CURRENT RECRUITING TRIALS

CONTACT US
(514) 398-5500 or  ms-cru.neuro@mcgill.ca.

Relapsing Remitting MS

BMS BALANCE

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity (MSS)

A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1). The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

 

NOVARTIS ELIOS

ELIOS – Investigational Biomarkers to Track Disease Modification in Active RRMS (ELIOS)

The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab).

To that end, the study will use the patented investigational, Eye Tracking Neurological Assessment (ETNA-ProgMS) SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision.

ROCHE BRAIN SHUTTLE

A Phase I Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, And Pharmacodynamics of RO7121932 Following Intravenous Administration in Patients with Multiple Sclerosis  

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

BMS BALANCE

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity (MSS)

A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1). The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

ROCHE BRAIN SHUTTLE

A Phase I Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, And Pharmacodynamics of RO7121932 Following Intravenous Administration in Patients with Multiple Sclerosis  

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. 

Secondary Progressive MS

BMS BALANCE

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity (MSS)

A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1). The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

ROCHE BRAIN SHUTTLE

A Phase I Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, And Pharmacodynamics of RO7121932 Following Intravenous Administration in Patients with Multiple Sclerosis  

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. 

NOVARTIS REMASTER 

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis 

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo.

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS). The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.

UPCOMING TRIALS

Relapsing Remitting MS

MODERNA mRNA-1195-P201 

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Early Multiple Sclerosis. The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195.
Primary Progressive MS

MODERNA mRNA-1195-P201 

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Early Multiple Sclerosis. The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195.

VOT

Secondary Progressive MS

MODERNA mRNA-1195-P201 

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Early Multiple Sclerosis. The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195.
CIS (Clinically Isolated Syndrome) / RIS (Radiologically Isolated Syndrome)

MODERNA mRNA-1195-P201 

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Early Multiple Sclerosis. The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195.

ACTIVE (NOT RECRUITING) TRIALS

Relapsing Remitting MS

ALITHIOS

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis

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

A Phase III Multicenter, Randomized, DoubleBlind, DoubleDummy, ParallelGroup Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis

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.

 

SANOFI 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 10 years 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.

 

SANOFI LTS17043

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).

Primary Progressive MS

CALLIPER IMMUNIC-AG

Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis 

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.

 

 

Secondary Progressive MS

CALLIPER IMMUNIC-AG

Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis 

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.

 

SANOFI LTS17043

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).

 

MS TEAM

Dr. Adil Harroud

Dr. Adil Harroud

Principal Investigator

Dr. A. Saveriano

Dr. A. Saveriano

Principal Investigator

Sophie Morris

Sophie Morris

Team Lead

Polina Plitchenko

Polina Plitchenko

Clinical Research Coordinator

Dr. Simon Thebault

Dr. Simon Thebault

Principal Investigator

Dr. Paul Giacomini

Dr. Paul Giacomini

Principal Investigator

Priya Patel

Priya Patel

Clinical research coor

Kyra Schweers

Kyra Schweers

Clinical research coordinator