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 : August 28, 2018
|
Sponsor:
MedDay Pharmaceuticals SA
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized double blind placebo-controlled for at least 15 months but not longer than 27 months study drug administration per patient. The blinded placebo-controlled phase will end when the last patient randomized has completed the Month 15 evaluation (visit 7). Patients who have completed 15 months will be kept on blinded study drug for a maximum of 27 months or until the last study patient completes the Month 15 evaluation, whichever comes first. |
| 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 |
| Estimated Primary Completion Date : | September 2018 |
| Estimated Study Completion Date : | September 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
|
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 |
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 ]
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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
- 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
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
Hide Study Locations
Locations
| United States, Arizona | |
| Barrow Neurology Clinics | |
| Phoenix, Arizona, United States, 85013 | |
| Mayo Clinic Arizona | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Sutter East Bay Medical Foundation | |
| 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, 95817-2307 | |
| UCSF Multiple Sclerosis Center | |
| San Francisco, California, United States, 94117 | |
| 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 South Florida Medical Clinic | |
| 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 | |
| Johns Hopkins Medicine Neurology & Neurosurgery | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Harvard Medical School - Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115-5727 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Minneapolis Clinic of Neurology | |
| Minneapolis, 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 | |
| SUNY Buffalo - University Neurology, Inc | |
| Buffalo, New York, United States, 14203 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10021-0005 | |
| Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS | |
| New York, New York, United States, 10029-6574 | |
| 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 | |
| Cole Neuroscience Center | |
| 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, 75390-8829 | |
| 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, Victoria | |
| Austin Hospital | |
| Heidelberg, Victoria, Australia, 3084 | |
| The Royal Melbourne Hospital | |
| Parkville, Victoria, Australia, 3050 | |
| Australia | |
| Brain and Mind Centre/University of Sydney | |
| Sydney, Australia, 2050 | |
| Belgium | |
| Jessa Ziekenhuis - Campus Virga Jesse | |
| Hasselt, Limburg, Belgium, 3500 | |
| UZ Gent | |
| Halle, Oost-Vlaanderen, Belgium | |
| UZ Antwerpen | |
| Edegem, Belgium, 2650 | |
| Canada, British Columbia | |
| Burnaby Hospital | |
| Burnaby, British Columbia, Canada, V5G 1T4 | |
| 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 8X3 | |
| Canada, Nova Scotia | |
| Nova Scotia Rehabilitation Center | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Ottawa Hospital General Campus | |
| Ottawa, Ontario, Canada, ON K1H 8L6 | |
| Trillium Health Centre | |
| Toronto, Ontario, Canada, L5B 1B8 | |
| Canada, Quebec | |
| Montreal Neurologic Institute | |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Canada | |
| Hopital de Notre Dame | |
| Montréal, Canada, H2L 4M1 | |
| Czechia | |
| Doc. Radomir Talab - neurologist | |
| 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. | |
| 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 | |
| Universitätsklinikum Düsseldorf | |
| Dusseldorf, Germany, 40225 | |
| MultipEL Studies Institut für klinische Studien GbR | |
| Hamburg, Germany, 22179 | |
| Neuro Centrum Science GmbH | |
| Hessen, Germany, 64711 | |
| 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 | |
| Italy | |
| Ospedale San Raffaele, IRCCS | |
| Milano, Italy, 20127 | |
| 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, 71-270 | |
| Centrum Medyczne Pratia Warszawa | |
| Warszawa, Poland, 01-868 | |
| Spain | |
| Hospital Santa Caterina | |
| Girona, Gerona, Spain, 17190 | |
| Hostipal Universitario Quirónsalud Madrid | |
| Pozuelo de Alarcón, Madrid, Spain, 28223 | |
| Servicio de Neurología Hospital Vithas Nisa | |
| 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 | |
| Göteborg, Sweden, 416 85 | |
| Karolinska Institutet | |
| Stockholm, Sweden, SE-171 77 | |
| 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, NE7 7DN | |
| Salford Royal Hospital | |
| Salford, United Kingdom, M6 8HD | |
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 |
Additional Information:
| Responsible Party: | MedDay Pharmaceuticals SA |
| ClinicalTrials.gov Identifier: | NCT02936037 History of Changes |
| Other Study ID Numbers: |
MD1003CT2016-01MS-SPI2 |
| First Posted: | October 18, 2016 Key Record Dates |
| Last Update Posted: | August 28, 2018 |
| Last Verified: | August 2018 |
| 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 |