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Trial record 1 of 1 for:    MD1003 | Recruiting Studies | Multiple Sclerosis | United Kingdom
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Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) (SPI2)

This study is currently recruiting participants.
Verified September 2017 by MedDay Pharmaceuticals SA
Sponsor:
ClinicalTrials.gov Identifier:
NCT02936037
First Posted: October 18, 2016
Last Update Posted: October 9, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA
  Purpose
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 Intervention Phase
Multiple Sclerosis Drug: MD1003 100mg capsule Drug: PLACEBO Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized double blind placebo-controlled for at least 15 months, followed by an open label extension phase of up to 12 months.

The placebo-controlled phase, will end when the last patient randomized will perform his 15 months evaluation (visit 7). Then all patients will be treated with the active drug during an open-label extension phase for a total study duration of 27 months.

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

Resource links provided by NLM:


Further study details as provided by MedDay Pharmaceuticals SA:

Primary Outcome Measures:
  • 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:
  • Time to EDSS progression confirmed at 12 weeks [ Time Frame: 15 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 ]
  • Mean change in TW25 between M0 and M15 [ Time Frame: 15 months ]

Other Outcome Measures:
  • Brain MRI changes between M0 and M15 [ Time Frame: 15 months ]
  • Remote monitoring of ambulation [ Time Frame: 15 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 ]

Estimated Enrollment: 600
Actual Study Start Date: December 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: GROUP 1
Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months at least, then switch to MD1003 100mg capsule, 1 capsule tid for up to 12 months
Drug: MD1003 100mg capsule
Other Name: high dose biotin
Drug: PLACEBO
an inactive substance
Experimental: GROUP 2
MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months at least (double blind period) and then for all patients in open label extension for up to 12 months
Drug: MD1003 100mg capsule
Other Name: high dose biotin

  Eligibility

Information from the National Library of Medicine

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)
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
  • 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 botulinium 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
  Contacts and Locations
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


