Open Label Extension Study of AMX0035 in Patients With ALS (CENTAUR-OLE)

Amylyx Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

ALS

Amyotrophic Lateral Sclerosis

Treatments

Drug: AMX0035

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03488524

AMX-3500-OLE

Details and patient eligibility

About

This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the Centaur study.

Full description

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.

Enrollment

95 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.