GooGhywoiu9839t543j0s7543uw1 - add alsalberta@gmail.com to GA account 66309507 with "Administrator" permissions - date 10/07/2022
 

Clinical Trials 

 

Clinical trials are research studies that use human volunteers to test new therapies. After scientists test experimental therapies in the laboratory, those with promising results move to clinical trial to determine whether the therapy is safe and effective for use in humans. A new therapy must successfully pass through a series of phases before ultimately being approved by Health Canada and being made widely available to the Canadian public (learn more in our Clinical Trials FAQs).

In general, ALS clinical trials are therapeutic or observational in nature. Therapeutic clinical trials test potential drug therapies or interventional devices that aim to either slow the progression of the disease or help to manage symptoms. Observational trials aim to learn more about the disease and are essential to understanding, diagnosing and ultimately treating ALS. In many cases people who participate in clinical trials will not benefit from the therapy, but their generous involvement will help to find a successful therapy for those diagnosed in the future. One day, a clinical trial will test a therapeutic that slows the progression of ALS and those involved may directly benefit from taking part.

For more information, please speak with your clinician (preferably at an ALS clinic) and visit ClinicalTrials.gov, where all legitimate, recognized ALS clinical trials are registered globally. You can also visit the EU Clinical Trials Register and the World Health Organization International Clinical Trials Registry for additional information.

You can learn more about the clinical trials currently being conducted in Alberta below:

 

University of Alberta Updates: September 2022

Study of ANX005 in Adults with Amyotrophic Lateral Sclerosis (ALS)

A multi-center, open-label study of intravenous administration of ANX005 in patients with ALS.

Study Type: Therapeutic, Phase 2a

Status: Active & Recruiting

A Study to Evaluate Safety, Tolerability, Pharmacodynamic (PD) Markers, and Pharmacokinetics (PK) of AP-101 in Participants with Amyotrophic Lateral Sclerosis (ALS)

A multi-center, randomized, double-blind, and placebo-controlled study to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with familial and sporadic ALS.

Study Type: Therapeutic, Phase 2a

Status: Active & Recruiting

A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) (COURAGE-ALS)

A multi-center, randomized, double-blind, and placebo-controlled trial of reldesemtiv to assess the effects on functional outcomes in patients with ALS.

Study Type: Therapeutic, Phase 3

Status: Active & Recruiting

Efficacy and Safety Study of Oral Edaravone Administered in Subjects with ALS

A multi-center, randomized, double-blind and placebo-controlled study to evaluate efficacy and safety of oral edaravone in subjects with ALS.

Study Type: Therapeutic, Phase 3

Status: Active & Recruiting

A Study to Investigate the Safety and Pharmacokinetics (PK) of ABBV-CLS-7262 in Patients with Amyotrophic Lateral Sclerosis

A multi-center, randomized, double-blind, and placebo-controlled study to assess safety, tolerability, and PK in patients with ALS following multiple doses of oral ABBV-CLS-7262 and an active treatment extension.

Study Type: Therapeutic, Phase 1

Status: Active & Recruiting

Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-Label Extension for 6 Months in Patients with ALS

A multi-center, randomized, double-blind, and placebo-controlled 12 month clinical trial followed by an open-label extension phase to evaluate the efficacy and safety of MN-166 in patients with ALS.

Study Type: Therapeutic, Phase 2b/3

Status: Active & Recruiting


For more information on the ongoing ALS projects at the University of Alberta visit https://sites.google.com/a/ualberta.ca/als-clinical-research/


 

University of Calgary Research Updates

 Updated September 2022

The CNDR is actively recruiting individuals with ALS who are using or have used edaravone or albrioza. Currently, the CNDR is collaborating with clinicians, scientists, patient organizations, and industry on important studies to evaluate the safety, tolerability, and effectiveness of ALS therapies to support access to drugs for Canadians who may benefit. 

The Canadian Neuromuscular Disease Registry (CNDR) is a national registry partnering with ALS clinics across the country aiming to improve access to care and therapies for people with ALS, and to increase the impacts of research in the Canadian healthcare system. The CNDR works with the community as valuable partners to provide essential clinical data related to people living with ALS. In order to participate, you will need to sign a form and agree for your physician to provide your medical information to the registry. Your privacy and security are always protected.

To join the CNDR community, please register

here: www.cndr.org

Enrolling Clinical Drug Trial:

A Phase 3, Multi-center, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of reldesemtiv in patient with ALS                                                                                Sponsor: Cytokinetics                                                                                       

Trial Name: COURAGE-ALS

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

Sponsor: Calico Life Sciences

Phase: 1b

 

A Phase 2b/3, Multi-centre, randomized, double-blind, placebo-controlled, 12 month clinical trial to evaluate the efficacy and safety of MN-166 (Ibudilast) followed by an open-label extension in subjects with ALS                                                                                                                  

 Sponsor: Medicinova                                                                                       

Trial Name: COMBAT ALS

 

A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation (ATLAS)

 Sponsor: Biogen MA Inc

Trial Name: ATLAS

 

Staff Contacts:    

Jose Martinez  jamarti@ucalgary.ca       403-210-7009 

Janet Petrillo   japetril@ucalgary.ca       403-210-7006