Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) (SPI2)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02936037 |
Recruitment Status :
Terminated
(Sponsor decision for business purposes)
First Posted : October 18, 2016
Results First Posted : November 23, 2020
Last Update Posted : November 23, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: MD1003 100mg capsule Drug: PLACEBO | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 642 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (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 |
Actual Primary Completion Date : | November 15, 2019 |
Actual Study Completion Date : | April 23, 2020 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: GROUP 1
Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
|
Drug: PLACEBO
an inactive substance |
Experimental: GROUP 2
MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
|
Drug: MD1003 100mg capsule
Other Name: high dose biotin |
- 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.
- Time to 12-Weeks Confirmed EDSS Progression [ Time Frame: 3 to 27 months ]
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.
- 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 ]
- Brain MRI Changes Between M0 and M15 [ Time Frame: 15 months ]
- Remote Monitoring of Ambulation [ Time Frame: 27 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 ]

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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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:
- 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
- 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

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

United States, Arizona | |
Barrow Neurology Clinics (BNC) | |
Phoenix, Arizona, United States, 85013 | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
Jordan Research And Education Institute Of Alta Bates Summit | |
Berkeley, California, United States, 94705 | |
Neuro-Pain Medical Center | |
Fresno, California, United States, 93710 | |
University of Southern California Keck School of Medicine | |
Los Angeles, California, United States, 90033 | |
MS Center of California | |
Newport Beach, California, United States, 92663 | |
UC Davis Health System | |
Sacramento, California, United States, 95817 | |
UCSF Multiple Sclerosis Center | |
San Francisco, California, United States, 94158 | |
United States, Colorado | |
University of Colorado Denver | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Yale New Haven Hospital | |
North Haven, Connecticut, United States, 06473 | |
United States, Florida | |
Nova Clinical Research, LLC | |
Bradenton, Florida, United States, 34209 | |
University of Miami Miller School of Medicine | |
Miami, Florida, United States, 33136 | |
University of South Florida - Neurology | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Northwestern University - Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM) | |
Chicago, Illinois, United States, 60637 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
Rowe Neurology Institute | |
Lenexa, Kansas, United States, 66214 | |
United States, Louisiana | |
Ochsner Health System | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
The Johns Hopkins Outpatient Center | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard Medical School - Brigham and Women's Hospital - Center for Neurologic Diseases | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Wayne State University - Comp Clinic and MS Center | |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
Minneapolis Clinic of Neurology, LTD | |
Golden Valley, Minnesota, United States, 55422 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Holy Name Hospital | |
Teaneck, New Jersey, United States, 07666 | |
United States, New Mexico | |
The University of New Mexico - Multiple Sclerosis Specialty Clinic | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
UBMD Neurology | |
Buffalo, New York, United States, 14203 | |
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS | |
New York, New York, United States, 10029 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
State University of New York (SUNY) | |
Stony Brook, New York, United States, 11794 | |
United States, North Carolina | |
Raleigh Neurology Associates, P.A. | |
Raleigh, North Carolina, United States, 27607 | |
United States, Ohio | |
Cleveland Clinic Mellen Center for MS | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Providence Multiple Sclerosis Center | |
Portland, Oregon, United States, 97225 | |
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
New Orleans Center for Clinical Research | |
Knoxville, Tennessee, United States, 37920 | |
Vanderbilt Comprehensive Multiple Sclerosis Center | |
Nashville, Tennessee, United States, 37215 | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 | |
Central Texas Neurology Consultants | |
Round Rock, Texas, United States, 78681 | |
United States, Virginia | |
