Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)
NCT ID: NCT02936037
Last Updated: 2020-11-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
642 participants
INTERVENTIONAL
2016-12-31
2020-04-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Total duration of Part 1 is 27 months. The randomized double-blind placebo-controlled period ranges from 15 to 27 months depending upon the randomization date of an individual patient.
Once the last month 15 evaluation of the study has been completed, patients will switch to the active drug at the next planned visit. Participants and study personnel will remain blinded as to the original treatment assignment.
Maximum duration of double-blind period per patient will be no longer than 27 months.
PART 2:
At the last evaluation of Part 1 (Visit 11/Month 27) all participants will be offered active treatment in an open label extension for 39 additional months (From V11/M27 to V18/M66).
The purpose of the active drug extension is to further define the safety of MD1003.
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GROUP 1
Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
PLACEBO
an inactive substance
GROUP 2
MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
MD1003 100mg capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MD1003 100mg capsule
PLACEBO
an inactive substance
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 at inclusion visit
* 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
* 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 botulinum 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedDay Pharmaceuticals SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruce Cree, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Frederic Sedel, MD, PHD
Role: STUDY_DIRECTOR
Medday Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barrow Neurology Clinics (BNC)
Phoenix, Arizona, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Jordan Research And Education Institute Of Alta Bates Summit
Berkeley, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
University of Southern California Keck School of Medicine
Los Angeles, California, United States
MS Center of California
Newport Beach, California, United States
UC Davis Health System
Sacramento, California, United States
UCSF Multiple Sclerosis Center
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale New Haven Hospital
North Haven, Connecticut, United States
Nova Clinical Research, LLC
Bradenton, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
University of South Florida - Neurology
Tampa, Florida, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM)
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Rowe Neurology Institute
Lenexa, Kansas, United States
Ochsner Health System
New Orleans, Louisiana, United States
The Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
Harvard Medical School - Brigham and Women's Hospital - Center for Neurologic Diseases
Boston, Massachusetts, United States
Wayne State University - Comp Clinic and MS Center
Detroit, Michigan, United States
Minneapolis Clinic of Neurology, LTD
Golden Valley, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Holy Name Hospital
Teaneck, New Jersey, United States
The University of New Mexico - Multiple Sclerosis Specialty Clinic
Albuquerque, New Mexico, United States
UBMD Neurology
Buffalo, New York, United States
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
State University of New York (SUNY)
Stony Brook, New York, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States
Cleveland Clinic Mellen Center for MS
Cleveland, Ohio, United States
Providence Multiple Sclerosis Center
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Vanderbilt Comprehensive Multiple Sclerosis Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Brain and Mind Centre/University of Sydney
Sydney, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
UZ Antwerpen
Edegem, Antwerpen, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Limburg, Belgium
UZ Gent
Halle, Oost-Vlaanderen, Belgium
Burnaby Hospital
Burnaby, British Columbia, Canada
Vancouver Hospital and Health Sciences Centre
Vancouver, British Columbia, Canada
Hôpital universitaire Dr George L-Dumont university Hospital
Moncton, New Brunswick, Canada
Nova Scotia Rehabilitation Center
Halifax, Nova Scotia, Canada
Ottawa Hospital General Campus
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Hopital de Notre Dame
Montreal, Quebec, Canada
Montreal Neurologic Institute
Montreal, Quebec, Canada
doc. MUDr. Radomir Talab, CSc., neurologie
Hradec Králové, , Czechia
Nemocnice Jihlava
Jihlava, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Nemocnice Teplice
Teplice, , Czechia
Universitätsklinikum Leipzig A.ö.R. - Klinik und Poliklinik
Leipzig, Saxony, Germany
Fachkrankenhaus Hubertusburg
Wermsdorf, Saxony, Germany
Caritas Krankenhaus
Bad Mergentheim, , Germany
Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center
Berlin, , Germany
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, , Germany
Neuro Centrum Science GmbH
Erbach im Odenwald, , Germany
MultipEL Studies Institut für klinische Studien GbR
Hamburg, , Germany
Ludwig-Maximilians Universität München
München, , Germany
Neuropoint GmbH
Ulm, , Germany
Poliklinik für Neurologie Universitätsklinikum Ulm
Ulm, , Germany
Valeomed Kft
Esztergom, , Hungary
Ospedale San Raffaele, IRCCS
Milan, , Italy
AO S.Andrea, Università degli Studi di Roma La Sapienza
Roma, , Italy
Nasz Lekarz Ośrodek Badań Klinicznych
Bydgoszcz, , Poland
COPERNICUS PL sp z o.o.,Szpital im. M.Kopernika Oddział Neurologiczny
Gdansk, , Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
Centrum Medyczne Pratia Warszawa
Warsaw, , Poland
Hospital Santa Caterina
Salt, Girona, Spain
Hostipal Universitario Quirónsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Servicio de Neurología Hospital Vithas Nisa Aljarafe
Castilleja de la Cuesta, Sevilla, Spain
Hospital del Mar Servicio de Neurología
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Sahlgrenska Universitetssjukhus - MS Center forskningsenheten
Gothenburg, , Sweden
Karolinska University Hospital - Neurologmottagningen
Stockholm, , Sweden
Ondokuz Mayis University Medical Faculty
Samsun, , Turkey (Türkiye)
The University of Edinburgh
Edinburgh, , United Kingdom
Institute of Neurological Sciences
Glasgow, , United Kingdom
Barts And The London School Of Medicine And Dentistry Institute
London, , United Kingdom
University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery
London, , United Kingdom
Tyne Hospitals NHS Foundation
Newcastle upon Tyne, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cree BAC, Cutter G, Wolinsky JS, Freedman MS, Comi G, Giovannoni G, Hartung HP, Arnold D, Kuhle J, Block V, Munschauer FE, Sedel F, Lublin FD; SPI2 investigative teams. Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2020 Dec;19(12):988-997. doi: 10.1016/S1474-4422(20)30347-1. Epub 2020 Oct 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MD1003CT2016-01MS-SPI2
Identifier Type: -
Identifier Source: org_study_id