An interventional study of Glutamine oral supplement in MELAS Syndrome, sponsored by Hospital Universitario 12 de Octubre. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Hospital Universitario 12 de Octubre · Not applicable, Interventional, and Treatment
The purpose of this study is to assesses the clinical efficacy of oral supplementation with glutamine over 3 years.
Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) syndrome is a genetically heterogeneous disorder. The most common mutation is in the mtDNA gene MT-TL1 encoding the mitochondrial tRNALeu (UUR). For understanding the development of seizures in patients with mitochondrial disease, a study has recently emphasized the deficiency of astrocytic glutamine synthetase, creating a disinhibited neuronal network for seizure generation. The investigators propose to evaluate nine patients with mitochondrial DNA mutation and MELAS. Patients will receive oral supplementation with 12-18 g/day of glutamine (adjusted for weight and plasma concentrations). The primary outcome measures modification in clinical scales.
30 studies on the registry are indexed under MELAS Syndrome; 8 are open to participants now.
This study's enrollment of 9 is below the median of 27 across 24 interventional studies indexed under MELAS Syndrome.
Browse MELAS Syndrome studies →Hospital Universitario 12 de Octubre is the lead sponsor of 33 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with MELAS syndrome will receive 12-18g/day of glutamine
Dietary Supplement: Glutamine oral supplement
12-18 g /day of glutamine supplementation
Clinical efficacy; JMDRS
Change from Baseline clinical scale (Japanese mitochondrial disease rating scale (JMDRS)) at 12,24,36 months to test Clinical efficacy of oral supplementation
Time frame: 36 months
Clinical efficacy; MMSE
Change from Baseline cognitive test (Mini-Mental State Examination (MMSE)) at 12,24,36 months to test Clinical efficacy of oral supplementation
Time frame: 36 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To recorde all adverse events grades; with special interest on investigations (CTCAE v5.0, 2017)
Time frame: 36 months
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Hospital Universitario 12 de Octubre