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NCT03952234 · ClinicalTrials.gov registry record · Phase 1
L-Citrulline Dose Finding Safety Study in MELAS
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03952234: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT03952234 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03952234, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The main purpose of this study is to determine the safest maximum dose of an amino acid, citrulline, which will be used as potential treatment for adult patients with a disorder of energy metabolism called Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS). Once established, this dose will be used in a future clinical trial.
Primary Outcome
Measurement of the incidence of treatment-emergent adverse events in a safety and tolerability phase 1 study. The following Dose Limiting Toxicities (DLTs) will be measured: 1. Treatment-related adverse events (AE) at grade 3 or higher, or worsening of baseline status, defined by increase of at least 2 grades, if baseline grade is ≤1. The AEs will be graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Subjects will be specifically monitored for the occurre
Interventions
- DRUG L-Citrulline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2024-06-01 |
| Phase | Phase 1 |
What the finished NCT03952234 record still lists
NCT03952234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which L-Citrulline is the first listed.
NCT03952234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03952234 about?
NCT03952234 is a clinical study titled "L-Citrulline Dose Finding Safety Study in MELAS". The main purpose of this study is to determine the safest maximum dose of an amino acid, citrulline, which will be used as potential treatment for adult patients with a disorder of energy metabolism called Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS). Once estab...
What is the current status of trial NCT03952234?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-04-22. Estimated completion is 2024-06-01.
What interventions are being tested in trial NCT03952234?
The interventions under investigation include: L-Citrulline (DRUG).
Who is sponsoring clinical trial NCT03952234?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03952234's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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