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

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MD1003 100mg capsule
PLACEBO
Sponsored by
MedDay Pharmaceuticals SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring progressive multiple sclerosis, MS, EDSS, TW25, multiple sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurology Clinics (BNC)
  • Mayo Clinic Scottsdale
  • Jordan Research And Education Institute Of Alta Bates Summit
  • Neuro-Pain Medical Center
  • University of Southern California Keck School of Medicine
  • MS Center of California
  • UC Davis Health System
  • UCSF Multiple Sclerosis Center
  • University of Colorado Denver
  • Yale New Haven Hospital
  • Nova Clinical Research, LLC
  • University of Miami Miller School of Medicine
  • University of South Florida - Neurology
  • Northwestern University - Feinberg School of Medicine
  • University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM)
  • University of Kansas Medical Center
  • Rowe Neurology Institute
  • Ochsner Health System
  • The Johns Hopkins Outpatient Center
  • Harvard Medical School - Brigham and Women's Hospital - Center for Neurologic Diseases
  • Wayne State University - Comp Clinic and MS Center
  • Minneapolis Clinic of Neurology, LTD
  • Washington University School of Medicine
  • Holy Name Hospital
  • The University of New Mexico - Multiple Sclerosis Specialty Clinic
  • UBMD Neurology
  • Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS
  • Columbia University Medical Center
  • University of Rochester Medical Center
  • State University of New York (SUNY)
  • Raleigh Neurology Associates, P.A.
  • Cleveland Clinic Mellen Center for MS
  • Providence Multiple Sclerosis Center
  • Thomas Jefferson University
  • New Orleans Center for Clinical Research
  • Vanderbilt Comprehensive Multiple Sclerosis Center
  • University of Texas Southwestern Medical Center
  • Central Texas Neurology Consultants
  • University of Virginia Health System
  • Virginia Mason Medical Center
  • Brain and Mind Centre/University of Sydney
  • Austin Hospital
  • The Royal Melbourne Hospital
  • UZ Antwerpen
  • Jessa Ziekenhuis - Campus Virga Jesse
  • UZ Gent
  • Burnaby Hospital
  • Vancouver Hospital and Health Sciences Centre
  • Hôpital universitaire Dr George L-Dumont university Hospital
  • Nova Scotia Rehabilitation Center
  • Ottawa Hospital General Campus
  • St. Michael's Hospital
  • Montreal Neurologic Institute
  • Hopital de Notre Dame
  • doc. MUDr. Radomir Talab, CSc., neurologie
  • Nemocnice Jihlava
  • Vseobecna fakultni nemocnice v Praze
  • Fakultni nemocnice v Motole
  • Nemocnice Teplice
  • Universitätsklinikum Leipzig A.ö.R. - Klinik und Poliklinik
  • Fachkrankenhaus Hubertusburg
  • Caritas Krankenhaus
  • Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center
  • Heinrich-Heine-Universität Düsseldorf
  • Neuro Centrum Science GmbH
  • MultipEL Studies Institut für klinische Studien GbR
  • Ludwig-Maximilians Universität München
  • Neuropoint GmbH
  • Poliklinik für Neurologie Universitätsklinikum Ulm
  • Valeomed Kft
  • Ospedale San Raffaele, IRCCS
  • AO S.Andrea, Università degli Studi di Roma La Sapienza
  • Nasz Lekarz Ośrodek Badań Klinicznych
  • COPERNICUS PL sp z o.o.,Szpital im. M.Kopernika Oddział Neurologiczny
  • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Centrum Medyczne Pratia Warszawa
  • Hospital Santa Caterina
  • Hostipal Universitario Quirónsalud Madrid
  • Servicio de Neurología Hospital Vithas Nisa Aljarafe
  • Hospital del Mar Servicio de Neurología
  • Hospital Universitari Vall d'Hebron
  • Hospital Clínico San Carlos
  • Hospital Regional Universitario de Málaga
  • Sahlgrenska Universitetssjukhus - MS Center forskningsenheten
  • Karolinska University Hospital - Neurologmottagningen
  • Ondokuz Mayis University Medical Faculty
  • The University of Edinburgh
  • Institute of Neurological Sciences
  • Barts And The London School Of Medicine And Dentistry Institute
  • University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery
  • Tyne Hospitals NHS Foundation
  • Salford Royal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

GROUP 1

GROUP 2

Arm Description

Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.

MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
CGI-I Score (Clinical Global Impression of Change - Improvement), Evaluated Both by the Patient (SGI) and by the Evaluating Physician (CGI)
Mean Change in TW25 Between M0 and M15

Full Information

First Posted
October 14, 2016
Last Updated
October 29, 2020
Sponsor
MedDay Pharmaceuticals SA
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1. Study Identification

Unique Protocol Identification Number
NCT02936037
Brief Title
Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)
Acronym
SPI2
Official Title
Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision for business purposes
Study Start Date
December 2016 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
April 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedDay Pharmaceuticals SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
progressive multiple sclerosis, MS, EDSS, TW25, multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
PART 1: Total duration of Part 1 is 27 months. The randomized double-blind placebo-controlled period ranges from 15 to 27 months depending upon the randomization date of an individual patient. Once the last month 15 evaluation of the study has been completed, patients will switch to the active drug at the next planned visit. Participants and study personnel will remain blinded as to the original treatment assignment. Maximum duration of double-blind period per patient will be no longer than 27 months. PART 2: At the last evaluation of Part 1 (Visit 11/Month 27) all participants will be offered active treatment in an open label extension for 39 additional months (From V11/M27 to V18/M66). The purpose of the active drug extension is to further define the safety of MD1003.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
642 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
Arm Title
GROUP 2
Arm Type
Experimental
Arm Description
MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
Intervention Type
Drug
Intervention Name(s)
MD1003 100mg capsule
Other Intervention Name(s)
high dose biotin
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
an inactive substance
Primary Outcome Measure Information:
Title
Proportion of Patients Improved on Either Expanded Disability Status Scale (EDSS) or Time to Walk 25 Feet (TW25)
Description
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.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Time to 12-Weeks Confirmed EDSS Progression
Description
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.
Time Frame
3 to 27 months
Title
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
Title
Mean Change in TW25 Between M0 and M15
Time Frame
15 months
Other Pre-specified Outcome Measures:
Title
Brain MRI Changes Between M0 and M15
Time Frame
15 months
Title
Remote Monitoring of Ambulation
Time Frame
27 months
Title
(MSQOL54) & (CAREQOL-MS) Subscores and Composite Scores
Time Frame
15 months
Title
Subscores of the Kurtzke Functional Score
Time Frame
15 months
Title
Symbol Digit Modalities Test (SDMT)
Time Frame
15 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33222767
Citation
Cree BAC, Cutter G, Wolinsky JS, Freedman MS, Comi G, Giovannoni G, Hartung HP, Arnold D, Kuhle J, Block V, Munschauer FE, Sedel F, Lublin FD; SPI2 investigative teams. Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2020 Dec;19(12):988-997. doi: 10.1016/S1474-4422(20)30347-1. Epub 2020 Oct 23.
Results Reference
derived
Links:
URL
http://www.medday-pharma.com
Description
Sponsor

Learn more about this trial

Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)

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