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NCT04817111 · ClinicalTrials.gov registry record · Phase 2
NAD+ Precursor Supplementation in Friedreich's Ataxia
A Phase 2 study, sponsored by Metro International Biotech.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT04817111: Completed Phase 2 study, sponsored by Metro International Biotech.
NCT04817111 is a Phase 2 study that has completed, run by Metro International Biotech. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04817111, a Phase 2 study, has completed, sponsored by Metro International Biotech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The primary objective is to test the safety and tolerability of short-term therapy with a nicotinamide adenine dinucleotide (NAD+) precursor (MIB-626) in adults with Friedreich's Ataxia (FA) without overt heart failure and with a left ventricular ejection fraction ≥ 40%. A key secondary objective is to test the effects of MIB-626 on cardiac and skeletal muscle bioenergetics.
Primary Outcome
Safety will be monitored through collection of laboratory assessments (CBC, complete metabolic profile, lipid profile, HbA1c), vital signs (heart rate, blood pressure), and ECG, all of which will be reviewed for clinically relevant abnormalities, and standardized assessment of symptoms. We report the proportion of individuals who had at least one treatment-emergent adverse event of Grade 1 or higher.
Interventions
- DRUG MIB-626
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-05-17 |
| Est. Completion | 2022-05-19 |
| Phase | Phase 2 |
What the finished NCT04817111 record still lists
NCT04817111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which MIB-626 is the first listed.
NCT04817111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04817111 about?
NCT04817111 is a clinical study titled "NAD+ Precursor Supplementation in Friedreich's Ataxia". The primary objective is to test the safety and tolerability of short-term therapy with a nicotinamide adenine dinucleotide (NAD+) precursor (MIB-626) in adults with Friedreich's Ataxia (FA) without overt heart failure and with a left ventricular ejection fraction ≥ 40%. A key secondary objective is...
What is the current status of trial NCT04817111?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2021-05-17. Estimated completion is 2022-05-19.
What interventions are being tested in trial NCT04817111?
The interventions under investigation include: MIB-626 (DRUG).
Who is sponsoring clinical trial NCT04817111?
This trial is sponsored by Metro International Biotech, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04817111's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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