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NCT06263010: Allo-PD

Allopregnanolone as a Regenerative Treatment for Parkinson's Disease

Completed Phase 1 Last updated 13 March 2026
What this trial tests

Phase 1 trial testing Allopregnanolone in Parkinson Disease in 10 participants. Completed in 15 July 2025.

Timeline
12 January 2024
Primary endpoint
15 July 2025
15 July 2025

Quick facts

Lead sponsorRoberta Brinton
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment10
Start date12 January 2024
Primary completion15 July 2025
Estimated completion15 July 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Roberta Brinton

Who can join

Adults 40 to 85, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are: 1. Is a large-scale clinical trial testing how well it works in patients with PD feasible? 2. Is allopregnanolone safe and well-tolerated in patients with PD. 3. Can we see any signals of changes in imaging and clinical scales? Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Should old acquaintance be forgot: A call for recognition and inclusion of advanced Parkinson's disease patients & care partners in evolving research models.
    Park JS, Pensyl C, Manak TJ, Fleisher JE. · · 2025 · PMID 40645862 · DOI 10.1016/j.parkreldis.2025.107949

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Other trials of Allopregnanolone

Trials testing the same drug.

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Currently open trials in the same condition.

Other Roberta Brinton trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06263010.

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