This is an open-label, pilot clinical trial of allopregnanolone (Allo) as a regenerative treatment for Parkinson's disease. A total of 10 study participants will receive weekly infusions of Allo for 12 weeks. Participants will be male and female, age 40-80 years with a history of idiopathic, sporadic PD who have a Hoehn & Yahr stage 1-4. Allo is a potent neuroregenerative agent that promotes proliferation of human neural stem cells and has the potential to function as a regenerative therapeutic to restore motor function in persons with PD. Results from several preclinical studies in rodent models of PD confirm improved motor function after Allo treatment.
Primary Objective: To assess the feasibility of a large-scale trial to determine the efficacy of weekly infusions of Allo in in patients with Idiopathic sporadic PD.
Secondary Objectives: To evaluate the safety and tolerability of weekly infusions of Allo in participants with idiopathic sporadic PD, and assess single-dose pharmacokinetics of allopregnanolone.
Tertiary / Exploratory Objectives: To assess efficacy signals of weekly infusions of Allo in participants with idiopathic sporadic PD.
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Boscoejean
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Allopregnanolone is a naturally occurring neurosteroid which is made in the body from the hormone progesterone. As a medication, allopregnanolone is referred to as brexanolone, sold under the brand name Zulresso, and used to treat postpartum depression. It is given by injection into a vein. Wikipedia
AHFS/Drugs.com: Monograph
ATC code: N06AX29 (WHO)
Bioavailability: Oral: <5%
Elimination half-life: 9 hours
License data: US DailyMed: Brexanolone; US FDA: Zulresso
it sounds like this trial will only have 10 participants
"Brief 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:
Is a large-scale clinical trial testing how well it works in patients with PD feasible?
Is allopregnanolone safe and well-tolerated in patients with PD.
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.
Detailed Description:
This is an open-label, pilot clinical trial of allopregnanolone (Allo) as a regenerative treatment for Parkinson's disease. A total of 10 study participants will receive weekly infusions of Allo for 12 weeks. Participants will be male and female, age 40-80 years with a history of idiopathic, sporadic PD who have a Hoehn & Yahr stage 1-4. Allo is a potent neuroregenerative agent that promotes proliferation of human neural stem cells and has the potential to function as a regenerative therapeutic to restore motor function in persons with PD"
only being done in Tucson, AZ
United States, Arizona
The University of Arizona Clinical & Translational Science Research Center Recruiting
Good to see some potential regenerative treatments being trialled.
I believe allopregnanolone is under patent in the US, or used to be. But the good news is pregnenolone is a precursor hormone that eventually gets turned into allopregnanolone in the brain, so supplementing pregnenolone could, possibly have a similar effect.
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