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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02936037




Registration number
NCT02936037
Ethics application status
Date submitted
14/10/2016
Date registered
18/10/2016

Titles & IDs
Public title
Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)
Scientific title
Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study
Secondary ID [1] 0 0
MD1003CT2016-01MS-SPI2
Universal Trial Number (UTN)
Trial acronym
SPI2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PLACEBO

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

Experimental: GROUP 2 - MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.


Treatment: Drugs: PLACEBO
an inactive substance
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Patients Improved on Either Expanded Disability Status Scale (EDSS) or Time to Walk 25 Feet (TW25)
Timepoint [1] 0 0
15 months
Secondary outcome [1] 0 0
Time to 12-Weeks Confirmed EDSS Progression
Timepoint [1] 0 0
3 to 27 months
Secondary outcome [2] 0 0
CGI-I Score (Clinical Global Impression of Change - Improvement), Evaluated Both by the Patient (SGI) and by the Evaluating Physician (CGI)
Timepoint [2] 0 0
15 months
Secondary outcome [3] 0 0
Mean Change in TW25 Between M0 and M15
Timepoint [3] 0 0
15 months

Eligibility
Key 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"
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/04/2020
Sample size
Target
Accrual to date
Final
642
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Brain and Mind Centre/University of Sydney - Sydney
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Connecticut
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Louisiana
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Massachusetts
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New Mexico
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Washington
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Antwerpen
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Nova Scotia
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Quebec
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Czechia
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Hradec Králové
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Jihlava
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Praha
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Teplice
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Germany
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Sachsen
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Berlin
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Erbach
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Hamburg
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München
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Ulm
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Hungary
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Esztergom
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Milano
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Italy
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Roma
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Bydgoszcz
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Gdansk
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Nowa Sol
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Girona
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Barcelona
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Malaga
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Göteborg
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Sweden
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Stockholm
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Turkey
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Samsun
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United Kingdom
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Edinburgh
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Glasgow
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London
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Newcastle upon Tyne
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United Kingdom
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Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedDay Pharmaceuticals SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce Cree, MD, PHD
Address 0 0
University of California, San Francisco
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02936037