Open Label Extension Study of AMX0035 in Patients With ALS

Open Label Extension Study of AMX0035 in Patients With ALS

Quick Info:

Status:
Enrolling by invitation
Estimated Enrollment:
132
Phase:
2
Treatment Type:
Drug: AMX0035
Trial Type:
This an open-label extension study to CENTAUR (AMX-3500), open label, single group assignment
Sponsor:
Amylyx Pharmaceuticals Inc.
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
N/A
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
N/A
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
N/A
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
N/A
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

6/5/2018Changed Emily's email address to Partners v HMS
4/20/2018Location updated
4/9/2018Trial added

Locations:

Massachusetts General Hospital , Boston, 02114
University of Massachusetts Memorial Medical Cente, Worcester, 01655

Other Information:

Purpose: This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the Centaur study.
Eligibility: All ages, all genders, not accepting healthy volunteers
Details: 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.
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 3/23/2018
ClinicalTrials.gov ID: NCT03488524
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov