue tolebrutinib.

* All participants from one of the Phase 3 progressive MS studies will start OL tolebrutinib.

* If a participant already started OL tolebrutinib in the Phase 3 parent study this will be continued.

* RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.

The treatment duration per participant will be approximately 3 years of OL tolebrutinib.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
2500
Inclusion Criteria
  • Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.

OR

  • The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.

ToleDYNAMIC Substudy: Inclusion criteria are those of the main study

Read More
Exclusion Criteria
  • Participants are excluded from the study if any of the following criteria apply:
  • The participant is at risk for or has a persistent chronic, active (including fever higher than 38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator
  • For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection
  • Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit
  • Current alcohol intake equal to or exceeding the following at the opt-in visit: more than 2 drinks per day for men and more than 1 drink per day for women
  • Abnormal ECG during the opt-in visit considered in the Investigator's judgment to be clinically significant, such as QTcF >500 msec, in the context of this study.
  • A bleeding disorder, known platelet dysfunction, abnormal platelet count (<100,000/microliter), history of significant bleeding event or other conditions and planned procedures that may predispose the participant to excessive bleeding during the study, as judged by the Investigator.
  • For participants initiating OL tolebrutinib in the LTS17043 study: Confirmed unblinding visit (RMS) or opt-in visit (PMS) alanine aminotransferase (ALT) more than 1.5 × upper limit of normal (ULN) OR aspartate aminotransferase (AST) more than 1.5 × ULN OR alkaline phosphatase more than 2 × ULN (unless caused by non-liver-related disorder or explained by a stable chronic liver disorder) OR total bilirubin more than 1.5 × ULN (unless due to Gilbert syndrome or non-liver-related disorder).
  • Acute liver disease, cirrhosis, chronic liver disease (unless considered stable for more than 6 months).
  • Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial results difficult or that would put the patient at risk by participating in the trial, as judged by the Investigator.
  • The participant is receiving treatment during the study period with drugs not permitted by the study protocol, including potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes.

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

ToleDYNAMIC Substudy: Exclusion criteria are those of the main study

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
TolebrutinibTolebrutinib* Participants will receive OL tolebrunitib 60 mg once daily. * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.
TolebrutinibPlacebo* Participants will receive OL tolebrunitib 60 mg once daily. * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.
TeriflunomidePlacebo* participants will receive teriflunomide 14 mg daily * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment (either tolebrutinib or teriflunomide) as per their randomization from the parent study. If unblinded to teriflunomide parent study treatment assignment, these RMS participants will continue teriflunomide in the LTS17043 study.
TeriflunomideTeriflunomide* participants will receive teriflunomide 14 mg daily * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment (either tolebrutinib or teriflunomide) as per their randomization from the parent study. If unblinded to teriflunomide parent study treatment assignment, these RMS participants will continue teriflunomide in the LTS17043 study.
Primary Outcome Measures
NameTimeMethod
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuationFrom baseline until the End of study approximately 3 years per participant
Number of Participants with Potentially clinically significant abnormalities (PCSAs)From baseline until the End of study approximately 3 years per participant

Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs and safety findings on MRI during the study period.

Secondary Outcome Measures
NameTimeMethod
Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studiesFrom baseline until the End of study approximately 3 years per participant

Time to onset is defined as a sustained increase from baseline EDSS (pivotal trial) of:

* RMS: ≥1.5 points when the baseline score is 0, ≥1.0 point when the baseline score is 0.5 to ≤5.5 or ≥0.5 point when the baseline score is \>5.5

* PPMS: ≥1.0 point when the baseline score is ≤5.5 or ≥0.5 point when the baseline score is \>5.5

* NRSPMS: ≥1.0 point when the baseline score is ≤5.0 or ≥0.5 point when the baseline score is \>5.0

Annualized Relapse Rate (ARR) for RMS onlyFrom baseline until the End of study approximately 3 years per participant

ARR during the OL treatment period assessed by confirmed protocol-defined relapses

Number of new and/or enlarging T2-hyperintense lesions per yearFrom baseline until the End of study approximately 3 years per participant
Change from baseline in total volume of T2-hyperintense lesionsFrom baseline until the End of study approximately 3 years per participant
ToleDYNAMIC substudy Change from baseline in biomarkersFrom baseline until 12 months per participant

Trial Locations

Locations (312)

Investigational Site Number : 0360001

🇦🇺

Saint Leonards, New South Wales, Australia

Investigational Site Number : 0360006

🇦🇺

Kent Town, South Australia, Australia

Investigational Site Number : 0360007

🇦🇺

Melbourne, Victoria, Australia

Investigational Site Number : 0400003

🇦🇹

Innsbruck, Austria

Investigational Site Number : 0400004

🇦🇹

Linz, Austria

Investigational Site Number : 0400002

🇦🇹

Vienna, Austria

Investigational Site Number : 0560005

🇧🇪

Bruges, Belgium

Investigational Site Number : 0560007

🇧🇪

Brussels, Belgium

Investigational Site Number : 0560004

🇧🇪

Gent, Belgium

Investigational Site Number : 0560006

🇧🇪

Leuven, Belgium

Investigational Site Number : 0560008

🇧🇪

Liège, Belgium

Investigational Site Number : 0560001

🇧🇪

Overpelt, Belgium

Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760002

🇧🇷

Curitiba, Paraná, Brazil

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

🇧🇷

Porto Alegre, Rio Grande Do Sul, Brazil

CPQuali Pesquisa Clinica - São Paulo- Site Number : 0760007

🇧🇷

São Paulo, Brazil

Investigational Site Number : 1000002

🇧🇬

Pleven, Bulgaria

Investigational Site Number : 1000005

🇧🇬

Plovdiv, Bulgaria

Investigational Site Number : 1000004

🇧🇬

Sofia, Bulgaria

Investigational Site Number : 1000008

🇧🇬

Sofia, Bulgaria

Investigational Site Number : 1000001

🇧🇬

Sofia, Bulgaria

Investigational Site Number : 1000006

🇧🇬

Sofia, Bulgaria

Investigational Site Number : 1000009

🇧🇬

Sofia, Bulgaria

Investigational Site Number : 1240002

🇨🇦

Edmonton, Alberta, Canada

Investigational Site Number : 1240017

🇨🇦

Burnaby, British Columbia, Canada

Investigational Site Number : 1249901

🇨🇦

Vancouver, British Columbia, Canada

Investigational Site Number : 1240012

🇨🇦

Hamilton, Ontario, Canada

Investigational Site Number : 1240003

🇨🇦

Ottawa, Ontario, Canada

Investigational Site Number : 1240006

🇨🇦

Gatineau, Quebec, Canada

Investigational Site Number : 1240021

🇨🇦

Lévis, Quebec, Canada

Investigational Site Number : 1240004

🇨🇦

Montreal, Quebec, Canada

Investigational Site Number : 1240015

🇨🇦

Montreal, Quebec, Canada

Investigational Site Number : 1240007

🇨🇦

Sherbrooke, Quebec, Canada

Investigational Site Number : 1240001

🇨🇦

Quebec, Canada

Investigational Site Number : 1520002

🇨🇱

Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520005

🇨🇱

Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520001

🇨🇱

Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520003

🇨🇱

Santiago, Chile

Investigational Site Number : 1560009

🇨🇳

Beijing, China

Investigational Site Number : 1560006

🇨🇳

Beijing, China

Investigational Site Number : 1560023

🇨🇳

Beijing, China

Investigational Site Number : 1560025

🇨🇳

Beijing, China

Investigational Site Number : 1560004

🇨🇳

Changchun, China

Investigational Site Number : 1560015

🇨🇳

Changsha, China

Investigational Site Number : 1560005

🇨🇳

Chengdu, China

Investigational Site Number : 1560019

🇨🇳

Chongqing, China

Investigational Site Number : 1560035

🇨🇳

Fuzhou, China

Investigational Site Number : 1569903

🇨🇳

Guangzhou, China

Investigational Site Number : 1560027

🇨🇳

Hohhot, China

Investigational Site Number : 1560014

🇨🇳

Jiazhuang, China

Investigational Site Number : 1560044

🇨🇳

Nanjing, China

Investigational Site Number : 1560042

🇨🇳

Nanjing, China

Investigational Site Number : 1569901

🇨🇳

Shanghai, China

Investigational Site Number : 1560018

🇨🇳

Shenyang, China

Investigational Site Number : 1560008

🇨🇳

Taiyuan, China

Investigational Site Number : 1560020

🇨🇳

Tianjin, China

Investigational Site Number : 1560011

🇨🇳

Wuhan, China

Investigational Site Number : 1560017

🇨🇳

Xi An, China

Investigational Site Number : 1910001

🇭🇷

Zagreb, Croatia

Investigational Site Number : 1910002

🇭🇷

Zagreb, Croatia

Investigational Site Number : 2039907

🇨🇿

Brno, Czechia

Investigational Site Number : 2030002

🇨🇿

Brno, Czechia

Investigational Site Number : 2039903

🇨🇿

Hradec Králové, Czechia

Investigational Site Number : 2039901

🇨🇿

Jihlava, Czechia

Investigational Site Number : 2039902

🇨🇿

Ostrava, Czechia

Investigational Site Number : 2039904

🇨🇿

Pardubice, Czechia

Investigational Site Number : 2030008

🇨🇿

Prague, Czechia

Investigational Site Number : 2039906

🇨🇿

Prague, Czechia

Investigational Site Number : 2039905

🇨🇿

Prague, Czechia

Investigational Site Number : 2030003

🇨🇿

Teplice, Czechia

Investigational Site Number : 2030007

🇨🇿

Zlín, Czechia

Investigational Site Number : 2080001

🇩🇰

Esbjerg, Denmark

Investigational Site Number : 2080005

🇩🇰

Holstebro, Denmark

Investigational Site Number : 2080004

🇩🇰

Odense, Denmark

Investigational Site Number : 2330001

🇪🇪

Tallinn, Estonia

Investigational Site Number : 2460001

🇫🇮

Tampere, Finland

Investigational Site Number : 2460002

🇫🇮

Turku, Finland

Investigational Site Number : 2500019

🇫🇷

Besançon, France

Investigational Site Number : 2500011

🇫🇷

Bron, France

Investigational Site Number : 2500005

🇫🇷

Clermont-ferrand, France

Investigational Site Number : 2500015

🇫🇷

Gonesse, France

Investigational Site Number : 2500009

🇫🇷

Lille, France

Investigational Site Number : 2500006

🇫🇷

Montpellier, France

Investigational Site Number : 2500008

🇫🇷

Nancy, France

Investigational Site Number : 2500002

🇫🇷

Nice, France

Investigational Site Number : 2500017

🇫🇷

Nîmes, France

Investigational Site Number : 2500007

🇫🇷

Paris, France

Investigational Site Number : 2500014

🇫🇷

Paris, France

Investigational Site Number : 2500004

🇫🇷

Poissy, France

Investigational Site Number : 2500003

🇫🇷

Rennes, France

Investigational Site Number : 2500010

🇫🇷

Saint-herblain, France

Investigational Site Number : 2500001

🇫🇷

Strasbourg, France

Investigational Site Number : 2500012

🇫🇷

Toulouse, France

Investigational Site Number : 2760005

🇩🇪

Bayreuth, Germany

Investigational Site Number : 2760009

🇩🇪

Berlin, Germany

Investigational Site Number : 2760015

🇩🇪

Berlin, Germany

Investigational Site Number : 2760014

🇩🇪

Berlin, Germany

Investigational Site Number : 2760020

🇩🇪

Bochum, Germany

Investigational Site Number : 2760001

🇩🇪

Dresden, Germany

Investigational Site Number : 2769901

🇩🇪

Düsseldorf, Germany

Investigational Site Number : 2760012

🇩🇪

Essen, Germany

Investigational Site Number : 2760002

🇩🇪

Giessen, Germany

Investigational Site Number : 2760016

🇩🇪

Hamburg, Germany

Investigational Site Number : 2760008

🇩🇪

Münster, Germany

Investigational Site Number : 2760011

🇩🇪

ULM, Germany

Investigational Site Number : 2760003

🇩🇪

Wã¼rzburg, Germany

Investigational Site Number : 3000006

🇬🇷

Athens, Greece

Investigational Site Number : 3000001

🇬🇷

Athens, Greece

Investigational Site Number : 3000002

🇬🇷

Athens, Greece

Investigational Site Number : 3000007

🇬🇷

Athens, Greece

Investigational Site Number : 3000004

🇬🇷

Larissa, Greece

Investigational Site Number : 3000003

🇬🇷

Thessaloniki, Greece

Investigational Site Number : 3440001

🇭🇰

Sha Tin, Hong Kong

Investigational Site Number : 3489901

🇭🇺

Budapest, Hungary

Investigational Site Number : 3480007

🇭🇺

Budapest, Hungary

Investigational Site Number : 3489903

🇭🇺

Budapest, Hungary

Investigational Site Number : 3480002

🇭🇺

Pã©cs, Hungary

Investigational Site Number : 3569904

🇮🇳

Chandigarh, India

Investigational Site Number : 3560007

🇮🇳

Gurugram, India

Investigational Site Number : 3569903

🇮🇳

Gurugram, India

Investigational Site Number : 3569901

🇮🇳

Mangaluru, India

Investigational Site Number : 3560009

🇮🇳

Nagpur, India

Investigational Site Number : 3569902

🇮🇳

New Delhi, India

Investigational Site Number : 3560002

🇮🇳

New Delhi, India

Investigational Site Number : 3560004

🇮🇳

Thiruvananthapuram, India

Investigational Site Number : 3760003

🇮🇱

Haifa, Israel

Investigational Site Number : 3760001

🇮🇱

Ramat Gan, Israel

Investigational Site Number : 3760006

🇮🇱

Rehovot, Israel

Investigational Site Number : 3760004

🇮🇱

Safed, Israel

Investigational Site Number : 3800016

🇮🇹

Florence, Firenze, Italy

Investigational Site Number : 3800010

🇮🇹

Milan, Lombardia, Italy

Investigational Site Number : 3800009

🇮🇹

Roma, Italy

Investigational Site Number : 3800013

🇮🇹

Rome, Roma, Italy

Investigational Site Number : 3800012

🇮🇹

Florence, Toscana, Italy

Investigational Site Number : 3800011

🇮🇹

Bergamo, Italy

Investigational Site Number : 3800007

🇮🇹

Cagliari, Italy

Investigational Site Number : 3800015

🇮🇹

Catania, Italy

Investigational Site Number : 3800014

