Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) (SPI2)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02936037 |
|
Recruitment Status
:
Recruiting
First Posted
: October 18, 2016
Last Update Posted
: April 4, 2018
|
Sponsor:
MedDay Pharmaceuticals SA
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis | Drug: MD1003 100mg capsule Drug: PLACEBO | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized double blind placebo-controlled for at least 15 months, followed by an open label extension phase of up to 12 months. The placebo-controlled phase, will end when the last patient randomized will perform his 15 months evaluation (visit 7). Then all patients will be treated with the active drug during an open-label extension phase for a total study duration of 27 months. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study |
| Actual Study Start Date : | December 2016 |
| Estimated Primary Completion Date : | September 2018 |
| Estimated Study Completion Date : | September 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: GROUP 1
Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months at least, then switch to MD1003 100mg capsule, 1 capsule tid for up to 12 months
|
Drug: MD1003 100mg capsule
Other Name: high dose biotin
Drug: PLACEBO
an inactive substance
|
|
Experimental: GROUP 2
MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months at least (double blind period) and then for all patients in open label extension for up to 12 months
|
Drug: MD1003 100mg capsule
Other Name: high dose biotin
|
Primary Outcome Measures
:
- Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) [ Time Frame: 15 months ]
Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) :
- with decreased EDSS at M12 confirmed at M15 (where decreased EDSS is defined as a decrease of at least 1 point if initial EDSS from 3.5 to 5.5 and of at least 0.5 point if initial EDSS from 6 to 6.5)
or
- with improved TW25 of at least 20% at Month 12 and Month15
compared to the lowest of the two EDSS and TW25* scores among inclusion and randomization visits.
*The lowest TW25 value recorded among the four values obtained during the inclusion and randomization visits will be considered as the baseline TW25 value.
Secondary Outcome Measures
:
- Time to EDSS progression confirmed at 12 weeks [ Time Frame: 15 months ]
- CGI-I score (clinical global impression of change - improvement), evaluated both by the patient (SGI) and by the evaluating physician (CGI) [ Time Frame: 15 months ]
- Mean change in TW25 between M0 and M15 [ Time Frame: 15 months ]
Other Outcome Measures:
- Brain MRI changes between M0 and M15 [ Time Frame: 15 months ]
- Remote monitoring of ambulation [ Time Frame: 15 months ]
- (MSQOL54) & (CAREQOL-MS) subscores and composite scores [ Time Frame: 15 months ]
- Subscores of the Kurtzke functional score [ Time Frame: 15 months ]
- Symbol digit modalities test (SDMT) [ Time Frame: 15 months ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient aged 18-65 years old
- Signed and dated written informed consent form in accordance with local regulations: having freely given their written informed consent to participate in the study
- Diagnosis of primary or secondary progressive MS fulfilling revised McDonald criteria (2010) and Lublin criteria (2014)
- Documented evidence of clinical disability progression within the 2 years prior to inclusion, i.e. a) progression of EDSS during the past two years of at least 1 point sustained for at least 6 months if inclusion EDSS is from 3.5 to 5.5 or at least 0.5 point increase sustained for at least 6 months if inclusion EDSS is from 6 to 6.5 or b) increase of TW25 by at least 20% in the last two years sustained for at least 6 months or c) other well-documented objective worsening validated by the Adjudication Committee
- EDSS at inclusion from 3.5 to 6.5
- TW25 < 40 seconds
