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NCT04220021 · ClinicalTrials.gov registry record · Phase 2
Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD
A Phase 2 study of Frontotemporal Dementia and C9orf72 Amyotrophic Lateral Sclerosis (ALS), sponsored by University of Florida.
- Active
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT04220021: Active Phase 2 study of Frontotemporal Dementia and C9orf72 Amyotrophic Lateral Sclerosis (ALS), sponsored by University of Florida.
NCT04220021 is a Phase 2 study of Frontotemporal Dementia and C9orf72 Amyotrophic Lateral Sclerosis (ALS) that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 41 participants, below the 1,196-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04220021, a Phase 2 study of Frontotemporal Dementia and C9orf72 Amyotrophic Lateral Sclerosis (ALS), is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The safety and tolerability of Metformin in participants with C9orf72 ALS currently treated with Metformin will be evaluated by the number of subjects with treatment-emergent adverse events
Conditions Studied
Interventions
- DRUG Metformin
Study Locations (1)
Florida
- UF Health at the University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2020-01-10 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04220021 still lists
NCT04220021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,196-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Frontotemporal Dementia appearing as the primary indexed condition, and to 1 intervention - of which Metformin is the first listed.
NCT04220021 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04220021 about?
NCT04220021 is a clinical study titled "Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD". 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-AL...
What is the current status of trial NCT04220021?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2020-01-10. Estimated completion is 2026-06-30.
What conditions does trial NCT04220021 study?
This clinical trial studies the following conditions: Frontotemporal Dementia, C9orf72 Amyotrophic Lateral Sclerosis (ALS).
What interventions are being tested in trial NCT04220021?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT04220021?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04220021 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Frontotemporal Dementia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04220021's enrollment target sits among peer trials
41 19th of 22 higher than 4 of 22 other Frontotemporal Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Frontotemporal Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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