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A Study of SmartFlow Magnetic Resonance (MR) Compatible Ventricular Cannula for Administering Eladocagene Exuparvovec to Pediatric Participants

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. 12 versions Re-verified since Mar 4, 2025, no change to tracked fieldsv35-v46
  2. Results first posted: Jan 1, 2025
    • Primary endpoints revised (2)
    • Secondary endpoints revised (10)
    v34
  3. 5 versions Re-verified since Jun 17, 2024, no change to tracked fieldsv29-v33
  4. Eligibility criteria revisedv28
  5. Re-verified, no change to tracked fieldsv27
Show 25 earlier versionsHide 25 earlier versions
  1. Enrollment target: 3 to 13v26
  2. Re-verified, no change to tracked fieldsv25
  3. Study title revisedv24
  4. Re-verified, no change to tracked fieldsv23
  5. Study completion date: Feb 28, 2025 to Apr 30, 2028
    • Secondary endpoints revised (10)
    v22
  6. Secondary endpoints: 9 to 10v21
  7. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jul 15, 2023 to May 22, 2023
    • Site details revised at 6 of 6 sites
    v20
  8. Primary endpoints: 1 to 2
    • Secondary endpoints: 1 to 9
    v19
  9. Study completion date: Jul 15, 2023 to Feb 28, 2025v18
  10. 2 versions Re-verified since Mar 10, 2023, no change to tracked fieldsv16-v17
  11. Site details revised at 1 of 6 sitesv15
  12. Eligibility criteria expanded, about 32 words
    • Primary endpoint revised
    • Site details revised at 1 of 6 sites
    v14
  13. Re-verified, no change to tracked fieldsv13
  14. Study sites: 7 to 6v12
  15. 7 versions Re-verified since Feb 18, 2022, no change to tracked fieldsv5-v11
  16. Study sites: 5 to 7v4
  17. Site details revised at 1 of 5 sitesv3
  18. Primary and study completion dates: Jan 4, 2023 to Jul 15, 2023
    • Study sites: 1 to 5
    • Eligibility criteria shortened, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will have a trial phase, extension phase, and a long-term extension phase. The primary objectives of the trial phase are to assess the pharmacodynamics (PD) of eladocagene exuparvovec treatment by evaluation of homovanillic acid (HVA) levels and to assess the safety of the SmartFlow® magnetic resonance (MR) Compatible Ventricular Cannula for administering eladocagene exuparvovec to pediatric participants with aromatic L-amino acid decarboxylase (AADC) deficiency. The extension phase is designed to capture additional clinical information for eladocagene exuparvovec through study evaluations, changes in motor development, AADC-specific symptoms, and other PD measures. The long-term extension phase is designed to capture long-term safety and efficacy data from participants treated with eladocagene exuparvovec.
Trial Details
NCT Number NCT04903288
Lead Sponsor PTC Therapeutics
Conditions
(from sponsor)		 AADC Deficiency
Related terms Aromatic amino acid decarboxylase deficiency
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov