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A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)

Study acronym: REGENERATE-PD
StatusActive, Not Recruiting
PhasePhase 2
SponsorAskBio Inc
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Eligibility criteria expanded, about 18 words · Site details revised at 46 of 46 sites Show 2 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Site details revised at 46 of 46 sites
  2. Study sites: 39 to 46v35
  3. Primary and study completion dates: Nov 30, 2027 to Aug 31, 2028 Enrollment target: 87 to 127 · Interventions: AAV2-GDNF Gene therapy (Drug), Control Surgery (Procedure) to AAV2-GDNF gene therapy (Drug), control surgery (Procedure) · Eligibility criteria revisedv34 Show 3 more changesShow less
    • Enrollment target: 87 to 127
    • Interventions: AAV2-GDNF Gene therapy (Drug), Control Surgery (Procedure) to AAV2-GDNF gene therapy (Drug), control surgery (Procedure)
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv33
  5. Site details revised at 7 of 39 sitesv32
Show 30 earlier versionsHide 30 earlier versions
  1. Site details revised at 2 of 39 sitesv31
  2. Site details revised at 1 of 39 sitesv30
  3. Site details revised at 2 of 39 sitesv29
  4. Site details revised at 3 of 39 sitesv28
  5. Site contacts updated at 2 of 39 sitesv27
  6. Site details revised at 2 of 39 sitesv26
  7. Site contacts updated at 1 of 39 sitesv25
  8. Site details revised at 3 of 39 sitesv24
  9. Study sites: 37 to 39v23
  10. Study sites: 33 to 37v22
  11. Study sites: 32 to 33v21
  12. Study sites: 30 to 32v20
  13. Study sites: 28 to 30v19
  14. Study sites: 26 to 28v18
  15. Site details revised at 4 of 26 sitesv17
  16. Study Status, Referencesv16
  17. Site details revised at 1 of 26 sitesv15
  18. Study sites: 23 to 26v14
  19. Study sites: 18 to 23v13
  20. Site details revised at 2 of 18 sitesv12
  21. Site details revised at 1 of 18 sitesv11
  22. Study sites: 17 to 18v10
  23. Study sites: 9 to 17v9
  24. Site details revised at 2 of 9 sitesv8
  25. Study sites: 7 to 9v7
  26. Site details revised at 2 of 7 sitesv6
  27. Site details revised at 1 of 7 sitesv5
  28. Site details revised at 1 of 7 sitesv4
  29. Re-verified, no change to tracked fieldsv3
  30. Trial status: Not Yet Recruiting to Recruiting Primary endpoints: 3 to 1 · Study sites: 0 to 7 · Start date changed from estimate of Apr 1, 2024 to Jun 11, 2024 · 2 morev2 Show 5 more changesShow less
    • Primary endpoints: 3 to 1
    • Study sites: 0 to 7
    • Start date changed from estimate of Apr 1, 2024 to Jun 11, 2024
    • Eligibility criteria shortened, about 89 words
    • Secondary endpoints shortened, about 31 words

    See this version in full on ClinicalTrials.gov ↗

  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.
AskBio Inc
9 trials monitored
See 3 trials at risk
Parkinson's Disease
1,435 trials monitored
See 62 trials at risk
The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.
Trial Details
NCT Number NCT06285643
Lead Sponsor AskBio Inc
Collaborators: Bayer
Conditions Parkinson Disease
Enrollment 127 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov