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NCT06285643 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Parkinson Disease, sponsored by AskBio.

Recruiting
Registry status
Phase 2
Development phase
127
Enrollment target
20
Study locations

NCT06285643 is a Phase 2 study of Parkinson Disease that is actively recruiting participants, run by AskBio. The registered enrollment target is 127 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT06285643, a Phase 2 study of Parkinson Disease, is actively recruiting participants, sponsored by AskBio.

RECRUITING
Registry status
Phase 2
Development phase
127 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG AAV2-GDNF gene therapy
  • PROCEDURE control surgery

Study Locations (20)

California

  • UCI Alpha Clinic (Neurology) - Irvine
  • Loma Linda University (Neurology) - Loma Linda
  • Loma Linda University (Surgical) - Loma Linda
  • University of California San Francisco (Neurology) - San Francisco
  • University of San Francisco (Surgical) - San Francisco

North Carolina

  • University of North Carolina (Neurology) - Chapel Hill
  • Duke Neurosurgery (Surgical) - Durham
  • Duke University (Neurology) - Durham

Florida

  • Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology) - Boca Raton
  • Parkinson's Disease Treatment Center of Southwest Florida (Neurology) - Port Charlotte

Massachusetts

  • Massachusetts General Hospital (Neurology) - Boston
  • Massachusetts General Hospital (Surgical) - Boston

Michigan

  • Michigan State University (Neurology) - East Lansing
  • Quest Research Institute (Neurology) - Farmington Hills

Colorado

  • CenExel Rocky Mountain Clinical Research (Neurology) - Englewood

District of Columbia

  • Georgetown University (Neurology) - Washington D.C.

Georgia

  • Emory University (Surgical) - Atlanta

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2024-06-11
Est. Completion 2028-08-31
Phase Phase 2

Sponsor

AskBio

8 total trials

What the Registry Record Tells You About NCT06285643

The ClinicalTrials.gov registry entry for NCT06285643 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The listed sponsor is AskBio, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which AAV2-GDNF gene therapy is the first listed.

NCT06285643 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, North Carolina, Florida.

Frequently Asked Questions

What is clinical trial NCT06285643 about?

NCT06285643 is a clinical study titled "A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)". 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.

What is the current status of trial NCT06285643?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2024-06-11. Estimated completion is 2028-08-31.

What conditions does trial NCT06285643 study?

This clinical trial studies the following conditions: Parkinson Disease.

What interventions are being tested in trial NCT06285643?

The interventions under investigation include: AAV2-GDNF gene therapy (DRUG), control surgery (PROCEDURE).

Who is sponsoring clinical trial NCT06285643?

This trial is sponsored by AskBio, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06285643 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.