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A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT04516096 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-04-07

No results posted yet for this study

Summary

The protocol is intended to provide extended treatment with AMX0035 to patients who previously participated in an Amylyx sponsored study of AMX0035 for ALS.

Conditions

Interventions

DRUG

AMX0035

Tauroursodeoxycholic Acid and Sodium Phenylbutyrate orally given twice a day

Sponsors & Collaborators

  • Amylyx Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Machelle Manual, PhD · Amylyx Pharmaceuticals Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-22
Primary Completion
2022-12-30
Completion
2023-01-31
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 NCT04516096 on ClinicalTrials.gov