NCT06263010CompletedPhase 1
Allopregnanolone as a Regenerative Treatment for Parkinson's Disease
Allopregnanolone as a Regenerative Treatment for Parkinson's Disease: An Open-label, Pilot Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 8 Feb 2024
- Start date
- 12 Jan 2024
- Primary completion date
- 15 Jul 2025
- Lead sponsor
- Roberta Brinton
- Diseases
- Parkinson disease
- NCT number
- NCT06263010
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 12 Jan 2024 to the primary completion date, 15 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Undergone deep brain stimulation (DBS) surgery as treatment for PD.
- Treatment with another investigational drug within 3 months of screening.
Other illness
- Evidence of Parkinsonian syndrome.
- Any conditions that would contraindicate MRI studies.
- Iodine allergy, known serious hypersensitivity to ioflupane I-123, or other inability to undergo DaTscan.
- History within the last 5 years of a primary or recurrent malignant disease, with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or prostate cancer in situ with a post-treatment prostatic-specific antigen within normal range.
- Serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than PD), psychiatric, immunologic, or hematologic disease, and any other conditions that, in the investigator's opinion, could interfere with the safety and efficacy analyses in this study.
- History of chronic alcohol or substance abuse/dependence within the past 3 years.
Lab values
- Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- Current use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the gamma-aminobutyric acid-A (GABA-A) receptor complex; use of calcium-channel blockers (e.g., amlodipine); use of dietary supplements containing Pregnenolone.
Who the study is looking for
- History of Idiopathic sporadic Parkinson disease
- Hoehn \& Yahr stage 1-4
- Have been on stable doses of all anti-Parkinson's medications for 30 days prior to screening
- Provision of signed and dated informed consent form
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Arizona Clinical & Translational Science Research Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.