A Study of SmartFlow Magnetic Resonance (MR) Compatible Ventricular Cannula for Administering Eladocagene Exuparvovec to Pediatric Participants
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
13actual
Sites
6
Countries
Israel, Taiwan, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-05-12 | actual | When the study began enrolling |
| Primary completion | 2023-05-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2021-05-26 | actual | When this record first appeared on the registry |
| Results posted | 2025-01-01 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-04-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- AADC Deficiency
Intervention
- Genetic: Eladocagene Exuparvovec — also filed as KEBILIDI™
Primary outcomes
what the primary-completion date above is the date OFChange From Baseline in HVA Metabolite Level at the End of the Trial Phase
measured Baseline (Day 1), Week 8
Number of Participants With Adverse Events (AEs) Associated With the Surgical Administration of Eladocagene Exuparvovec Using the SmartFlow® MR-Compatible Ventricular Cannula
measured Baseline (Day 1) up to Week 8
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-09-01 · 14.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-01-24 · 457 KB · SAP_001.pdf
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