- Kurtzke pyramidal functional subscore ≥2 defined as "minimal disability: patient complains of motor-fatigability or reduced performance in strenuous motor tasks (motor performance grade 1) and/or BMRC grade 4 in one or two muscle groups"
Exclusion Criteria:
- Clinical evidence of a relapse in 24 months prior to inclusion
- Treatment with any product containing biotin as single ingredient within six months prior to inclusion (multivitamin supplementation authorized if biotin < 1mg per day)
- Concomitant treatment with fampridine at inclusion or in the 30 days prior to inclusion
- New immunosuppressive/immunomodulatory drug initiated less than 90 days prior to inclusion
- Treatment with botulinium toxin (except for cosmetic purpose) initiated within 6 months prior to inclusion
- In-patient rehabilitation program within the 3 months prior to inclusion
- Pregnancy, breastfeeding or women with childbearing potential without acceptable form of contraception
- Men unwilling to use an acceptable form of contraception
- Any general chronic handicapping/incapacitating disease other than MS
- Any serious disease necessitating biological follow-up with biological tests using biotinylated antibodies or substrates
- Past history of rhabdomyolysis/metabolic myopathy
- Known fatty acids beta oxidation defect
- Known hypersensitivity or intolerance to biotin, analogues or excipients, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patients with hypersensitivity or any contra-indication to Gadolinium
- Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer
- Laboratory tests out of normal ranges considered by the investigator as clinically significant with regards to the study continuation
- Patients with history or presence of alcohol abuse or drug addiction
- Untreated or uncontrolled psychiatric disorders, especially suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
- Participation in another research study involving an investigational product (IP) in the 90 days prior to inclusion, or planned use during the study duration
- Patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve
- Relapse that occurs between inclusion and randomization visit
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936037
Contacts
| Contact: abdelkarim Bendarraz | clinical.trials@medday-pharma.com |
Hide Study Locations
Locations
| United States, Arizona | |
| Barrow Neurology Clinics | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Principal Investigator: Aimee Borazanci, MD | |
| Mayo Clinic Arizona | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Principal Investigator: Jonathan Carter, MD | |
| United States, California | |
| Sutter East Bay Medical Foundation | Recruiting |
| Berkeley, California, United States, 94705 | |
| Principal Investigator: Joanna Cooper, MD | |
| Neuro-Pain Medical Center | Recruiting |
| Fresno, California, United States, 93710 | |
| Principal Investigator: Perminder Bhatia, MD | |
| University of Southern California Keck School of Medicine | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: Lilyana Amezcua, MD | |
| MS Center of California | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Principal Investigator: Daniel S Bandari, MD | |
| UC Davis Health System | Recruiting |
| Sacramento, California, United States, 95817-2307 | |
| Principal Investigator: Michelle Apperson, MD | |
| UCSF Multiple Sclerosis Center | Recruiting |
| San Francisco, California, United States, 94117 | |
| Principal Investigator: Bruce Cree, MD | |
| United States, Colorado | |
| University of Colorado Denver | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Principal Investigator: John Corboy, MD | |
| United States, Connecticut | |
| Yale New Haven Hospital | Recruiting |
| North Haven, Connecticut, United States, 06473 | |
| Principal Investigator: Sharon Stoll, MD | |
| United States, Florida | |
| Nova Clinical Research, LLC | Recruiting |
| Bradenton, Florida, United States, 34209 | |
| Principal Investigator: Sanjay Yathiraj, MD | |
| University of Miami Miller School of Medicine | Recruiting |
| Miami, Florida, United States, 33136 | |
| Principal Investigator: Kottil Rammohan, MD | |
| University South Florida Medical Clinic | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: Derrick Robertson, MD | |
| United States, Illinois | |
| Northwestern University - Feinberg School of Medicine | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Bruce Cohen, MD | |
| University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM) | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: Anthony Reder, MD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: Sharon Lynch, MD | |
| Rowe Neurology Institute | Recruiting |
| Lenexa, Kansas, United States, 66214 | |
| Principal Investigator: Vernon Rowe, MD | |
| United States, Louisiana | |
| Ochner Health System | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Principal Investigator: Bridget Bagert, MD | |
| United States, Maryland | |
| Johns Hopkins Medicine Neurology & Neurosurgery | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: Shiv Saidha, MD | |
| United States, Massachusetts | |
| Harvard Medical School - Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115-5727 | |
| Principal Investigator: Christopher Severson, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Principal Investigator: Evanthia Bernitsas, MD | |
| United States, Minnesota | |
| Minneapolis Clinic of Neurology | Recruiting |
| Minneapolis, Minnesota, United States, 55422 | |
| Principal Investigator: Jonathan Calkwood, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: Robert Naismith, MD | |
| United States, New Jersey | |
| Holy Name Hospital | Recruiting |
| Teaneck, New Jersey, United States, 07666 | |
| Principal Investigator: Mary Ann Picone, MD | |
| United States, New Mexico | |
| The University of New Mexico - Multiple Sclerosis Specialty Clinic | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Principal Investigator: Corey Ford, MD | |
| United States, New York | |
| SUNY Buffalo - University Neurology, Inc | Recruiting |
| Buffalo, New York, United States, 14203 | |
| Principal Investigator: Bianca Weinstock-Guttman, MD | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10021-0005 | |
| Principal Investigator: Claire Riley, MD | |
| Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS | Recruiting |
| New York, New York, United States, 10029-6574 | |
| Principal Investigator: Aaron E Miller, MD | |
| Sub-Investigator: Fred D Lublin, MD | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Sub-Investigator: Andrew Goodman, MD | |
| Principal Investigator: Lawrence Samkoff, MD | |
| State University of New York (SUNY) | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Principal Investigator: Patricia Coyle, MD | |
| United States, North Carolina | |
| Raleigh Neurology Associates, P.A. | Recruiting |
| Raleigh, North Carolina, United States, 27607 | |
| Principal Investigator: Mitchell Freedman, MD | |
| United States, Ohio | |
| Cleveland Clinic Mellen Center for MS | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: Devon Conway | |
| United States, Oregon | |
| Providence Multiple Sclerosis Center | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Principal Investigator: Kyle Smoot, MD | |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: Thomas Leist, MD | |
| United States, Tennessee | |
| Cole Neuroscience Center | Recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| Principal Investigator: Randy Trudell, MD | |
| Vanderbilt Comprehensive Multiple Sclerosis Center | Recruiting |
| Nashville, Tennessee, United States, 37215 | |
| Principal Investigator: Harold Moses, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390-8829 | |
| Principal Investigator: Benjamin Greenberg, MD | |
| Central Texas Neurology Consultants | Recruiting |
| Round Rock, Texas, United States, 78681 | |
| Principal Investigator: Fox Edward, MD | |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Principal Investigator: Myla Goldman, MD | |
