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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02936037
Recruitment Status : Active, not recruiting
First Posted : October 18, 2016
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA

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

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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 : August 9, 2019
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Biotin

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




Primary Outcome Measures :
  1. 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 :
  1. 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.


  2. 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 ]
  3. Mean change in TW25 between M0 and M15 [ Time Frame: 15 months ]

Other Outcome Measures:
  1. Brain MRI changes between M0 and M15 [ Time Frame: 15 months ]
  2. Remote monitoring of ambulation [ Time Frame: 27 months ]
  3. (MSQOL54) & (CAREQOL-MS) subscores and composite scores [ Time Frame: 15 months ]
  4. Subscores of the Kurtzke functional score [ Time Frame: 15 months ]
  5. Symbol digit modalities test (SDMT) [ Time Frame: 15 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 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

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


Locations
Hide Hide 92 study locations
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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
Sponsors and Collaborators
MedDay Pharmaceuticals SA
Investigators
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Principal Investigator: Bruce Cree, MD, PHD University of California, San Francisco
Study Director: Frederic Sedel, MD, PHD Medday Pharmaceuticals
Additional Information:
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Responsible Party: MedDay Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02936037    
Other Study ID Numbers: MD1003CT2016-01MS-SPI2
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
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:
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Biotin
Multiple Sclerosis
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
Nutrients
Growth Substances
Physiological Effects of Drugs