Contacts
Contact: abdelkarim Bendarraz clinical.trials@medday-pharma.com

  Hide Study Locations
Locations
United States, Arizona
Barrow Neurology Clinics Recruiting
Phoenix, Arizona, United States, 85013
Principal Investigator: Mark Agius, MD         
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Principal Investigator: Jonathan Carter, MD         
United States, California
Sutter East Bay Medical Foundation Recruiting
Berkeley, California, United States, 94705
Principal Investigator: Joanna Cooper, MD         
Neuro-Pain Medical Center Not yet recruiting
Fresno, California, United States, 93710
Principal Investigator: Perminder Bhatia, MD         
University of Southern California Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Lilyana Amezcua, MD         
MS Center of California Recruiting
Newport Beach, California, United States, 92663
Principal Investigator: Daniel S Bandari, MD         
UC Davis Health System Recruiting
Sacramento, California, United States, 95817-2307
Principal Investigator: Michelle Apperson, MD         
UCSF Multiple Sclerosis Center Recruiting
San Francisco, California, United States, 94117
Principal Investigator: Bruce Cree, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: John Corboy, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
North Haven, Connecticut, United States, 06473
Principal Investigator: Sharon Stoll, MD         
United States, Florida
Nova Clinical Research, LLC Recruiting
Bradenton, Florida, United States, 34209
Principal Investigator: Sanjay Yathiraj, MD         
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Kottil Rammohan, MD         
University South Florida Medical Clinic Not yet recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Derrick Robertson, MD         
United States, Illinois
Northwestern University - Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Bruce Cohen, MD         
University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM) Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Anthony Reder, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Sharon Lynch, MD         
Rowe Neurology Institute Recruiting
Lenexa, Kansas, United States, 66214
Principal Investigator: Vernon Rowe, MD         
United States, Louisiana
Ochner Health System Not yet recruiting
New Orleans, Louisiana, United States, 70121
Principal Investigator: Bridget Bagert, MD         
United States, Maryland
Johns Hopkins Medicine Neurology & Neurosurgery Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Shiv Saidha, MD         
United States, Massachusetts
Harvard Medical School - Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115-5727
Principal Investigator: Christopher Severson, MD         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Evanthia Bernitsas, MD         
United States, Minnesota
Clinical Neuroscience Research Unit Not yet recruiting
Minneapolis, Minnesota, United States, 55414
Principal Investigator: Adam Carpenter, MD         
Minneapolis Clinic of Neurology Not yet recruiting
Minneapolis, Minnesota, United States, 55422
Principal Investigator: Jonathan Calkwood, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Robert Naismith, MD         
United States, New Jersey
Holy Name Hospital Recruiting
Teaneck, New Jersey, United States, 07666
Principal Investigator: Mary Ann Picone, MD         
United States, New Mexico
The University of New Mexico - Multiple Sclerosis Specialty Clinic Recruiting
Albuquerque, New Mexico, United States, 87106
Principal Investigator: Corey Ford, MD         
United States, New York
SUNY Buffalo - University Neurology, Inc Recruiting
Buffalo, New York, United States, 14203
Principal Investigator: Bianca Weinstock-Guttman, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10021-0005
Principal Investigator: Claire Riley, MD         
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS Recruiting
New York, New York, United States, 10029-6574
Principal Investigator: Aaron E Miller, MD         
Sub-Investigator: Fred D Lublin, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Sub-Investigator: Andrew Goodman, MD         
Principal Investigator: Lawrence Samkoff, MD         
State University of New York (SUNY) Recruiting
Stony Brook, New York, United States, 11794
Principal Investigator: Patricia Coyle, MD         
United States, North Carolina
Raleigh Neurology Associates, P.A. Recruiting
Raleigh, North Carolina, United States, 27607
Principal Investigator: Mitchell Freedman, MD         
United States, Ohio
Cleveland Clinic Main Campus Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Alex Rae-Grant, MD         
United States, Oregon
Providence Multiple Sclerosis Center Recruiting
Portland, Oregon, United States, 97225
Principal Investigator: Kyle Smoot, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Thomas Leist, MD         
United States, Rhode Island
Rhode Island Hospital Not yet recruiting
Providence, Rhode Island, United States, 02903
Principal Investigator: Jonathan Cahill, MD         
United States, Tennessee
Cole Neuroscience Center Recruiting
Knoxville, Tennessee, United States, 37920
Principal Investigator: Randy Trudell, MD         
Vanderbilt Comprehensive Multiple Sclerosis Center Recruiting
Nashville, Tennessee, United States, 37215
Principal Investigator: Harold Moses, MD         
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390-8829
Principal Investigator: Benjamin Greenberg, MD         
Central Texas Neurology Consultants Recruiting
Round Rock, Texas, United States, 78681
Principal Investigator: Fox Edward, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
Principal Investigator: Myla Goldman, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Principal Investigator: Kita Mariko, MD         
