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NCT03488524 · ClinicalTrials.gov registry record · Phase 2

Open Label Extension Study of AMX0035 in Patients With ALS

A Phase 2 study of Amyotrophic Lateral Sclerosis and ALS, sponsored by Amylyx Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
90
Enrollment target
20
Study locations

NCT03488524 is a Phase 2 study of Amyotrophic Lateral Sclerosis and ALS that has completed, run by Amylyx Pharmaceuticals. The registered enrollment target is 90 participants, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT03488524, a Phase 2 study of Amyotrophic Lateral Sclerosis and ALS, has completed, sponsored by Amylyx Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
90 participants
Enrollment target
20
Study locations

Study 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).

Interventions

  • DRUG AMX0035

Study Locations (20)

California

  • University of California, Irvine - Orange
  • California Pacific Medical Center - San Francisco

Florida

  • University of Florida College of Medicine - Gainesville
  • University of South Florida College of Medicine - Tampa

Massachusetts

  • Massachusetts General Hospital - Boston
  • University of Massachusetts Memorial Medical Center - Worcester

Arizona

  • Barrow Neurological Institute-Dignity Health, St Joseph's Hospital and Medical Center - Phoenix

Georgia

  • Emory University Hospital - Atlanta

Iowa

  • University of Iowa, Carver College of Medicine - Iowa City

Kentucky

  • University of Kentucky Medical Center - Lexington

Louisiana

  • Ochsner Neuroscience Institute - New Orleans

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2018-03-29
Est. Completion 2021-03-01
Phase Phase 2

Sponsor

Amylyx Pharmaceuticals

9 total trials

What the Registry Record Tells You About NCT03488524

The ClinicalTrials.gov registry entry for NCT03488524 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (90% lower). The listed sponsor is Amylyx Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which AMX0035 is the first listed.

NCT03488524 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03488524 about?

NCT03488524 is a clinical study titled "Open Label Extension Study of AMX0035 in Patients With ALS". 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).

What is the current status of trial NCT03488524?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2018-03-29. Estimated completion is 2021-03-01.

What conditions does trial NCT03488524 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, ALS.

What interventions are being tested in trial NCT03488524?

The interventions under investigation include: AMX0035 (DRUG).

Who is sponsoring clinical trial NCT03488524?

This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03488524 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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