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Multiple SclerosisPhase 3SPI2NCT02936037

Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)

A Phase 3 study testing MD1003 100mg capsule in people with Multiple Sclerosis, run by MedDay Pharmaceuticals SA at 92 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
MD1003 100mg capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
642 participants
Where
92 sitesin 13 countries
Study dates
Dec 2016to 23 Apr 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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"

Who cannot join

  • 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 botulinum toxin (except for cosmetic purpose) initiated within 6 months prior to inclusion
  • In-patient rehabilitation program within the 3 months prior to inclusion
Show all 21Show fewer
  • 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

Trial locations and contacts

92 sites in 13 countries.

92 sites in 13 countries

United States40 sites

  • The University of New Mexico - Multiple Sclerosis Specialty Clinic

    Albuquerque, New Mexico, 87131

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • The Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287

  • Jordan Research And Education Institute Of Alta Bates Summit

    Berkeley, California, 94705

  • Harvard Medical School - Brigham and Women's Hospital - Center for Neurologic Diseases

    Boston, Massachusetts, 02115

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209

  • UBMD Neurology

    Buffalo, New York, 14203

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM)

    Chicago, Illinois, 60637

  • Cleveland Clinic Mellen Center for MS

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Wayne State University - Comp Clinic and MS Center

    Detroit, Michigan, 48201

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Minneapolis Clinic of Neurology, LTD

    Golden Valley, Minnesota, 55422

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Rowe Neurology Institute

    Lenexa, Kansas, 66214

  • University of Southern California Keck School of Medicine

    Los Angeles, California, 90033

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Vanderbilt Comprehensive Multiple Sclerosis Center

    Nashville, Tennessee, 37215

  • Ochsner Health System

    New Orleans, Louisiana, 70121

  • Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • MS Center of California

    Newport Beach, California, 92663

  • Yale New Haven Hospital

    North Haven, Connecticut, 06473

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurology Clinics (BNC)

    Phoenix, Arizona, 85013

  • Providence Multiple Sclerosis Center

    Portland, Oregon, 97225

  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina, 27607

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • UC Davis Health System

    Sacramento, California, 95817

  • UCSF Multiple Sclerosis Center

    San Francisco, California, 94158

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • State University of New York (SUNY)

    Stony Brook, New York, 11794

  • University of South Florida - Neurology

    Tampa, Florida, 33612

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

Other trials in United States

Germany10 sites

  • Caritas Krankenhaus

    Bad Mergentheim, 97980

  • Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center

    Berlin, 10117

  • Heinrich-Heine-Universität Düsseldorf

    Düsseldorf, 40225

  • Neuro Centrum Science GmbH

    Erbach im Odenwald, 64711

  • MultipEL Studies Institut für klinische Studien GbR

    Hamburg, 22179

  • Universitätsklinikum Leipzig A.ö.R. - Klinik und Poliklinik

    Leipzig, Saxony, 04103

  • Ludwig-Maximilians Universität München

    München, 81377

  • Neuropoint GmbH

    Ulm, 89073

  • Poliklinik für Neurologie Universitätsklinikum Ulm

    Ulm, 89081

  • Fachkrankenhaus Hubertusburg

    Wermsdorf, Saxony, 04779

Other trials in Germany

Canada8 sites

  • Burnaby Hospital

    Burnaby, British Columbia, V5G 2X6

  • Nova Scotia Rehabilitation Center

    Halifax, Nova Scotia, B3H 4K4

  • Hôpital universitaire Dr George L-Dumont university Hospital

    Moncton, New Brunswick, E1C 2Z3

  • Hopital de Notre Dame

    Montreal, Quebec, H2L 4M1

  • Montreal Neurologic Institute

    Montreal, Quebec, H3A 2B4

  • Ottawa Hospital General Campus

    Ottawa, Ontario, ON K1H 8L6

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Vancouver Hospital and Health Sciences Centre

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Spain7 sites

  • Hospital del Mar Servicio de Neurología

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Servicio de Neurología Hospital Vithas Nisa Aljarafe

    Castilleja de la Cuesta, Sevilla, 41950

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hostipal Universitario Quirónsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Santa Caterina