University of Virginia Health System | |
Charlottesville, Virginia, United States, 22903 | |
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 | |
Australia, New South Wales | |
Brain and Mind Centre/University of Sydney | |
Sydney, New South Wales, Australia, 2050 | |
Australia, Victoria | |
Austin Hospital | |
Heidelberg, Victoria, Australia, 3084 | |
The Royal Melbourne Hospital | |
Parkville, Victoria, Australia, 3050 | |
Belgium | |
UZ Antwerpen | |
Edegem, Antwerpen, Belgium, 2650 | |
Jessa Ziekenhuis - Campus Virga Jesse | |
Hasselt, Limburg, Belgium, 3500 | |
UZ Gent | |
Halle, Oost-Vlaanderen, Belgium, 9000 | |
Canada, British Columbia | |
Burnaby Hospital | |
Burnaby, British Columbia, Canada, V5G 2X6 | |
Vancouver Hospital and Health Sciences Centre | |
Vancouver, British Columbia, Canada, V6T 2B5 | |
Canada, New Brunswick | |
Hôpital universitaire Dr George L-Dumont university Hospital | |
Moncton, New Brunswick, Canada, E1C 2Z3 | |
Canada, Nova Scotia | |
Nova Scotia Rehabilitation Center | |
Halifax, Nova Scotia, Canada, B3H 4K4 | |
Canada, Ontario | |
Ottawa Hospital General Campus | |
Ottawa, Ontario, Canada, ON K1H 8L6 | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 | |
Canada, Quebec | |
Montreal Neurologic Institute | |
Montreal, Quebec, Canada, H3A 2B4 | |
Hopital de Notre Dame | |
Montréal, Quebec, Canada, H2L 4M1 | |
Czechia | |
doc. MUDr. Radomir Talab, CSc., neurologie | |
Hradec Králové, Czechia, 500 03 | |
Nemocnice Jihlava | |
Jihlava, Czechia, 586 33 | |
Vseobecna fakultni nemocnice v Praze | |
Praha, Czechia, 128 21 | |
Fakultni nemocnice v Motole | |
Praha, Czechia, 150 06 | |
Nemocnice Teplice | |
Teplice, Czechia, 415 29 | |
Germany | |
Universitätsklinikum Leipzig A.ö.R. - Klinik und Poliklinik | |
Leipzig, Sachsen, Germany, 04103 | |
Fachkrankenhaus Hubertusburg | |
Wermsdorf, Sachsen, Germany, 04779 | |
Caritas Krankenhaus | |
Bad Mergentheim, Germany, 97980 | |
Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center | |
Berlin, Germany, 10117 | |
Heinrich-Heine-Universität Düsseldorf | |
Dusseldorf, Germany, 40225 | |
Neuro Centrum Science GmbH | |
Erbach, Germany, 64711 | |
MultipEL Studies Institut für klinische Studien GbR | |
Hamburg, Germany, 22179 | |
Ludwig-Maximilians Universität München | |
München, Germany, 81377 | |
Neuropoint GmbH | |
Ulm, Germany, 89073 | |
Poliklinik für Neurologie Universitätsklinikum Ulm | |
Ulm, Germany, 89081 | |
Hungary | |
Valeomed Kft | |
Esztergom, Hungary, 2500 | |
Italy | |
Ospedale San Raffaele, IRCCS | |
Milano, Italy, 20132 | |
AO S.Andrea, Università degli Studi di Roma La Sapienza | |
Roma, Italy, 00189 | |
Poland | |
Nasz Lekarz Ośrodek Badań Klinicznych | |
Bydgoszcz, Poland, 85-794 | |
COPERNICUS PL sp z o.o.,Szpital im. M.Kopernika Oddział Neurologiczny | |
Gdansk, Poland, 80-803 | |
Twoja Przychodnia Centrum Medyczne Nowa Sol | |
Nowa Sol, Poland, 67-100 | |
Centrum Medyczne Pratia Warszawa | |
Warszawa, Poland, 01-868 | |
Spain | |
Hospital Santa Caterina | |
Salt, Girona, Spain, 17190 | |
Hostipal Universitario Quirónsalud Madrid | |
Pozuelo de Alarcón, Madrid, Spain, 28223 | |
Servicio de Neurología Hospital Vithas Nisa Aljarafe | |
Castilleja de la Cuesta, Sevilla, Spain, 41950 | |
Hospital del Mar Servicio de Neurología | |
Barcelona, Spain, 08003 | |
Hospital Universitari Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Clínico San Carlos | |
Madrid, Spain, 28040 | |
Hospital Regional Universitario de Málaga | |
Malaga, Spain, 29010 | |
Sweden | |
Sahlgrenska Universitetssjukhus - MS Center forskningsenheten | |
Göteborg, Sweden, 413 45 | |
Karolinska University Hospital - Neurologmottagningen | |
Stockholm, Sweden, 171 76 | |
Turkey | |
Ondokuz Mayis University Medical Faculty | |
Samsun, Turkey, 55139 | |
United Kingdom | |
The University of Edinburgh | |
Edinburgh, United Kingdom, EH16 4SB | |
Institute of Neurological Sciences | |
Glasgow, United Kingdom, G51 4TF | |
Barts And The London School Of Medicine And Dentistry Institute | |
London, United Kingdom, E1 2AT | |
University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery | |
London, United Kingdom, WC1N 3BG | |
Tyne Hospitals NHS Foundation | |
Newcastle upon Tyne, United Kingdom, NE1 4LP | |
Salford Royal Hospital | |
Salford, United Kingdom, M6 8HD |
Principal Investigator: | Bruce Cree, MD, PHD | University of California, San Francisco | |
Study Director: | Frederic Sedel, MD, PHD | Medday Pharmaceuticals |
Documents provided by MedDay Pharmaceuticals SA:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | MedDay Pharmaceuticals SA |
ClinicalTrials.gov Identifier: | NCT02936037 |
Other Study ID Numbers: |
MD1003CT2016-01MS-SPI2 |
First Posted: | October 18, 2016 Key Record Dates |
Results First Posted: | November 23, 2020 |
Last Update Posted: | November 23, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
progressive multiple sclerosis MS EDSS TW25 multiple sclerosis |
Biotin Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs |