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A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients

Study acronym: AADC
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Mar 2029 to Aug 31, 2027
    • Study completion pushed from Mar 2037 to Aug 2037
    v19
  2. Primary completion date: Jul 2027 to Mar 2029
    • Study completion date: Jul 2031 to Mar 2037
    v18
  3. Site contacts updated at 1 of 3 sitesv17
  4. Site contacts updated at 1 of 3 sitesv16
  5. Re-verified, no change to tracked fieldsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Start date: Jul 2016 to Jul 1, 2016v14
  2. Re-verified, no change to tracked fieldsv13
  3. Enrollment target: 31 to 42
    • Eligibility criteria expanded, about 20 words
    • Site contacts updated at 3 of 3 sites
    v12
  4. Primary completion date: Jan 2027 to Jul 2027
    • Study completion date: Jan 2030 to Jul 2031
    • Site contacts updated at 1 of 3 sites
    v11
  5. Site details revised at 1 of 3 sitesv10
  6. Primary completion date: Jan 2023 to Jan 2027
    • Study completion date: Jan 2028 to Jan 2030
    • Site contacts updated at 1 of 3 sites
    v9
  7. Trial status: Active, Not Recruiting to Recruitingv8 Show 5 more changesShow less
    • Enrollment target: 7 to 31
    • Primary completion date: Jan 2022 to Jan 2023
    • Study sites: 2 to 3
    • Study completion date: Jan 2024 to Jan 2028
    • Eligibility criteria shortened, about 67 words
  8. Lead sponsor: Krystof Bankiewicz to Krzysztof Bankiewiczv7 Show 7 more changesShow less
    • Primary completion date: Dec 2020 to Jan 2022
    • Primary endpoints revised (2)
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 6 to confirmed 7
    • Study sites: 1 to 2
    • Study completion date: Jun 2021 to Jan 2024
    • Collaborators: 1 to 2
  9. Primary completion date: Dec 2018 to Dec 2020
    • Study completion date: Dec 2020 to Jun 2021
    • Site contact updated
    v6
  10. Re-verified, no change to tracked fieldsv5
  11. Eligibility criteria expanded, about 14 wordsv4
  12. Eligibility criteria shortened, about 104 wordsv3
  13. Primary endpoints revised (2)
    • Secondary endpoints: 4 to 3
    • Eligibility criteria shortened, about 5 words
    • Study description expanded, about 2 words
    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.
The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in children with aromatic L-amino acid decarboxylase (AADC) deficiency.
Trial Details
NCT Number NCT02852213
Lead Sponsor Krzysztof Bankiewicz
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), University of California, San Francisco
Conditions
(from sponsor)		 AADC Deficiency
Related terms Aromatic amino acid decarboxylase deficiency
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov