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Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment

NCT05021536 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2024-08-14

No results posted yet for this study

Summary

The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for treatment of ALS

Conditions

Interventions

OTHER

Placebo

Matching Placebo Comparator

DRUG

AMX0035

Proprietary formulation of taurursodiol and sodium phenylbutyrate

Sponsors & Collaborators

  • Amylyx Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Amylyx Study Director · Amylyx Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2024-01-19
Completion
2026-01-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

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 NCT05021536 on ClinicalTrials.gov