    Salt, Girona, 17190

Other trials in Spain

United Kingdom6 sites

  • The University of Edinburgh

    Edinburgh, EH16 4SB

  • Institute of Neurological Sciences

    Glasgow, G51 4TF

  • Barts And The London School Of Medicine And Dentistry Institute

    London, E1 2AT

  • University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery

    London, WC1N 3BG

  • Tyne Hospitals NHS Foundation

    Newcastle upon Tyne, NE1 4LP

  • Salford Royal Hospital

    Salford, M6 8HD

Other trials in United Kingdom

Czechia5 sites

  • doc. MUDr. Radomir Talab, CSc., neurologie

    Hradec Králové, 500 03

  • Nemocnice Jihlava

    Jihlava, 586 33

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 21

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Nemocnice Teplice

    Teplice, 415 29

Other trials in Czechia

Poland4 sites

  • Nasz Lekarz Ośrodek Badań Klinicznych

    Bydgoszcz, 85-794

  • COPERNICUS PL sp z o.o.,Szpital im. M.Kopernika Oddział Neurologiczny

    Gdansk, 80-803

  • Twoja Przychodnia Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01-868

Other trials in Poland

Australia3 sites

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Brain and Mind Centre/University of Sydney

    Sydney, New South Wales, 2050

Other trials in Australia

Belgium3 sites

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • UZ Gent

    Halle, Oost-Vlaanderen, 9000

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, Limburg, 3500

Other trials in Belgium

Italy2 sites

  • Ospedale San Raffaele, IRCCS

    Milan, 20132

  • AO S.Andrea, Università degli Studi di Roma La Sapienza

    Roma, 00189

Other trials in Italy

Sweden2 sites

  • Sahlgrenska Universitetssjukhus - MS Center forskningsenheten

    Gothenburg, 413 45

  • Karolinska University Hospital - Neurologmottagningen

    Stockholm, 171 76

Other trials in Sweden

Hungary1 site

  • Valeomed Kft

    Esztergom, 2500

Other trials in Hungary

Turkey (Türkiye)1 site

  • Ondokuz Mayis University Medical Faculty

    Samsun, 55139

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study

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.

Being tested
MD1003 100mg capsule, PLACEBO
Keywords
progressive multiple sclerosis, MS, EDSS, TW25, multiple sclerosis
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MD1003 100mg capsuleDrug

    Also called high dose biotin

  • PLACEBODrug

    an inactive substance

Study groups in NCT02936037
Study groupRoleWhat they receive
GROUP 1Placebo comparatorPlacebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
Receives: Drug: PLACEBO
GROUP 2ExperimentalMD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
Receives: Drug: MD1003 100mg capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Improved on Either Expanded Disability Status Scale (EDSS) or Time to Walk 25 Feet (TW25)

    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.

    Measured: 15 months

Secondary outcomes (3)

  1. Time to 12-Weeks Confirmed EDSS Progression

    12-weeks EDSS progression is defined by an increase of at least 1 point for baseline EDSS 3.5 to 5.5 and of at least 0.5 point for baseline EDSS 6 to 6.5 with respective confirmation 12 weeks later.

    Date of 12-weeks confirmed EDSS progression will be the first date of an EDSS progression (as defined above) that is confirmed 12 weeks later.

    Measured: 3 to 27 months

  2. CGI-I Score (Clinical Global Impression of Change - Improvement), Evaluated Both by the Patient (SGI) and by the Evaluating Physician (CGI)

    Measured: 15 months

  3. Mean Change in TW25 Between M0 and M15

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion15 Nov 2019
  4. Study completion23 Apr 2020

Why it stopped: Sponsor decision for business purposes

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
PART 1: 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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02936037
Sponsor's protocol ID
MD1003CT2016-01MS-SPI2
Acronym
SPI2
Status last verified
Oct 2020
First submitted
14 Oct 2016
Last updated
23 Nov 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Joseph GB, McCune M, Bove R, Abdelhak A, Cree BAC, Block VJ. Association Between Neurofilament Light Chain and Real-World Ambulatory Function in Progressive MS. Ann Clin Transl Neurol. 2026 Sep 9. doi: 10.1002/acn3.70527. Online ahead of print.

    PubMed 42712237

  • 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.

    PubMed 33222767

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MD1003 100mg capsule in people with Multiple Sclerosis, run by MedDay Pharmaceuticals SA at 92 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Germany, Canada, Spain, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Improved on Either Expanded Disability Status Scale (EDSS) or Time to Walk 25 Feet (TW25) (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02936037, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.

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SPI2 Clinical Trial NCT02936037 | AzTrials