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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04458051
Registration number
NCT04458051
Ethics application status
Date submitted
1/07/2020
Date registered
7/07/2020
Titles & IDs
Public title
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
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Scientific title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
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Secondary ID [1]
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U1111-1238-1318
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Secondary ID [2]
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EFC16035
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Universal Trial Number (UTN)
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Trial acronym
PERSEUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary Progressive Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tolebrutinib
Treatment: Drugs - Placebo
Experimental: SAR442168 - Dose 1 of oral SAR442168 once daily
Placebo comparator: Placebo - Placebo to match the SAR442168 once daily
Treatment: Drugs: Tolebrutinib
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
Treatment: Drugs: Placebo
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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3-month composite Confirmed Disability Progression (cCDP)
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Assessment method [1]
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Time to onset of 3-month cCDP defined as follows:
Increase over at least 3 months of =1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is =5.5, or =0.5 points when the baseline EDSS score is \>5.5, or =20% from the baseline T25-FW, or =20% from the baseline 9-HPT
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Timepoint [1]
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Up to approximately 60 months
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Secondary outcome [1]
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6-month Confirmed Disability Progression (CDP)
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Assessment method [1]
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Time to onset of 6-month CDP as assessed by EDSS score
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Timepoint [1]
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Up to approximately 60 months
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Secondary outcome [2]
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6-month composite Confirmed Disability Progression (cCDP)
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Assessment method [2]
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Time to onset of 6-month cCDP
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Timepoint [2]
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Up to approximately 60 months
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Secondary outcome [3]
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Change in T2 hyperintense lesions by MRI
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Assessment method [3]
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Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)
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Timepoint [3]
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From screening MRI to approximately 60 months
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Secondary outcome [4]
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Time to onset of confirmed disability improvement (CDI)
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Assessment method [4]
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Time to onset of CDI defined as =1.0-point decrease on the EDSS score from baseline confirmed over at least 6 months
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Timepoint [4]
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Up to approximately 60 months
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Secondary outcome [5]
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Percent change in Brain volume (BV)
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Assessment method [5]
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Percent change in brain volume (BV) as detected by brain MRI at the EOS compared to month 6
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Timepoint [5]
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From 6 months up to approximately 60 months
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Secondary outcome [6]
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Change in cognitive function as assessed by SDMT
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Assessment method [6]
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Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT)
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Timepoint [6]
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From Baseline up to approximately 60 months
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Secondary outcome [7]
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Change in cognitive function as assessed by CVLT-II
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Assessment method [7]
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Change in cognitive function at the EOS compared to baseline as assessed by the California Verbal Learning Test II (CVLT-II) where available
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Timepoint [7]
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From Baseline up to approximately 60 months
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Secondary outcome [8]
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Change in Multiple Sclerosis Quality of Life
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Assessment method [8]
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Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline
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Timepoint [8]
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From Baseline up to approximately 60 months
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Secondary outcome [9]
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Safety and Tolerability
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Assessment method [9]
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Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)
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Timepoint [9]
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From screening up to approximately 60 months
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Secondary outcome [10]
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Population pharmacokinetics
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Assessment method [10]
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Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12
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Timepoint [10]
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Months 6, 9 and 12
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Secondary outcome [11]
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Change in plasma neurofilament light chain (NfL)
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Assessment method [11]
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Change in NfL levels from at the EOS compared to baseline
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Timepoint [11]
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From Baseline up to approximately 60 months
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Secondary outcome [12]
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Change in lymphocyte phenotype subsets
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Assessment method [12]
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Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants
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Timepoint [12]
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From Baseline up to approximately 60 months
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Secondary outcome [13]
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Changes in serum Immunoglobulin level
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Assessment method [13]
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Changes in serum Immunoglobulin level at the EOS compared to baseline
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Timepoint [13]
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From Baseline up to approximately 60 months
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Secondary outcome [14]
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Change in serum chitinase-3 like protein 1 (Chi3L1)
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Assessment method [14]
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Change in serum Chi3L1 at EOS compared to baseline
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Timepoint [14]
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From Baseline up to approximately 60 months
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Eligibility
Key inclusion criteria
- 18 to 55 years of age inclusive
* Diagnosis of PPMS according to the 2017 McDonald criteria
* Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive
* Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
* Contraceptive use consistent with local regulations for individuals participating in clinical studies
* Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
* Is not a woman of childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method
* the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication).
* the participant must have access to and be eligible to be treated with ocrelizumab but: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has failed ocrelizumab treatment due to perceived lack of efficacy
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Minimum age
18
Years
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
* Participant has conditions that would adversely affect study participation such as short life expectancy.
* Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
* Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator
* History of malignancy within 5 years prior to screening.
* History of alcohol or drug abuse within 1 year prior to Screening.
* Hospitalized for psychiatric disease within 2 years prior to Screening.
* Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
* A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.
* A platelet count <150 000/µL at the screening visit.
* A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal
* Lymphocyte count below the lower limit of normal at Screening.
* Recent live (attenuated) vaccine within 2 months before the first treatment visit.
* Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
* The participant has received medications/treatments for MS within a specified time frame.
* Receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.
* Receiving anticoagulant or antiplatelet therapy (such as aspirin >81mg/day, clopidogrel, warfarin).
* Contraindications to magnetic resonance imaging (MRI). NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/07/2025
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,TAS
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Recruitment hospital [1]
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Investigational Site Number : 0360005 - Concord
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Recruitment hospital [2]
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Investigational Site Number : 0360006 - St Leonards
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Recruitment hospital [3]
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Investigational Site Number : 0360003 - Hobart
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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7001 - Hobart
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Recruitment outside Australia
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Ramat Gan
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Israel
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State/province [106]
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Safed
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Italy
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Isernia
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Italy
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Cagliari
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Italy
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Catania
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Italy
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Chieti
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Italy
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State/province [111]
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Firenze
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Italy
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Milano
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Italy
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Napoli
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Italy
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Roma
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Japan
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State/province [115]
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Chiba
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Japan
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Fukushima
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Japan
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Iwate
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Toyama
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Latvia
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Riga
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Mexico
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Jalisco
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Mexico
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Mexico city
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Mexico
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Tlalnepantla
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Mexico
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Veracruz
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Netherlands
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Breda
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Netherlands
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State/province [132]
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Groningen
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Netherlands
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Sittard-Geleen
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Norway
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Bergen
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Norway
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Tromsø
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Peru
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State/province [136]
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Lima
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Poland
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Kujawsko-pomorskie
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Poland
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Lódzkie
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Poland
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Mazowieckie
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Poland
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State/province [140]
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Slaskie
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Portugal
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State/province [141]
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Braga
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Portugal
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Leiria
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Portugal
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State/province [143]
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Lisboa
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Portugal
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State/province [144]
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Matosinhos
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Portugal
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Porto
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Portugal
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Santa Maria da Feira
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Romania
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Bucuresti
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Romania
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Campulung
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Romania
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Constanta
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Romania
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Oradea
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Romania
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Targu Mures
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Romania
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Timisoara
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kaliningrad
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Russian Federation
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Kazan
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Pyatigorsk
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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Saransk
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Russian Federation
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Tyumen
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Russian Federation
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Ufa
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Serbia
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Belgrade
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Serbia
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State/province [168]
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Kragujevac
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Serbia
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Nis
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Singapore
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Singapore
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South Africa
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Pretoria
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Spain
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A Coruña [La Coruña]
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Spain
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Andalucia
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Spain
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State/province [174]
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Barcelona [Barcelona]
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Spain
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Bizkaia
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Spain
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Girona [Gerona]
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Spain
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Las Palmas
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Spain
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Madrid
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Spain
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Córdoba
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Spain
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Malaga
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Spain
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Murcia
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Spain
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Palma de Mallorca
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Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Motala
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Turkey
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Ankara
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Turkey
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Eskisehir
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Turkey
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Hatay
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Izmit
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Kutahya
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Turkey
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Mersin
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Turkey
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Samsun
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Ukraine
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Chernivtsi
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Vinnytsya
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Ukraine
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Zhytormyr
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United Kingdom
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Kent
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United Kingdom
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London, City Of
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United Kingdom
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Neath Port Talbot
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United Kingdom
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Nottinghamshire
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United Kingdom
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Oxfordshire
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United Kingdom
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Vale Of Glamorgan, The
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United Kingdom
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Bristol
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United Kingdom
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168
Query!
Trial website
https://clinicaltrials.gov/study/NCT04458051
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Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Sciences & Operations
Query!
Address
0
0
Sanofi
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
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Email
0
0
Query!
Contact person for public queries
Name
0
0
Trial Transparency email recommended (Toll free number for US & Canada)
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
800-633-1610
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Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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When will data be available (start and end dates)?
Query!
Available to whom?
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Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04458051