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HEALEY ALS Platform Trial - Regimen C CNM-Au8

NCT04414345 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2023-07-25

Study results available
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Summary

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Regimen C will evaluate the safety and efficacy of a single study drug, CNM-Au8, in participants with ALS.

Conditions

Interventions

DRUG

CNM-Au8

Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily

DRUG

Matching Placebo

Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily

Sponsors & Collaborators

  • Clene Nanomedicine

    collaborator INDUSTRY

  • Merit E. Cudkowicz, MD

    lead OTHER

Principal Investigators

  • Merit Cudkowicz · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2022-04-13
Completion
2023-03-07
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 NCT04414345 on ClinicalTrials.gov