Open Label Extension Study of AMX0035 in Patients With ALS (CENTAUR-OLE)
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the Centaur study.
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Drug Trial
Study Chair(s)/Principal Investigator(s):
Clinicaltrials.gov ID (11 digit #):NCT03488524
Coordinating Center Contact InformationMassachusetts General Hospital
Full Study Summary:
The Centaur Open Label Extension Study (CENTAUR-OLE) is designed to provide longer term access to AMX0035 for patients with ALS who participated in the CENTAUR study. The study will assess longer term safety and therapeutic potential of AMX0035.
Study Sponsor:Amylyx Pharmaceuticals Inc.
Estimated Study Start Date:03/29/2018
Estimated Study Completion Date:01/01/2020
Posting Last Modified Date:05/02/2019
Date Study Added to alsconsortium.org:04/10/2018
Time since Symptom Onset:
Time since Diagnosis:
Can participants use Riluzole?Yes
Completion of all visits in the randomized, double blind AMX0035 study. Subjects that receive tracheostomy or PAV during the course of the main study will still be followed as ITT until the week 24 visit before enrollment in the OLE.
Must enroll in the OLE within 28 days of the Week 24 visit of the main study.
Signed informed consent to enter the open label extension phase.
Discontinued study drug prematurely in the double-blind phase of the study for reasons other than tracheostomy or PAV.
Exposure to or anticipated requirement for any disallowed medication listed below.
Any ongoing adverse events that in the opinion of the Site Investigator are clear contraindications to the study drug.
Unstable cardiac or other life-threatening disease emergent during the randomized, double blind study
Any major medical condition that in the opinion of the Site Investigator would interfere with the study and place the subject at increased risk.
- Site Contact Information