| United States, Washington | |
| Virginia Mason Medical Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Principal Investigator: Kita Mariko, MD | |
| Australia, New South Wales | |
| John Hunter Hospital | Not yet recruiting |
| New Lambton, New South Wales, Australia, 2310 | |
| Principal Investigator: Jeannette Lechner-Scott | |
| Australia, Queensland | |
| Griffith University School of Medicine | Not yet recruiting |
| Southport, Queensland, Australia, 4215 | |
| Principal Investigator: Simon Broadley | |
| Australia, South Australia | |
| Flinders Medical Centre | Not yet recruiting |
| Adelaide, South Australia, Australia, 5001 | |
| Principal Investigator: Mark Slee | |
| Australia, Victoria | |
| Austin Hospital | Not yet recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Principal Investigator: Richard Macdonell | |
| The Royal Melbourne Hospital | Not yet recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Principal Investigator: Mark Marriott | |
| Australia | |
| Eastern Health Multiple Sclerosis Service - Eastern Clinical Research Unit | Not yet recruiting |
| Box Hill, Australia, 3128 | |
| Principal Investigator: Katherine Buzzard | |
| St Vincent's Hospital | Not yet recruiting |
| Fitzroy, Australia | |
| Principal Investigator: Neil SHUEY | |
| Brain and Mind Centre/University of Sydney | Not yet recruiting |
| Sydney, Australia, 2050 | |
| Principal Investigator: Joshua BARTON | |
| Belgium | |
| Jessa Ziekenhuis - Campus Virga Jesse | Not yet recruiting |
| Hasselt, Limburg, Belgium, 3500 | |
| Principal Investigator: Nina De Klippel | |
| UZ Gent | Not yet recruiting |
| Halle, Oost-Vlaanderen, Belgium | |
| Principal Investigator: Guy Laureys | |
| Universite Libre de Bruxelles - Hopital Erasme | Not yet recruiting |
| Anderlecht, Belgium, 1070 | |
| Principal Investigator: Gaetano Perrotta | |
| UZ Antwerpen | Not yet recruiting |
| Edegem, Belgium, 2650 | |
| Principal Investigator: Barbara Willekens | |
| Revalidatie & Ms Centrum | Not yet recruiting |
| Overpelt, Belgium, 3900 | |
| Principal Investigator: Bart Van Wijmeersch | |
| Canada, British Columbia | |
| Burnaby Hospital | Recruiting |
| Burnaby, British Columbia, Canada, V5G 1T4 | |
| Principal Investigator: Galina Vorobeychik, MD | |
| Vancouver Hospital and Health Sciences Centre | Recruiting |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Principal Investigator: Virginia Devonshire, MD | |
| Canada, New Brunswick | |
| Hôpital universitaire Dr George L-Dumont university Hospital | Recruiting |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Principal Investigator: Ludivine Witkowski, MD | |
| Canada, Nova Scotia | |
| Nova Scotia Rehabilitation Center | Not yet recruiting |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Principal Investigator: Roger McKelvey, MD | |
| Canada, Ontario | |
| Ottawa Hospital General Campus | Recruiting |
| Ottawa, Ontario, Canada, ON K1H 8L6 | |
| Principal Investigator: Mark Freedman, MD | |
| Trillium Health Centre | Recruiting |
| Toronto, Ontario, Canada, L5B 1B8 | |
| Principal Investigator: Daniel Selchen, MD | |
| Canada, Quebec | |
| Montreal Neurologic Institute | Recruiting |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Principal Investigator: Paul Giacomini, MD | |
| Canada | |
| Hopital de Notre Dame | Recruiting |
| Montréal, Canada, H2L 4M1 | |
| Principal Investigator: J.Marc Girard, MD | |
| Czechia | |
| Doc. Radomir Talab - neurologist | Recruiting |
| Hradec Králové, Czechia, 500 03 | |
| Principal Investigator: Radomir Talab, MD | |
| Nemocnice Jihlava | Recruiting |
| Jihlava, Czechia, 586 33 | |
| Principal Investigator: Radek Ampapa, MD | |
| Vseobecna fakultni nemocnice v Praze | Recruiting |
| Praha, Czechia, 128 21 | |
| Principal Investigator: Jana Lizrova Preiningerova, MD | |
| Fakultni nemocnice v Motole | Recruiting |
| Praha, Czechia, 150 06 | |
| Principal Investigator: Eva Meluzinova, MD | |
| Nemocnice Teplice | Recruiting |
| Teplice, Czechia, 415 29 | |
| Principal Investigator: Marta Vachova, MD | |
| Germany | |
| Universitätsklinikum Essen | Not yet recruiting |
| Essen, Nordrhein-Westfalen, Germany, 45147 | |
| Principal Investigator: Refik Pul | |
| Universitätsklinikum Carl Gustav Carus an der TU Dresden | Not yet recruiting |
| Dresden, Sachsen, Germany, 01307 | |
| Principal Investigator: Tjalf Ziemssen | |
| Universitätsklinikum Leipzig A.ö.R. | Not yet recruiting |
| Leipzig, Sachsen, Germany, 04103 | |
| Principal Investigator: Wolfgang Köhler | |
| MS Ambulanz | Recruiting |
| Wermsdorf, Sachsen, Germany, 4779 | |
| Principal Investigator: Piotr Sokolowski, MD | |
| Caritas Krankenhaus | Recruiting |
| Bad Mergentheim, Germany, 97980 | |
| Principal Investigator: Mathias Buttmann, MD | |
| Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center | Recruiting |
| Berlin, Germany, 10117 | |
| Principal Investigator: Friedemann Paul, MD | |
| Universitätsklinikum Düsseldorf | Recruiting |
| Dusseldorf, Germany, 40225 | |
| Principal Investigator: Aktas Orhan, MD | |
| Multiple Studies Institut für klinische Studien GbR | Recruiting |
| Hamburg, Germany, 22179 | |
| Principal Investigator: Birte Elias-Hamp | |
| Neuro Centrum Science GmbH | Recruiting |
| Hessen, Germany, 64711 | |
| Principal Investigator: Gerd Reifschneider, MD | |
| Ludwig-Maximilians Universität München | Recruiting |
| München, Germany, 81377 | |
| Principal Investigator: Tania Kümpfel, MD | |
| Neuropoint GmbH | Recruiting |
| Ulm, Germany, 89073 | |
| Principal Investigator: Daniela Rau, MD | |
| Poliklinik für Neurologie Oberer Eselsberg 45 | Recruiting |
| Ulm, Germany, 89081 | |
| Principal Investigator: Tumani Hayrettin, MD | |
| Hungary | |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo | Not yet recruiting |
| Szeged, Csongrád, Hungary, 6725 | |
| Principal Investigator: Lászlo Vécsei | |
| Uzsoki Utcai Korhaz | Not yet recruiting |
| Budapest, Hungary, H-1145 | |
| Principal Investigator: Gabor Jakab | |
| MH Egeszsegugyi Kozpont | Not yet recruiting |
| Budapest, Hungary | |
| Principal Investigator: Zoltán Szakacs, MD | |
| Valeomed Kft | Not yet recruiting |
| Esztergom, Hungary | |
| Principal Investigator: Maria Satori, MD | |
| Pecsi Tudomanyegyetem Klinikai Kp | Not yet recruiting |
| Pécs, Hungary | |
| Principal Investigator: Sámuel Komoly, MD | |
| Italy | |
| Ospedale San Raffaele, IRCCS | Recruiting |
| Milano, Italy, 20127 | |
| Principal Investigator: Giancarlo Comi, MD | |
| AO S.Andrea, Università degli Studi di Roma La Sapienza | Recruiting |
| Roma, Italy, 00189 | |
| Principal Investigator: Carlo Pozzilli, MD | |
| Netherlands | |
| Stichting Zuyderland Medisch Centrum | Not yet recruiting |
| Sittard, Limburg, Netherlands, 6162 BG | |
| Principal Investigator: Raymond Hupperts | |
| Alrijne Ziekenhuis Leiden | Not yet recruiting |
| Leiden, Netherlands, 2300 RD | |
| Principal Investigator: Elske Hoitsma | |
| St. Antonius Ziekenhuis | Not yet recruiting |
| Nieuwegein, Netherlands, 3435 CM | |
| Principal Investigator: Frequin | |
| Poland | |
| SP Zaklad Opieki Zdrowotnej w Dzialdowie | Not yet recruiting |
| Dzialdowo, Warminsko-mazurskie, Poland, 13-200 | |
| Principal Investigator: Marek Zalisz | |
| Nasz Lekarz Ośrodek Badań Klinicznych | Not yet recruiting |
| Bydgoszcz, Poland, 85-794 | |
| Principal Investigator: Jozef Koscielniak, MD | |
| COPERNICUS PL sp z o.o.,Szpital im. M.Kopernika Oddział Neurologiczny | Not yet recruiting |
| Gdansk, Poland, 80-803 | |
| Principal Investigator: Waldemar Fryze, MD | |
| Krakowska Akademia Neurologii | Not yet recruiting |
| Krakow, Poland, 31-505 | |
| Principal Investigator: Andrzej Szczudlik, Pr. | |
| Twoja Przychodnia Centrum Medyczne Nowa Sol | Not yet recruiting |
| Nowa Sol, Poland, 71-270 | |
| Principal Investigator: Agata Klosek, MD | |
| Miedzyleski Szpital Specjalistyczny w Warszawie | Not yet recruiting |
| Warsawa, Poland | |
