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AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT03127514 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2024-05-16

Study results available
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Summary

The CENTAUR trial was a 2:1 (active:placebo) randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.

Conditions

Interventions

DRUG

AMX0035

AMX0035

OTHER

Placebo

Matching Placebo Comparator

Sponsors & Collaborators

  • ALS Finding a Cure

    collaborator OTHER

  • ALS Association

    collaborator OTHER

  • Northeast ALS Consortium

    collaborator OTHER

  • Neurological Clinical Research Institute at Massachusetts General Hospital

    collaborator OTHER

  • Leandro P. Rizzuto Foundation

    collaborator OTHER

  • Amylyx Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Yeramian, MD · Amylyx Pharmaceuticals Inc.

  • Sabrina Paganoni, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2019-09-25
Completion
2019-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127514 on ClinicalTrials.gov