🇮🇹

Genoa, Italy

Investigational Site Number : 3800001

🇮🇹

Milan, Italy

Investigational Site Number : 3800006

🇮🇹

Naples, Italy

Investigational Site Number : 3800008

🇮🇹

Pavia, Italy

Investigational Site Number : 3800002

🇮🇹

Pozzilli, Italy

Investigational Site Number : 3800005

🇮🇹

Rome, Italy

Investigational Site Number : 3920022

🇯🇵

Morioka, Iwate, Japan

Investigational Site Number : 3920023

🇯🇵

Sagamihara, Kanagawa, Japan

Investigational Site Number : 3920018

🇯🇵

Kawagoe, Saitama, Japan

Investigational Site Number : 3920011

🇯🇵

Kyoto, Japan

Investigational Site Number : 3920001

🇯🇵

Osaka, Japan

Investigational Site Number : 3920004

🇯🇵

Osaka, Japan

Investigational Site Number : 3920010

🇯🇵

Tokyo, Japan

Investigational Site Number : 4100001

🇰🇷

Goyang-si, Gyeonggi-do, Korea, Republic of

Investigational Site Number : 4100003

🇰🇷

Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number : 4100006

🇰🇷

Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number : 4100002

🇰🇷

Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number : 4280002

🇱🇻

Riga, Latvia

Investigational Site Number : 4280003

🇱🇻

Riga, Latvia

Investigational Site Number : 4400003

🇱🇹

Kaunas, Lithuania

Investigational Site Number : 4400004

🇱🇹

Siauliai, Lithuania

Investigational Site Number : 4400001

🇱🇹

Vilnius, Lithuania

Investigational Site Number : 4840002

🇲🇽

Mexico City, Ciudad De Mexico, Mexico

Investigational Site Number : 4840001

🇲🇽

Mexico City, Ciudad De Mexico, Mexico

Investigational Site Number : 4840003

🇲🇽

Veracruz, Mexico

Investigational Site Number : 5280001

🇳🇱

Amsterdam, Netherlands

Investigational Site Number : 5280002

🇳🇱

Heerlen, Netherlands

Investigational Site Number : 5780003

🇳🇴

Bergen, Norway

Investigational Site Number : 5780001

🇳🇴

Oslo, Norway

Investigational Site Number : 6160003

🇵🇱

Bydgoszcz, Kujawsko-pomorskie, Poland

Investigational Site Number : 6160001

🇵🇱

Lodz, Lódzkie, Poland

Investigational Site Number : 6160005

🇵🇱

Warsaw, Mazowieckie, Poland

Investigational Site Number : 6160006

🇵🇱

Warsaw, Mazowieckie, Poland

Investigational Site Number : 6160009

🇵🇱

Glogow, Podkarpackie, Poland

Investigational Site Number : 6160004

🇵🇱

Katowice, Slaskie, Poland

Investigational Site Number : 6160008

🇵🇱

Plewiska, Wielkopolskie, Poland

Investigational Site Number : 6160002

🇵🇱

Katowice, Poland

Investigational Site Number : 6160012

🇵🇱

Lublin, Poland

Investigational Site Number : 6160011

🇵🇱

Zabrze, Poland

Investigational Site Number : 6200001

🇵🇹

Braga, Portugal

Investigational Site Number : 6200005

🇵🇹

Coimbra, Portugal

Investigational Site Number : 6200011

🇵🇹

Lisbon, Portugal

Investigational Site Number : 6200006

🇵🇹

Lisbon, Portugal

Investigational Site Number : 6200004

🇵🇹

Santa Maria Da Feira, Portugal

San Juan MS Center- Site Number : 8400015

🇵🇷

Guaynabo, Puerto Rico

Investigational Site Number : 6420015

🇷🇴

Brașov, Romania

Investigational Site Number : 6420008

🇷🇴

Bucharest, Romania

Investigational Site Number : 6420006

🇷🇴

Cluj-napoca, Romania

Investigational Site Number : 6420003

🇷🇴

Constanta, Romania

Investigational Site Number : 6420004

🇷🇴

Câmpulung, Romania

Investigational Site Number : 6420013

🇷🇴

Oradea, Romania

Investigational Site Number : 6420005

🇷🇴

Sibiu, Romania

Investigational Site Number : 6420002

🇷🇴

Timișoara, Romania

Investigational Site Number : 6880001

🇷🇸

Belgrade, Serbia

Investigational Site Number : 6880003

🇷🇸

Belgrade, Serbia

Investigational Site Number : 6880006

🇷🇸

Belgrade, Serbia

Investigational Site Number : 6880002

🇷🇸

Kragujevac, Serbia

Investigational Site Number : 6880005

🇷🇸

Novi Sad, Serbia

Investigational Site Number : 7030001

🇸🇰

Bratislava, Slovakia

Investigational Site Number : 7030002

🇸🇰

Martin, Slovakia

Investigational Site Number : 7030004

🇸🇰

Nitra, Slovakia

Investigational Site Number : 7249908

🇪🇸

A Coruña, A Coruña [La Coruña], Spain

Investigational Site Number : 7249907

🇪🇸

Seville, Andalucia, Spain

Investigational Site Number : 7249906

🇪🇸

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7249912

🇪🇸

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7249919

🇪🇸

L'hospitalet de Llobregat, Barcelona [Barcelona], Spain

Investigational Site Number : 7249913

🇪🇸

Barakaldo, Bizkaia, Spain

Investigational Site Number : 7249918

🇪🇸

Donostia-san Sebastian, Gipuzkoa, Spain

Investigational Site Number : 7249911

🇪🇸

Girona, Girona [Gerona], Spain

Investigational Site Number : 7249904

🇪🇸

Las Palmas de Gran Canaria, Las Palmas, Spain

Investigational Site Number : 7249902

🇪🇸

Lleida, Lleida [Lérida], Spain

Investigational Site Number : 7249909

🇪🇸

Madrid, Madrid, Comunidad De, Spain

Investigational Site Number : 7249901

🇪🇸

Majadahonda, Madrid, Spain

Investigational Site Number : 7249905

🇪🇸

Pozuelo de Alarcón, Madrid, Spain

Investigational Site Number : 7249914

🇪🇸

Córdoba, Spain

Investigational Site Number : 7249903

🇪🇸

Madrid, Spain

Investigational Site Number : 7249910

🇪🇸

Madrid, Spain

Investigational Site Number : 7249916

🇪🇸

Murcia, Spain

Investigational Site Number : 7249915

🇪🇸

Málaga, Spain

Investigational Site Number : 7249917

🇪🇸

Valencia, Spain

Investigational Site Number : 7520001

🇸🇪

Gothenburg, Sweden

Investigational Site Number : 7520002

🇸🇪

Stockholm, Sweden

Investigational Site Number : 7560002

🇨🇭

Bern, Switzerland

Investigational Site Number : 1580007

🇨🇳

Hsinchu, Taiwan

Investigational Site Number : 1580002

🇨🇳

Taipei City, Taiwan

Investigational Site Number : 7929902

🇹🇷

Akdeniz, Turkey

Investigational Site Number : 7920006

🇹🇷

Ankara, Turkey

Investigational Site Number : 7920005

🇹🇷

Eskişehir, Turkey

Investigational Site Number : 7920002

🇹🇷

Istanbul, Turkey

Investigational Site Number : 7920009

🇹🇷

Istanbul, Turkey

Investigational Site Number : 7920007

🇹🇷

Istanbul, Turkey

Investigational Site Number : 7920003

🇹🇷

Istanbul, Turkey

Investigational Site Number : 7920010

🇹🇷

Izmir, Turkey

Investigational Site Number : 7920001

🇹🇷

Izmit, Turkey

Investigational Site Number : 7929901

🇹🇷

Kütahya, Turkey

Investigational Site Number : 7929903

🇹🇷

Samsun, Turkey

Investigational Site Number : 8040020

🇺🇦

Chernivtsi, Ukraine

Investigational Site Number : 8049912

🇺🇦

Chernivtsi, Ukraine

Investigational Site Number : 8049904

🇺🇦

Chernivtsi, Ukraine

Investigational Site Number : 8049905

🇺🇦

Dnipro, Ukraine

Investigational Site Number : 8040025

🇺🇦

Kharkiv, Ukraine

Investigational Site Number : 8049903

🇺🇦

Kharkiv, Ukraine

Investigational Site Number : 8040018

🇺🇦

Kharkiv, Ukraine

Investigational Site Number : 8049908

🇺🇦

Krykhivtsi, Ukraine

Investigational Site Number : 8049902

🇺🇦

Kyiv, Ukraine

Investigational Site Number : 8049911

🇺🇦

Kyiv, Ukraine

Investigational Site Number : 8049901

🇺🇦

Kyiv, Ukraine

Investigational Site Number : 8049914

🇺🇦

Lutsk, Ukraine

Investigational Site Number : 8049909

🇺🇦

Lviv, Ukraine

Investigational Site Number : 8049906

🇺🇦

Lviv, Ukraine

Investigational Site Number : 8049913

🇺🇦

Odesa, Ukraine

Investigational Site Number : 8040024

🇺🇦

Vinnytsia, Ukraine

Investigational Site Number : 8049910

🇺🇦

Vinnytsia, Ukraine

Investigational Site Number : 8260003

🇬🇧

Exeter, Devon, United Kingdom

Investigational Site Number : 8260016

🇬🇧

Canterbury, Kent, United Kingdom

Investigational Site Number : 8260005

🇬🇧

London, London, City Of, United Kingdom

Investigational Site Number : 8260019

🇬🇧

Salford, Manchester, United Kingdom

Investigational Site Number : 8260013

🇬🇧

Oxford, Oxfordshire, United Kingdom

Investigational Site Number : 8260009

🇬🇧

Bristol, United Kingdom

Investigational Site Number : 8260014

🇬🇧

Newcastle Upon Tyne, United Kingdom

Center for Neurology and Spine - Phoenix - North 32nd Street- Site Number : 8400089

🇺🇸

Phoenix, Arizona, United States

University of Colorado - Anschutz Medical Campus- Site Number : 8400012

🇺🇸

Aurora, Colorado, United States

Fort Wayne Neurological Center - North- Site Number : 8400039

🇺🇸

Fort Wayne, Indiana, United States

Harper University Hospital- Site Number : 8400046

🇺🇸

Detroit, Michigan, United States

University of New Mexico Comprehensive Cancer Center- Site Number : 8400032

🇺🇸

Albuquerque, New Mexico, United States

The Ohio State University- Site Number : 8400150

🇺🇸

Columbus, Ohio, United States

Investigational Site Number : 1240011

🇨🇦

Halifax, Nova Scotia, Canada

University of Alabama at Birmingham- Site Number : 8400013

🇺🇸

Birmingham, Alabama, United States

North Central Neurology Associates- Site Number : 8400009

🇺🇸

Cullman, Alabama, United States

University of California San Diego - La Jolla- Site Number : 8400101

🇺🇸

La Jolla, California, United States

Collaborative Neuroscience Research- Site Number : 8400045

🇺🇸

Los Alamitos, California, United States

Keck School of Medicine of University of Southern California- Site Number : 8400143

