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Extension Study Evaluating The Safety And Tolerability of AMX0035

NCT05619783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-01-13

No results posted yet for this study

Summary

The primary objective is to evaluate the safety and tolerability of AMX0035 over 108 weeks of open label treatment for participants previously enrolled in Study A35-004 (PHOENIX).

Conditions

Interventions

DRUG

AMX0035

Combination of 3 g phenylbutyrate and 1 g taurursodiol

Sponsors & Collaborators

  • Amylyx Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Lahar Mehta, MD · Head, Global Clinical Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2024-10-16
Completion
2024-10-30
FDA Drug
Yes

Countries

  • 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 NCT05619783 on ClinicalTrials.gov