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Clinical Trials/NCT05848271
NCT05848271
Recruiting
Not Applicable

A Patient Registry and Natural History Study of Patients with Biallelic HPDL Mutations

University of California, San Diego1 site in 1 country50 target enrollmentMay 18, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitochondrial Encephalomyopathies
Sponsor
University of California, San Diego
Enrollment
50
Locations
1
Primary Endpoint
Clinician questionnaire
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study uses medical records that allow retrospective data extraction of clinical manifestation to assess the natural history of HPDL mutations

Detailed Description

A novel mitochondrial disease arises from mutations in HPDL, which codes for 4-hydroxyphenylpyruvate dioxygenase-like protein. The main purpose of this study is to establish a patient registry to gather medical data from consenting HPDL mutation patients worldwide. From longitudinal data, we will be able to figure out the natural history of the disease, and genotype-phenotype correlation. Dry blood spots will be collected to develop biomarkers to understand the disease better.

Registry
clinicaltrials.gov
Start Date
May 18, 2023
End Date
December 31, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Gleeson

professor, neuroscience

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • Any individuals diagnosed with HPDL variants
  • Clinical diagnosis can include:
  • HPDL-related hereditary spastic paraplegia (HSP)
  • HPDL-related neonatal mitochondrial encephalopathy
  • Spastic paraplegia -83 (SPG83)
  • Neurodevelopmental disorder with progressive spasticity and brain white matter abnormalities (NEDSWMA)

Exclusion Criteria

  • Any known genetic abnormality (other than HPDL mutation)
  • Any condition that, in the opinion of the Site Investigator, could put the participant at undue risk and/or would ultimately prevent the completion of study procedures

Outcomes

Primary Outcomes

Clinician questionnaire

Time Frame: 12 months

Clinician-reported clinical and genetic confirmation of HPDL mutations

Study Sites (1)

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