Allopregnanolone as a Regenerative Treatment for Parkinson's Disease (Allo-PD)

[Boscoejean]

I just happened upon this trial and it is something I had never heard of. It looks like a very small trial being conducted in Tucson, AZ.

clinicaltrials.gov/study/NC...

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. 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.

[JayPwP]

Interesting... Have to learn more about this...

[Bolt_Upright]

Allopregnanolone

Medication

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

Protein binding: >99%

Routes of administration: Intravenous

[Boscoejean]

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

Tucson, Arizona, United States, 85721

[Canddy]

Thanks for this post - I will look into it as the investigator is my MDS/neurologist