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Open Label Extension Study of AMX0035 in Patients With ALS

NCT03488524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-13

Study results available
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Summary

This extension study, in which all participants received active treatment (AMX0035), was designed to assess the longer-term safety and therapeutic potential of AMX0035 for participants who have completed the Main Study (AMX3500, also known as CENTAUR).

Conditions

Interventions

DRUG

AMX0035

Combination therapy of PB and TURSO

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Amylyx Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Sabrina Paganoni, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2021-03-01
Completion
2021-03-01
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 NCT03488524 on ClinicalTrials.gov