CURRENT RECRUITING TRIALS
For more information about recruiting trials, contact the MS Team at ms-cru.neuro@mcgill.ca.
Relapsing Remitting MS
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.
BRAIN SHUTTLE
The purpose of this study is to test the safety of the RO7121932 at different dose levels; determine how well it is tolerated; measure how the body absorbs, distributes, and gets rid of it (this is called “pharmacokinetics” [PK]); and find out what effects RO7121932 has.
RO7121932 combines an antibody with a “brain shuttle” module, which delivers it to the brain. Antibodies act like your body’s immune system and attach themselves to certain cells to attack germs and other illnesses in your body.
The Study Drug attaches to certain types of white blood cells (B cells) and reduces their number. These B cells, especially those in the brain, are thought to play a role in MS.
Primary Progressive MS
BRAIN SHUTTLE
The purpose of this study is to test the safety of the RO7121932 at different dose levels; determine how well it is tolerated; measure how the body absorbs, distributes, and gets rid of it (this is called “pharmacokinetics” [PK]); and find out what effects RO7121932 has.
RO7121932 combines an antibody with a “brain shuttle” module, which delivers it to the brain. Antibodies act like your body’s immune system and attach themselves to certain cells to attack germs and other illnesses in your body.
The Study Drug attaches to certain types of white blood cells (B cells) and reduces their number. These B cells, especially those in the brain, are thought to play a role in MS.
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
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
MOGAD
ROCHE METEOROID
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.
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
To come
ACTIVE (NOT RECRUITING) TRIALS
Relapsing Remitting MS
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?
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.
LIBERTO
A single arm, open label multicentre extension study to evaluate the effectiveness and safety of ocrelizumab in patients with multiple sclerosis previously enrolled in a F. Hoffmann-La Roche sponsored ocrelizumab phase IIIb/IV clinical trial
The purpose of this study is to continue providing treatment with ocrelizumab (study drug) after completion of your participation in the previous ocrelizumab clinical trial (which in opinion of your treating physician is beneficial to you) to see the long-term safety and effectiveness of this drug.
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.
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.
Primary Progressive MS
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.
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
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.
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
MS TEAM
Dr. Alexander Saveriano
Principal Investigator, MS Trials
Dr. Paul Giacomini
Principal Investigator
Michael Pileggi
Clinical Research Coordinator
Dr. Myriam Lévesque-Roy
Principal Investigator, MS Trials
Pascale Patenaude
Team Lead
Eric Han
Clinical Research Coordinator