Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT05257005
Eligibility Criteria:
Inclusion Criteria:
1. Compatible clinical history AND
2a Enzymatic confirmation demonstrating reduced PDH activity in patient cells or muscle tissue OR
2b Confirmed pathogenic mutation in a gene associated with primary PDH deficiency (PDHA1, PDHB, PDHX, PDP1, DLAT) OR
2c First degree relative with a confirmed pathogenic mutation causing primary PDH deficiency
Exclusion Criteria:
Patients with 'secondary PDH deficiency' that is patients who meet criteria 1 and 2a but who have received a genetic diagnosis which confirms pathogenic variants in a gene not associated with primary PDH deficiency.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05257005
Study Brief:
Protocol Section:
NCT05257005