| Principal Investigator: Jacek Zaborski, MD | |
| Pratia S.A. | Not yet recruiting |
| Warszawa, Poland, 01-868 | |
| Principal Investigator: Malgorzata Zajda, MD | |
| Spain | |
| Hospital Santa Caterina | Recruiting |
| Girona, Gerona, Spain, 17190 | |
| Principal Investigator: Lluís Ramió i Torrentá, MD | |
| Hostipal Universitario Quirónsalud Madrid | Recruiting |
| Pozuelo de Alarcón, Madrid, Spain, 28223 | |
| Principal Investigator: Rafael Arroyo, MD | |
| Servicio de Neurología Hospital Vithas Nisa | Not yet recruiting |
| Castilleja de la Cuesta, Sevilla, Spain, 41950 | |
| Principal Investigator: Guillermo Izquierdo Ayuso | |
| Hospital del Mar Servicio de Neurología | Recruiting |
| Barcelona, Spain, 08003 | |
| Principal Investigator: Jose Martínez Rodríguez, MD | |
| Hospital Universitari Vall d'Hebron | Recruiting |
| Barcelona, Spain, 08035 | |
| Principal Investigator: Xavier Montalbán, MD | |
| Hospital Clínico San Carlos | Not yet recruiting |
| Madrid, Spain, 28040 | |
| Principal Investigator: Celia Oreja Guevara | |
| Hospital General de Málaga | Recruiting |
| Malaga, Spain, 29010 | |
| Principal Investigator: Victoria Fernández Sánchez, MD | |
| Sweden | |
| Sahlgrenska Universitetssjukhus | Recruiting |
| Göteborg, Sweden, 416 85 | |
| Principal Investigator: Jan Lycke, MD | |
| Karolinska Institutet | Recruiting |
| Stockholm, Sweden, SE-171 77 | |
| Principal Investigator: Lou Brundin, MD | |
| Turkey | |
| Hacettepe University Medical Faculty | Not yet recruiting |
| Ankara, Turkey, 06230 | |
| Principal Investigator: Rana Karabudak | |
| Haseki Training and Research Hospital | Not yet recruiting |
| Istanbul, Turkey | |
| Principal Investigator: Belgin Petek Balci | |
| Medeniyet University Goztepe Training and Research Hospital | Not yet recruiting |
| Istanbul, Turkey | |
| Principal Investigator: Ilknur Aydin Canturk | |
| Ondokuz Mayis University Medical Faculty | Not yet recruiting |
| Samsun, Turkey, 55139 | |
| Principal Investigator: Murat Terzi | |
| Karadeniz Technical university Medical Faculty | Not yet recruiting |
| Trabzon, Turkey, 61081 | |
| Principal Investigator: Cavit Boz | |
| United Kingdom | |
| The University of Edinburgh | Recruiting |
| Edinburgh, United Kingdom, EH16 4SB | |
| Principal Investigator: Don Mahad, MD | |
| Institute of Neurological Sciences | Recruiting |
| Glasgow, United Kingdom, G51 4TF | |
| Principal Investigator: Webb Stewart, MD | |
| Barts And The London School Of Medicine And Dentistry Institute | Recruiting |
| London, United Kingdom, E1 2AT | |
| Principal Investigator: Schmierer Klaus, MD | |
| University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery | Recruiting |
| London, United Kingdom, WC1N 3BG | |
| Principal Investigator: Ahmed Toosy, MD | |
| Tyne Hospitals NHS Foundation | Recruiting |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
| Principal Investigator: Joe Guadagno, MD | |
| Salford Royal Hospital | Recruiting |
| Salford, United Kingdom, M6 8HD | |
| Principal Investigator: Adrian Pace, MD | |
| Royal Hallamshire Hospital | Not yet recruiting |
| Sheffield, United Kingdom, S10 2JF | |
| Principal Investigator: David Paling | |
Sponsors and Collaborators
MedDay Pharmaceuticals SA
Investigators
| Principal Investigator: | Bruce Cree, MD, PHD | University of California, San Francisco | |
| Study Director: | Frederic Sedel, MD, PHD | Medday Pharmaceuticals |
Additional Information:
| Responsible Party: | MedDay Pharmaceuticals SA |
| ClinicalTrials.gov Identifier: | NCT02936037 History of Changes |
| Other Study ID Numbers: |
MD1003CT2016-01MS-SPI2 |
| First Posted: | October 18, 2016 Key Record Dates |
| Last Update Posted: | April 4, 2018 |
| Last Verified: | March 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by MedDay Pharmaceuticals SA:
|
progressive multiple sclerosis MS EDSS TW25 multiple sclerosis |
Additional relevant MeSH terms:
|
Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |