A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
- Conditions
- Relapsing Multiple SclerosisSecondary Progressive Multiple SclerosisProgressive Relapsing Multiple Sclerosis
- Interventions
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tolebrutinib Tolebrutinib * 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. Tolebrutinib Placebo * 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. Teriflunomide Placebo * 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. Teriflunomide Teriflunomide * 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
Name Time Method 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 discontinuation From 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
Name Time Method 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 studies From 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 \>5.0Annualized Relapse Rate (ARR) for RMS only From 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 year From baseline until the End of study approximately 3 years per participant Change from baseline in total volume of T2-hyperintense lesions From baseline until the End of study approximately 3 years per participant ToleDYNAMIC substudy Change from baseline in biomarkers From 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