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Amyotrophic Lateral Sclerosis (ALS)

A Phase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Intravenous ANX005 in Subjects with Amyotrophic Lateral Sclerosis

The purpose of this study is to find out if the investigational drug ANX005 is well tolerated and safe in subjects with ALS when given on Day 1, Day 5 or 6 and then every 2 weeks on Week 2, 4, 6, 8 and 10. Another purpose of this study is to find out more about the investigational drug.

• Website: NCT04248465
• Sponsor: Alexion
• Location: Stan Cassidy Centre for Rehabilitation
• Horizon Principal Investigator: Dr. Colleen O'Connell
• To participate, call the research coordinator at: 506-471-9924  and refer to study file #100773

CHAMPION-ALS (MN-166-ALS-2301): A phase 3, double-blind, randomized, placebo-controlled, parallel-group, multicenter study with an open-label extension to evaluate the efficacy and safety of Ravulizumab with Amyotrophic Lateral Sclerosis (ALS)

This study looks at an investigational drug called ravulizumab. This drug is being developed to treat ALS by blocking complement activity. The complement system is part of your immune system which fights against infections. In patients with ALS, abnormal complement activity is present, which may cause damage to the structures in the body that are responsible for neuromuscular transmission. Ravulizumab is an experimental drug, not approved for ALS. The purpose of this study is to evaluate the safety and efficacy of ravulizumab given intravenously (IV; in the vein) in adult patients with ALS.

• Website: NCT04248465
• Sponsor: Alexion
• Location: Stan Cassidy Centre for Rehabilitation
• Horizon Principal Investigator: Dr. Colleen O'Connell
• To participate, call the research coordinator at: 506-471-9924  and refer to study file #100773

PIMOZIDE2 ALS-002: A Phase II Randomized, Placebo-Controlled, Double-Blinded, Multi-Center Clinical Trial of Pimozide in Patients with Amyotrophic Lateral Sclerosis

This study will look at whether Pimozide may help to slow the progression of Amyotrophic Lateral Sclerosis. 100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo. Participants will be on study medication up to 22 weeks, and on study up to 26 weeks. There are 8 clinic visits and 1 phone visit over the course of the Treatment Phase of the study. The second phase which is Observational, is optional with follow-up for up to 5 years from the end of the Treatment Phase.

• Website: NCT03272503
• Sponsor: University of Calgary
• Location: Stan Cassidy Centre for Rehabilitation
• Horizon Principal Investigator: Dr. Colleen O'Connell
• To participate, call the research coordinator at: 506-471-9924 and refer to study file #10212

CY 5031: A phase 3, multi-center, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS)

Reldesemtiv is being investigated as a potential new therapy for the improvement of skeletal muscle function in conditions associated with muscle weakness or fatigue such as Amyotrophic Lateral Sclerosis ("ALS"). The main purpose of this research study is to evaluate the efficacy and safety of Reldesemtiv.

• Website: NCT03272503
• Sponsor: Cytokinetics
• Location: Stan Cassidy Centre for Rehabilitation
• Horizon Principal Investigator: Dr. Colleen O'Connell
• To participate, call the research coordinator at: 506-471-9924 and refer to study file #101075

A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

The main purpose of this research study is to test whether an experimental drug called edaravone, is effective as treatment against ALS, and if it is safe and well tolerated when given to patients with your illness.

• Website: NCT04569084
• Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.
• Location: Stan Cassidy Centre for Rehabilitation
• Horizon Principal Investigator: Dr. Colleen O'Connell
• To participate, call the research coordinator at: 506-471-9924 and refer to study file #101197

M20-405: A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of ABBV-CLS-7262 in Subjects with Amyotrophic Lateral Sclerosis Followed by an Active Treatment Extension

The main purpose of this study is to investigate the safety, tolerability, (whether side effects of a medication, if they occur, can be handled by subjects), and pharmacokinetics (how a medication is absorbed by and cleared from the body) of multiple doses of ABBV- CLS- 7262 compared to a placebo, for the treatment of ALS. The study also aims to assess how ABBV- CLS¬-7262 affects your body andALS when taken, by measuring and looking at certain markers

• Sponsor: Calico Life Sciences LLC
• Location: Stan Cassidy Centre for Rehabilitation
• Horizon Principal Investigator: Dr. Colleen O'Connell
• To participate, call the research coordinator at: 506-471-9924  and refer to study file #101243