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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02936037
Other study ID # MD1003CT2016-01MS-SPI2
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 2016
Est. completion date April 23, 2020

Study information

Verified date October 2020
Source MedDay Pharmaceuticals SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Terminated
Enrollment 642
Est. completion date April 23, 2020
Est. primary completion date November 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
MD1003 100mg capsule

PLACEBO
an inactive substance

Locations

Country Name City State
Australia Austin Hospital Heidelberg Victoria
Australia The Royal Melbourne Hospital Parkville Victoria
Australia Brain and Mind Centre/University of Sydney Sydney New South Wales
Belgium UZ Antwerpen Edegem Antwerpen
Belgium UZ Gent Halle Oost-Vlaanderen
Belgium Jessa Ziekenhuis - Campus Virga Jesse Hasselt Limburg
Canada Burnaby Hospital Burnaby British Columbia
Canada Nova Scotia Rehabilitation Center Halifax Nova Scotia
Canada Hôpital universitaire Dr George L-Dumont university Hospital Moncton New Brunswick
Canada Montreal Neurologic Institute Montreal Quebec
Canada Hopital de Notre Dame Montréal Quebec
Canada Ottawa Hospital General Campus Ottawa Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada Vancouver Hospital and Health Sciences Centre Vancouver British Columbia
Czechia doc. MUDr. Radomir Talab, CSc., neurologie Hradec Králové
Czechia Nemocnice Jihlava Jihlava
Czechia Fakultni nemocnice v Motole Praha
Czechia Vseobecna fakultni nemocnice v Praze Praha
Czechia Nemocnice Teplice Teplice
Germany Caritas Krankenhaus Bad Mergentheim
Germany Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center Berlin
Germany Heinrich-Heine-Universität Düsseldorf Dusseldorf
Germany Neuro Centrum Science GmbH Erbach
Germany MultipEL Studies Institut für klinische Studien GbR Hamburg
Germany Universitätsklinikum Leipzig A.ö.R. - Klinik und Poliklinik Leipzig Sachsen
Germany Ludwig-Maximilians Universität München München
Germany Neuropoint GmbH Ulm
Germany Poliklinik für Neurologie Universitätsklinikum Ulm Ulm
Germany Fachkrankenhaus Hubertusburg Wermsdorf Sachsen
Hungary Valeomed Kft Esztergom
Italy Ospedale San Raffaele, IRCCS Milano
Italy AO S.Andrea, Università degli Studi di Roma La Sapienza Roma
Poland Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz
Poland COPERNICUS PL sp z o.o.,Szpital im. M.Kopernika Oddzial Neurologiczny Gdansk
Poland Twoja Przychodnia Centrum Medyczne Nowa Sol Nowa Sol
Poland Centrum Medyczne Pratia Warszawa Warszawa
Spain Hospital del Mar Servicio de Neurología Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Servicio de Neurología Hospital Vithas Nisa Aljarafe Castilleja de la Cuesta Sevilla
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Regional Universitario de Málaga Malaga
Spain Hostipal Universitario Quirónsalud Madrid Pozuelo de Alarcón Madrid
Spain Hospital Santa Caterina Salt Girona
Sweden Sahlgrenska Universitetssjukhus - MS Center forskningsenheten Göteborg
Sweden Karolinska University Hospital - Neurologmottagningen Stockholm
Turkey Ondokuz Mayis University Medical Faculty Samsun
United Kingdom The University of Edinburgh Edinburgh
United Kingdom Institute of Neurological Sciences Glasgow
United Kingdom Barts And The London School Of Medicine And Dentistry Institute London
United Kingdom University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery London
United Kingdom Tyne Hospitals NHS Foundation Newcastle upon Tyne
United Kingdom Salford Royal Hospital Salford
United States The University of New Mexico - Multiple Sclerosis Specialty Clinic Albuquerque New Mexico
United States University of Colorado Denver Aurora Colorado
United States The Johns Hopkins Outpatient Center Baltimore Maryland
United States Jordan Research And Education Institute Of Alta Bates Summit Berkeley California
United States Harvard Medical School - Brigham and Women's Hospital - Center for Neurologic Diseases Boston Massachusetts
United States Nova Clinical Research, LLC Bradenton Florida
United States UBMD Neurology Buffalo New York
United States University of Virginia Health System Charlottesville Virginia
United States Northwestern University - Feinberg School of Medicine Chicago Illinois
United States University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM) Chicago Illinois
United States Cleveland Clinic Mellen Center for MS Cleveland Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Wayne State University - Comp Clinic and MS Center Detroit Michigan
United States Neuro-Pain Medical Center Fresno California
United States Minneapolis Clinic of Neurology, LTD Golden Valley Minnesota
United States University of Kansas Medical Center Kansas City Kansas
United States New Orleans Center for Clinical Research Knoxville Tennessee
United States Rowe Neurology Institute Lenexa Kansas
United States University of Southern California Keck School of Medicine Los Angeles California
United States University of Miami Miller School of Medicine Miami Florida
United States Vanderbilt Comprehensive Multiple Sclerosis Center Nashville Tennessee
United States Ochsner Health System New Orleans Louisiana
United States Columbia University Medical Center New York New York
United States Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS New York New York
United States MS Center of California Newport Beach California
United States Yale New Haven Hospital North Haven Connecticut
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Barrow Neurology Clinics (BNC) Phoenix Arizona
United States Providence Multiple Sclerosis Center Portland Oregon
United States Raleigh Neurology Associates, P.A. Raleigh North Carolina
United States University of Rochester Medical Center Rochester New York
United States Central Texas Neurology Consultants Round Rock Texas
United States UC Davis Health System Sacramento California
United States Washington University School of Medicine Saint Louis Missouri
United States UCSF Multiple Sclerosis Center San Francisco California
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States Virginia Mason Medical Center Seattle Washington
United States State University of New York (SUNY) Stony Brook New York
United States University of South Florida - Neurology Tampa Florida
United States Holy Name Hospital Teaneck New Jersey

Sponsors (1)

Lead Sponsor Collaborator
MedDay Pharmaceuticals SA

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Germany,  Hungary,  Italy,  Poland,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Brain MRI Changes Between M0 and M15 15 months
Other Remote Monitoring of Ambulation 27 months
Other (MSQOL54) & (CAREQOL-MS) Subscores and Composite Scores 15 months
Other Subscores of the Kurtzke Functional Score 15 months
Other Symbol Digit Modalities Test (SDMT) 15 months
Primary 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.
15 months
Secondary 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.
3 to 27 months
Secondary CGI-I Score (Clinical Global Impression of Change - Improvement), Evaluated Both by the Patient (SGI) and by the Evaluating Physician (CGI) 15 months
Secondary Mean Change in TW25 Between M0 and M15 15 months
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Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
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