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drugset / Trial / NCT06263010

Allopregnanolone as a Regenerative Treatment for Parkinson's Disease

NCT06263010 ↗

Phase 1 Completed 10 enrolled Roberta Brinton
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-01-12
Primary completion
2025-07-15
Completion
2025-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Allopregnanolone Small molecule 4 mg Intravenous

Indications

Parkinson disease