NCT05255328

Brief Summary

The purpose of this study is to assesses the clinical efficacy of oral supplementation with glutamine over 3 years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

January 19, 2022

Last Update Submit

September 27, 2023

Conditions

MELAS Syndrome

Keywords

MELASGlutamineOral supplementsAmino acids

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    36 months

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    36 months

Study Arms (1)

MELAS

EXPERIMENTAL

Patients with MELAS syndrome will receive 12-18g/day of glutamine

Dietary Supplement: Glutamine oral supplement

Interventions

Glutamine oral supplementDIETARY_SUPPLEMENT

12-18 g /day of glutamine supplementation

MELAS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MELAS syndrome Clinically and genetically confirmed.
  • Patients have already participated in GLN-9-MIT study

You may not qualify if:

  • subjects harboring a MELAS-related pathogenic mtDNA mutation no fulfilling the complete diagnostic criteria for the MELAS phenotype

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

MELAS Syndrome

Condition Hierarchy (Ancestors)

Mitochondrial EncephalomyopathiesMitochondrial MyopathiesMuscular DiseasesMusculoskeletal DiseasesBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersNeuromuscular DiseasesVascular DiseasesCardiovascular DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Study Officials

  • Jesús González de la Ajeja Tejera, MD, PhD

    Hospital Universitario 12 Octubre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Glutamine oral supplementation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jesús González de la Aleja Tejera, MD, PhD, Principal Investigator

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 24, 2022

Study Start

July 1, 2021

Primary Completion

July 15, 2022

Study Completion

July 24, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

ES(1)