Natural History Study of MNGIE

Mitochondrial Neurogastrointestinal Encephalomyopathy Clinical Trial

Official title:

Natural History Study of Mitochondrial Neurogastrointestinal Encephalomyopathy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04245917
• Other study ID #: ET-NHS-901
• Status: Suspended
• Start date: August 6, 2020
• Est. completion date: February 2026

Study information

• Verified date: July 2021
• Source: Entrada Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Non-interventional, prospective, multicenter, natural history study of patients with mitochondrial neurogastrointestinal encephalomyopathy (MNGIE)

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Has MNGIE

Exclusion Criteria:

• Substance abuser

Related Conditions & MeSH terms

• Mitochondrial Neurogastrointestinal Encephalomyopathy

Intervention

Other:
• Non-interventional
Non-interventional natural history study

Locations

Country	Name	City	State
Turkey	Gazi Üniversitesi Tip Fakültesi	Ankara
Turkey	Ege University Medical Faculty; Department of Pediatrics	Bornova	Izmir
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Baylor St Luke's Medical Center and Texas Children's Hospital at Baylor College of Medicine	Houston	Texas
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Entrada Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MNGIE Clinical Course	To evaluate the clinical course of MNGIE patients	5 years