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NCT06263010: Allo-PD
Allopregnanolone as a Regenerative Treatment for Parkinson's Disease
Phase 1 trial testing Allopregnanolone in Parkinson Disease in 10 participants. Completed in 15 July 2025.
15 July 2025
Quick facts
| Lead sponsor | Roberta Brinton |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 12 January 2024 |
| Primary completion | 15 July 2025 |
| Estimated completion | 15 July 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Allopregnanolone — full drug profile →
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06263010
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Allopregnanolone
Trials testing the same drug.
- NCT04003285 — Allopregnanolone in Chronic Complex Traumatic Brain Injury · Phase 2 · not yet recruiting
- NCT04838301 — Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease · Phase 2 · recruiting
- NCT03748303 — Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study · Phase 1 · terminated
- NCT04015869 — Effect of Allopregnanolone on Stress-induced Craving · Phase 1 · completed
Other recruiting trials for Parkinson Disease
Currently open trials in the same condition.
- NCT07399496 — Accelerated TMS for Apathy in PD · NA · recruiting
- NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
- NCT07442370 — The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients · NA · recruiting
- NCT06848205 — Percept Transitions in FOG and PD · NA · recruiting
- NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · recruiting
Other Roberta Brinton trials
Trials by the same sponsor.
- NCT05664477 — PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06263010 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Roberta Brinton
- Last refreshed: 13 March 2026
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing