CURRENT RECRUITING TRIALS
For more information about recruiting trials, contact the MS Team at ms-cru.neuro@mcgill.ca.
Relapsing Remitting MS
FENHANCE
The purpose of this study is to compare the effects, good or bad, of fenebrutinib versus teriflunomide on patients with RMS.
For this study, 734 male and female participants will be recruited globally. The participants will be aged between 18-55 years.
INNODEM EYE TRACKING
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of multiple sclerosis and associated cognitive changes.
Primary Progressive MS
CALLIPER
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main
Treatment Period: Up to 120 weeks (approximately 2 years)
Open Label Extension Period: Up to approximately 8 years
FENTREPID
The purpose of this study is to compare the effects, good or bad, of fenebrutinib versus ocrelizumab on patients with PPMS. In this study, you will get fenebrutinib (or placebo) and ocrelizumab (or placebo)
For this study, 946 male and female participants will be recruited globally. The participants will be aged between 18-65 years.
PERSEUS
The purpose of this study is to see if the study drug works to delay the progression of disability in people with PPMS compared to placebo and has an acceptable safety profile.
For this study, approximately 990 male and female participants with PPMS will be recruited at numerous sites worldwide including Canada. The participants will be aged between 18-55 years.
Secondary Progressive MS
CALLIPER
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main
Treatment Period: Up to 120 weeks (approximately 2 years)
Open Label Extension Period: Up to approximately 8 years
FENHANCE
The purpose of this study is to compare the effects, good or bad, of fenebrutinib versus teriflunomide on patients with RMS.
For this study, 734 male and female participants will be recruited globally. The participants will be aged between 18-55 years.
INNODEM EYE TRACKING
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of multiple sclerosis and associated cognitive changes.
NMOSD
SAKURA BONSAI
A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention
The objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab (RTX) (or its biosimilar).
MOGAD
Pediatric MS
NEOS
The purpose of this study is to compare the effects, good or bad, of Ofatumumab and Siponimod compared to Fingolimod in pediatric patients with MS.
The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 180 participants with multiple sclerosis.
UPCOMING TRIALS
Relapsing Remitting MS
MAGNIFY-EXT
The purpose of this study is to evaluate the long-term disease activity and to further explore the long-term effect and safety during Year 3 and 4 after treatment with Mavenclad from the MAGNIFY study (Years 1 and 2).
For this study, approximately 250 male and female participants will be recruited at 49 sites in Austria, Czech Republic, Finland, France, Germany, Hungary, Italy, Poland, Spain, Sweden, and the United Kingdom, as well as Australia, Canada and Israel. The participants will be aged 18 years and over.
Primary Progressive MS
Secondary Progressive MS
To come
NMOSD
ROCHE SAKURABONZAI
The objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab (RTX) (or its biosimilar).
MOGAD
ROCHE METEROID
The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period.
ACTIVE (NOT RECRUITING) TRIALS
Relapsing Remitting MS
OLERO
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
ENSEMBLE
The purpose of this study is to determine whether ocrelizumab is effective at stopping the signs and symptoms of early stage multiple sclerosis.
The results of this study could help Roche acquire Health Canada approval for ocrelizumab in the future. This would allow ocrelizumab to be used in regular medical practice. The data gathered during the study may also be useful for medical professionals and researchers in the future.
For this study, at least 1000 male and female participants will be recruited at 228 sites globally. The participants will be between 18 and 55 years old.
PASS
A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis
The purpose of this study is to collect information for a period of 10years after your first dose of LEMTRADA, which will include information about your disease, related treatment history, and information to help to obtain a good understanding of potential side effects after treatment with LEMTRADA.
MAGNIFY
The purpose of this study is mainly to look at onset of action of Mavenclad® in the treatment of MS. This means we want to look at how quickly it starts working. The study will also look at the effectiveness of Mavenclad®, how it affects your immune system, and how safe it is (i.e., if there are any side effects)..
For this study, 300 male and female participants will be recruited at approximately 100 sites across Europe (including, but not limited to Austria, Denmark, Finland, France, Germany, Italy, Norway, The Netherlands, Spain, Sweden, Belgium, Czech Republic, Switzerland, the United Kingdom), as well as Israel, Australia and Canada. The participants will be aged 18 years and over.
ALITHIOS
This research study will try to answer to the following questions:
· How well does ofatumumab work in reducing relapses, disease worsening, and brain lesions seen on magnetic resonance imaging (MRI) compared to teriflunomide?
· How safe is treatment with ofatumumab, and how well is ofatumumab tolerated?
· How does ofatumumab affect the body?
· Is there a way to predict how ofatumumab will help in the course of MS from results of special laboratory tests and MRI scans?
NOVA
The purpose of this study is to test how well the study drug works when given every 6 weeks, compared with the standard 4 weeks (which is currently recommended in adults with RRMS). The study will also look at other things, including:
How safe the study drug is.
What your body does to the study drug (“pharmacokinetics”, or PK).
How the study drug affects your body (“pharmacodynamics”, or PD).
How your body’s immune system reacts to the study drug ‒ some subjects may produce antibodies against the study drug (called “antidrug antibodies”, or ADAs). This will need to be checked repeatedly.
How you are responding to the study drug, by looking at biomarkers (substances in the blood).
Any change in your biology related to the John Cunningham (JC) virus.
TOP
Tysabri® Observational Program
TOP is an epidemiological observational study of participants receiving natalizumab, with each participant to be followed for up to 15 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use, and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases.
Primary Progressive MS
OLERO
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
GAVOTTE
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab.
Secondary Progressive MS
EXPAND
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability, and efficacy (Extension Part).
HERCULES
Primary Objective:
To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS
Secondary Objective:
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 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
PATIENTS
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MS TEAM
Dr. Alexander Saveriano
Principal Investigator, MS Trials
Dr. Paul Giacomini
Principal Investigator, MS Trials
James Sirhan
Clinical Research Coordinator
Dylan Sembinelli
Clinical Research Coordinator
CLINICIANS
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Dr. Myriam Lévesque-Roy
Principal Investigator, MS Trials
Luca Pietrantonio
Team Lead, Sr. Clinical Research Coordinator
Pascale Patenaude
Clinical Research Coordinator