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

Study Purpose:

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 Status:

Enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT03488524

Neals Affiliated?

No

Coordinating Center Contact Information

Massachusetts General Hospital
Emily Engel / .(JavaScript must be enabled to view this email address) / 617-724-7210
.(JavaScript must be enabled to view this email address) 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.

Participant Duration:

Estimated Enrollment:

132

Estimated Study Start Date:

03/29/2018

Estimated Study Completion Date:

01/01/2020

Posting Last Modified Date:

04/10/2018

Date Study Added to alsconsortium.org:

04/10/2018
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    N/A

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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.

  • Site Contact Information

    Massachusetts General Hospital
    Boston, Massachusetts 02114
    United States