🇺🇸

Los Angeles, California, United States

Private Practice - Dr. Regina Berkovich- Site Number : 8400059

🇺🇸

West Hollywood, California, United States

Advanced Neurology of Colorado- Site Number : 8400025

🇺🇸

Fort Collins, Colorado, United States

MedStar Georgetown University Hospital- Site Number : 8400119

🇺🇸

Washington, District of Columbia, United States

SFM Clinical Research- Site Number : 8400029

🇺🇸

Boca Raton, Florida, United States

Neurology Associates - Maitland- Site Number : 8409902

🇺🇸

Maitland, Florida, United States

University of Miami- Site Number : 8400063

🇺🇸

Miami, Florida, United States

Aqualane Clinical Research- Site Number : 8400027

🇺🇸

Naples, Florida, United States

Axiom Clinical Research of Florida- Site Number : 8400001

🇺🇸

Tampa, Florida, United States

University of South Florida- Site Number : 8409905

🇺🇸

Tampa, Florida, United States

Velocity Clinical Research - Savannah Neurology- Site Number : 8409903

🇺🇸

Savannah, Georgia, United States

Consultants in Neurology- Site Number : 8409906

🇺🇸

Northbrook, Illinois, United States

Springfield Clinic 1st - 800 Building- Site Number : 8400071

🇺🇸

Springfield, Illinois, United States

University of Kansas Medical Center- Site Number : 8400023

🇺🇸

Kansas City, Kansas, United States

Norton Neurology Services- Site Number : 8400127

🇺🇸

Louisville, Kentucky, United States

The NeuroMedical Center- Site Number : 8400057

🇺🇸

Baton Rouge, Louisiana, United States

Michigan Institute for Neurological Disorders- Site Number : 8400058

🇺🇸

Farmington Hills, Michigan, United States

Memorial Healthcare Institute for Neuroscience- Site Number : 8400033

🇺🇸

Owosso, Michigan, United States

Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400051

🇺🇸

Golden Valley, Minnesota, United States

Sharlin Health & Neurology- Site Number : 8400093

🇺🇸

Ozark, Missouri, United States

Missouri Baptist Medical Center- Site Number : 8400019

🇺🇸

Saint Louis, Missouri, United States

Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400117

🇺🇸

Las Vegas, Nevada, United States

Icahn School of Medicine at Mount Sinai- Site Number : 8400038

🇺🇸

New York, New York, United States

South Shore Neurologic Associates - Patchogue- Site Number : 8400100

🇺🇸

Patchogue, New York, United States

Stony Brook University- Site Number : 8400042

🇺🇸

Stony Brook, New York, United States

Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400116

🇺🇸

Winston-Salem, North Carolina, United States

Dayton Center for Neurological Disorders- Site Number : 8400081

🇺🇸

Centerville, Ohio, United States

Cleveland Clinic - Cleveland- Site Number : 8400125

🇺🇸

Cleveland, Ohio, United States

The Boster Center for Multiple Sclerosis- Site Number : 8400147

🇺🇸

Columbus, Ohio, United States

Medical Center at Elizabeth Place- Site Number : 8409901

🇺🇸

Dayton, Ohio, United States

Providence St. Vincent's Medical Center- Site Number : 8400020

🇺🇸

Portland, Oregon, United States

Premier Neurology- Site Number : 8400069

🇺🇸

Greer, South Carolina, United States

Hope Neurology- Site Number : 8409904

🇺🇸

Knoxville, Tennessee, United States

Neurology Center of San Antonio- Site Number : 8400036

🇺🇸

San Antonio, Texas, United States

Texas Institute for Neurological Disorders - Sherman- Site Number : 8400151

🇺🇸

Sherman, Texas, United States

University of Vermont Medical Center- Site Number : 8400130

🇺🇸

Burlington, Vermont, United States

Neurological Associates - Richmond- Site Number : 8400097

🇺🇸

Richmond, Virginia, United States

Investigational Site Number : 0320007

🇦🇷

Buenos Aires, Ciudad De Buenos Aires, Argentina

Investigational Site Number : 0320001

🇦🇷

Buenos Aires, Ciudad De Buenos Aires, Argentina

Investigational Site Number : 0329901

🇦🇷

Caba, Ciudad De Buenos Aires, Argentina

Investigational Site Number : 0320003

🇦🇷

Rosario, Santa Fe, Argentina

Investigational Site Number : 0320002

🇦🇷

Buenos Aires, Argentina

Investigational Site Number : 0320004

🇦🇷

Buenos Aires, Argentina

Investigational Site Number : 0320006

🇦🇷

Córdoba, Argentina

Investigational Site Number : 0320005

🇦🇷

San Miguel de Tucumán, Argentina

© Copyright 2025. All Rights Reserved by MedPath