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NCT04220021 · ClinicalTrials.gov record · last posted 2026-08-20

Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD

Name: Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD — clinical trial record (NCT04220021)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhasePhase 2

SponsorUniversity of Florida

Started2020-01-10

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

The primary objective is to assess the safety and tolerability of Metformin in subjects with C9orf72 amyotrophic lateral sclerosis administered for 24 weeks. The overall objective is to determine if Metformin is safe in C9orf72 ALS patients and is a potentially viable therapeutic treatment for C9-ALS that reduces repeat-associated non-canonical start codon - in DNA (non-ATG) (RAN) proteins that are produced by the C9orf72 repeat expansion mutation.

Protocol amendment history 1 change detected by DataLookout

2026-08-21

Completion pushed: 2026-06-30 → 2027-08-31

Trial Details

NCT Number	NCT04220021
Lead Sponsor	University of Florida Collaborators: ALS Association, United States Department of Defense
Conditions	C9orf72 Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Dementia
Enrollment	41 participants
Start Date	2020-01-10
Primary Completion	2024-08-26 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-20