CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
L-Citrullinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03952234
NCT03952234Phase 1Completed
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Phase-1, Dose Finding and Safety Study on L- Citrulline Treatment of Nitric Oxide Deficiency in MELAS

Baylor College of Medicine·interventional·Posted May 16, 2019·Updated Jun 26, 2024

In Brief

A Phase 1 clinical trial evaluating L-Citrulline for MELAS Syndrome. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMELAS Syndrome
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS), University of South Florida, Columbia University

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMay 16, 2019
Enrollment StartApr 22, 2021
Primary CompletionApr 30, 2024
Study CompletionJun 1, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.1 years ago

Interventions

L-Citrullinedrug

To determine the safest maximum dose of L-Citrulline which could be used as a potential treatment for adults with disorder of energy metabolism called MELAS