Study Purpose:
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the Centaur study.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis , ALS
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
AMX0035
Placebo:
No
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Massachusetts General Hospital
Boston, Massachusetts, 02114 United States
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 Enrollment:
95
Estimated Study Start Date:
03 / 29 / 2018
Estimated Study Completion Date:
11 / 01 / 2021
Posting Last Modified Date:
01 / 10 / 2022
Date Study Added to neals.org:
04 / 05 / 2018
Minimum Age:
N/A
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Inclusion Criteria:1. 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.
2. Must enroll in the OLE within 28 days of the Week 24 visit of the main study.
3. Signed informed consent to enter the open label extension phase.
Exclusion Criteria:
1. Discontinued study drug prematurely in the double-blind phase of the study for reasons other than tracheostomy or PAV.
2. Exposure to or anticipated requirement for any disallowed medication listed below.
3. Any ongoing adverse events that in the opinion of the Site Investigator are clear contraindications to the study drug.
4. Unstable cardiac or other life-threatening disease emergent during the randomized, double blind study
5. Any major medical condition that in the opinion of the Site Investigator would interfere with the study and place the subject at increased risk.
Massachusetts General Hospital
Boston, Massachusetts
02114
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts
01655
United States