Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)



Status:Active, not recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 65
Updated:8/30/2018
Start Date:December 2016
End Date:September 2019

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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.


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
We found this trial at
41
sites
Portland, Oregon 97225
Principal Investigator: Kyle Smoot, MD
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Evanthia Bernitsas, MD
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
Principal Investigator: Perminder Bhatia, MD
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: Kottil Rammohan, MD
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Albuquerque, New Mexico 87106
Principal Investigator: Corey Ford, MD
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: John Corboy, MD
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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1800 Orleans Street
Baltimore, Maryland 21287
Principal Investigator: Shiv Saidha, MD
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Berkeley, California 94705
Principal Investigator: Joanna Cooper, MD
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Boston, Massachusetts 02115
Principal Investigator: Christopher Severson, MD
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Bradenton, Florida 34209
Principal Investigator: Sanjay Yathiraj, MD
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Buffalo, New York 14203
Principal Investigator: Bianca Weinstock-Guttman, MD
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Myla Goldman, MD
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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5758 South Maryland Avenue
Chicago, Illinois 60637
Principal Investigator: Anthony Reder, MD
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Bruce Cohen, MD
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Cleveland, Ohio 44195
Principal Investigator: Devon Conway, MD
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Benjamin Greenberg, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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145 Studley Road
Heidelberg, Victoria 3084
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Sharon Lynch, MD
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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1928 Alcoa Hwy
Knoxville, Tennessee 37920
Principal Investigator: Randy Trudell, MD
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Lenexa, Kansas 66214
Principal Investigator: Vernon Rowe, MD
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Los Angeles, California 90033
Principal Investigator: Lilyana Amezcua, MD
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Minneapolis, Minnesota 55422
Principal Investigator: Jonathan Calkwood, MD
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3810 Bedford Avenue
Nashville, Tennessee 37215
Principal Investigator: Harold Moses, MD
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New Orleans, Louisiana 70121
Principal Investigator: Bridget Bagert, MD
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5 East 98th Street
New York, New York 10029
Principal Investigator: Aaron E Miller, MD
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Claire Riley, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newport Beach, California 92663
Principal Investigator: Daniel S Bandari, MD
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8 Devine Street
North Haven, Connecticut 06473
Principal Investigator: Sharon Stoll, MD
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Thomas Leist, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85013
Principal Investigator: Aimee Borazanci, MD
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Raleigh, North Carolina 27607
Principal Investigator: Mitchell Freedman, MD
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Round Rock, Texas 78681
Principal Investigator: Fox Edward, MD
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Sacramento, California 95817
Principal Investigator: Michelle Apperson, MD
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Robert Naismith, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94518
Principal Investigator: Bruce Cree, MD
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Jonathan Carter, MD
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Kita Mariko, MD
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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100 Nicolls Road
Stony Brook, New York 11794
Principal Investigator: Patricia Coyle, MD
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13330 USF Laurel Drive
Tampa, Florida 33612
Principal Investigator: Derrick Robertson, MD
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Teaneck, New Jersey 07666
Principal Investigator: Mary Ann Picone, MD
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