Canada, British Columbia
Burnaby Hospital Not yet recruiting
Burnaby, British Columbia, Canada, V5G 1T4
Principal Investigator: Galina Vorobeychik, MD         
Vancouver Hospital and Health Sciences Centre Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Principal Investigator: Virginia Devonshire, MD         
Canada, New Brunswick
Hôpital universitaire Dr George L-Dumont university Hospital Not yet recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Principal Investigator: Ludivine Witkowski, MD         
Canada, Nova Scotia
Nova Scotia Rehabilitation Center Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Principal Investigator: Roger McKelvey, MD         
Canada, Ontario
Ottawa Hospital General Campus Recruiting
Ottawa, Ontario, Canada, ON K1H 8L6
Principal Investigator: Mark Freedman, MD         
Trillium Health Centre Recruiting
Toronto, Ontario, Canada, L5B 1B8
Principal Investigator: Daniel Selchen, MD         
Canada, Quebec
Montreal Neurologic Institute Recruiting
Montreal, Quebec, Canada, H3A 2B4
Principal Investigator: Paul Giacomini, MD         
Canada
Hopital de Notre Dame Recruiting
Montréal, Canada, H2L 4M1
Principal Investigator: J.Marc Girard, MD         
Czechia
Doc. Radomir Talab - neurologist Recruiting
Hradec Králové, Czechia, 500 03
Principal Investigator: Radomir Talab, MD         
Nemocnice Jihlava Recruiting
Jihlava, Czechia, 586 33
Principal Investigator: Radek Ampapa, MD         
Vseobecna fakultni nemocnice v Praze Recruiting
Praha, Czechia, 128 21
Principal Investigator: Jana Lizrova Preiningerova, MD         
Fakultni nemocnice v Motole Recruiting
Praha, Czechia, 150 06
Principal Investigator: Eva Meluzinova, MD         
Nemocnice Teplice Not yet recruiting
Teplice, Czechia, 415 29
Principal Investigator: Marta Vachova, MD         
Germany
Fachkrankenhaus Hubertusburg Recruiting
Wermsdorf, Sachsen, Germany, 04779
Principal Investigator: Wolfgang Köhler, MD         
Caritas Krankenhaus Recruiting
Bad Mergentheim, Germany, 97980
Principal Investigator: Mathias Buttmann, MD         
Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center Recruiting
Berlin, Germany, 10117
Principal Investigator: Friedemann Paul, MD         
Universitätsklinikum Düsseldorf Recruiting
Dusseldorf, Germany, 40225
Principal Investigator: Aktas Orhan, MD         
Multiple Studies Institut für klinische Studien GbR Recruiting
Hamburg, Germany, 22179
Neuro Centrum Science GmbH Recruiting
Hessen, Germany, 64711
Principal Investigator: Gerd Reifschneider, MD         
Ludwig-Maximilians Universität München Recruiting
München, Germany, 81377
Principal Investigator: Tania Kümpfel, MD         
Neuropoint GmbH Recruiting
Ulm, Germany, 89073
Principal Investigator: Daniela Rau, MD         
Poliklinik für Neurologie Oberer Eselsberg 45 Recruiting
Ulm, Germany, 89081
Principal Investigator: Tumani Hayrettin, MD         
Italy
Ospedale San Raffaele, IRCCS Recruiting
Milano, Italy, 20127
Principal Investigator: Giancarlo Comi, MD         
AO S.Andrea, Università degli Studi di Roma La Sapienza Recruiting
Roma, Italy, 00189
Principal Investigator: Carlo Pozzilli, MD         
Spain
Hospital Santa Caterina Not yet recruiting
Girona, Gerona, Spain, 17190
Principal Investigator: Lluís Ramió i Torrentá, MD         
Hostipal Universitario Quirónsalud Madrid Not yet recruiting
Pozuelo de Alarcón, Madrid, Spain, 28223
Principal Investigator: Rafael Arroyo, MD         
Hospital General Universitario de Alicante Not yet recruiting
Alicante, Spain, 03010
Principal Investigator: Ángel Pérez-Sempere, MD         
Hospital del Mar Servicio de Neurología Recruiting
Barcelona, Spain, 08003
Principal Investigator: Jose Martínez Rodríguez, MD         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: Xavier Montalbán, MD         
Hospital General de Málaga Recruiting
Malaga, Spain, 29010
Principal Investigator: Victoria Fernández Sánchez, MD         
Hospital Universitario Virgen de la Macarena Not yet recruiting
Sevilla, Spain, 41009
Principal Investigator: Guillermo Izquierdo Ayuso, MD         
Sweden
Sahlgrenska Universitetssjukhus Recruiting
Göteborg, Sweden, 416 85
Principal Investigator: Jan Lycke, MD         
Karolinska Institutet Recruiting
Stockholm, Sweden, SE-171 77
Principal Investigator: Lou Brundin, MD         
United Kingdom
The University of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SB
Principal Investigator: Don Mahad, MD         
Institute of Neurological Sciences Recruiting
Glasgow, United Kingdom, G51 4TF
Principal Investigator: Webb Stewart, MD         
Barts And The London School Of Medicine And Dentistry Institute Recruiting
London, United Kingdom, E1 2AT
Principal Investigator: Schmierer Klaus, MD         
University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery Recruiting
London, United Kingdom, WC1N 3BG
Principal Investigator: Ahmed Toosy, MD         
Tyne Hospitals NHS Foundation Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Principal Investigator: Joe Guadagno, MD         
Salford Royal Hospital Recruiting
Salford, United Kingdom, M6 8HD
Principal Investigator: Adrian Pace, MD         
Sponsors and Collaborators
MedDay Pharmaceuticals SA
Investigators
Principal Investigator: Bruce Cree, MD, PHD University of California, San Francisco
Study Director: Frederic Sedel, MD, PHD Medday Pharmaceuticals
  More Information

Additional Information:
Responsible Party: MedDay Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02936037     History of Changes
Other Study ID Numbers: MD1003CT2016-01MS-SPI2
First Submitted: October 14, 2016
First Posted: October 18, 2016
Last Update Posted: October 9, 2017
Last Verified: September 2017
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:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases