Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) (SPI2)

October 29, 2020 updated by: MedDay Pharmaceuticals SA

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

642

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Brain and Mind Centre/University of Sydney
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Jessa Ziekenhuis - Campus Virga Jesse
    • Oost-Vlaanderen
      • Halle, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 2X6
        • Burnaby Hospital
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Vancouver Hospital and Health Sciences Centre
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 2Z3
        • Hôpital universitaire Dr George L-Dumont university Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
        • Nova Scotia Rehabilitation Center
    • Ontario
      • Ottawa, Ontario, Canada, ON K1H 8L6
        • Ottawa Hospital General Campus
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Montreal Neurologic Institute
      • Montréal, Quebec, Canada, H2L 4M1
        • Hopital de Notre Dame
  • Czechia
      • Hradec Králové, Czechia, 500 03
        • doc. MUDr. Radomir Talab, CSc., neurologie
      • Jihlava, Czechia, 586 33
        • Nemocnice Jihlava
      • Praha, Czechia, 128 21
        • Vseobecna fakultni nemocnice v Praze
      • Praha, Czechia, 150 06
        • Fakultni nemocnice v Motole
      • Teplice, Czechia, 415 29
        • Nemocnice Teplice
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Caritas Krankenhaus
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center
      • Dusseldorf, Germany, 40225
        • Heinrich-Heine-Universität Düsseldorf
      • Erbach, Germany, 64711
        • Neuro Centrum Science GmbH
      • Hamburg, Germany, 22179
        • MultipEL Studies Institut für klinische Studien GbR
      • München, Germany, 81377
        • Ludwig-Maximilians Universitat Munchen
      • Ulm, Germany, 89073
        • Neuropoint GmbH
      • Ulm, Germany, 89081
        • Poliklinik für Neurologie Universitätsklinikum Ulm
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitätsklinikum Leipzig A.ö.R. - Klinik und Poliklinik
      • Wermsdorf, Sachsen, Germany, 04779
        • Fachkrankenhaus Hubertusburg
  • Hungary
      • Esztergom, Hungary, 2500
        • VALEOMED Kft
  • Italy
      • Milano, Italy, 20132
        • Ospedale San Raffaele, IRCCS
      • Roma, Italy, 00189
        • AO S.Andrea, Università degli Studi di Roma La Sapienza
  • Poland
      • Bydgoszcz, Poland, 85-794
        • Nasz Lekarz Ośrodek Badań Klinicznych
      • Gdansk, Poland, 80-803
        • COPERNICUS PL sp z o.o.,Szpital im. M.Kopernika Oddział Neurologiczny
      • Nowa Sol, Poland, 67-100
        • Twoja Przychodnia Centrum Medyczne Nowa Sol
      • Warszawa, Poland, 01-868
        • Centrum Medyczne Pratia Warszawa
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08003
        • Hospital del Mar Servicio de Neurología
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de Malaga
    • Girona
      • Salt, Girona, Spain, 17190
        • Hospital Santa Caterina
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hostipal Universitario Quirónsalud Madrid
    • Sevilla
      • Castilleja de la Cuesta, Sevilla, Spain, 41950
        • Servicio de Neurología Hospital Vithas Nisa Aljarafe
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhus - MS Center forskningsenheten
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital - Neurologmottagningen
  • Turkey
      • Samsun, Turkey, 55139
        • Ondokuz Mayis University Medical Faculty
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SB
        • The University of Edinburgh
      • Glasgow, United Kingdom, G51 4TF
        • Institute of Neurological Sciences
      • London, United Kingdom, E1 2AT
        • Barts And The London School Of Medicine And Dentistry Institute
      • London, United Kingdom, WC1N 3BG
        • University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Tyne Hospitals NHS Foundation
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurology Clinics (BNC)
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Scottsdale
    • California
      • Berkeley, California, United States, 94705
        • Jordan Research And Education Institute Of Alta Bates Summit
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California Keck School of Medicine
      • Newport Beach, California, United States, 92663
        • MS Center of California
      • Sacramento, California, United States, 95817
        • UC Davis Health System
      • San Francisco, California, United States, 94158
        • UCSF Multiple Sclerosis Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Connecticut
      • North Haven, Connecticut, United States, 06473
        • Yale New Haven Hospital
    • Florida
      • Bradenton, Florida, United States, 34209
        • Nova Clinical Research, LLC
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • Tampa, Florida, United States, 33612
        • University of South Florida - Neurology
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University - Feinberg School of Medicine
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM)
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Lenexa, Kansas, United States, 66214
        • Rowe Neurology Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health System
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Outpatient Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Harvard Medical School - Brigham and Women's Hospital - Center for Neurologic Diseases
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University - Comp Clinic and MS Center
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Minneapolis Clinic of Neurology, Ltd
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • The University of New Mexico - Multiple Sclerosis Specialty Clinic
    • New York
      • Buffalo, New York, United States, 14203
        • UBMD Neurology
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794
        • State University of New York (SUNY)
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates, P.A.
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Mellen Center for MS
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Multiple Sclerosis Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • New Orleans Center for Clinical Research
      • Nashville, Tennessee, United States, 37215
        • Vanderbilt Comprehensive Multiple Sclerosis Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology Consultants
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • high dose biotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 to 27 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
15 months
Mean Change in TW25 Between M0 and M15
Time Frame: 15 months
15 months

Other Outcome Measures

Outcome Measure
Time Frame
Brain MRI Changes Between M0 and M15
Time Frame: 15 months
15 months
Remote Monitoring of Ambulation
Time Frame: 27 months
27 months
(MSQOL54) & (CAREQOL-MS) Subscores and Composite Scores
Time Frame: 15 months
15 months
Subscores of the Kurtzke Functional Score
Time Frame: 15 months
15 months
Symbol Digit Modalities Test (SDMT)
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedDay Pharmaceuticals SA

Investigators

  • Principal Investigator: Bruce Cree, MD, PHD, University of California, San Francisco
  • Study Director: Frederic Sedel, MD, PHD, Medday Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

April 23, 2020

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD1003CT2016-01MS-SPI2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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