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Allopregnanolone as a Regenerative Treatment for Parkinson's Disease

NCT06263010 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Allopregnanolone

Allopregnanolone is a neurosteroid ( 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one) and by-product of the metabolism of the hormone progesterone.

Sponsors & Collaborators

  • Roberta Brinton

    lead OTHER

Principal Investigators

  • Scott Sherman, MD · University of Arizona

  • Roberta D Brinton, PhD · University of Arizona

  • Gerson D Hernandez, MD, MPH · University of Arizona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2025-07-15
Completion
2025-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06263010 on ClinicalTrials.gov