NCT04202757

Intravenous Plasma Treatment for Parkinson's Disease

Intravenous Young Fresh Frozen Plasma (yFFP) Investigational Treatment for Parkinson's Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: The Neurology Center · Academic / Other
• Sex: All
• Age: 45 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study will do a preliminary evaluation of a possible treatment for mild-to-moderate Parkinson's disease. Patients will be treated with either transfusions of plasma from young donors. or with placebo transfusions. In the following several months, Parkinson's symptoms will be monitored and compared for the two groups.

Detailed description

This is a double-blind placebo controlled trial, designed to evaluate the efficacy of plasma from volunteer donors of ages 18-25. This young fresh frozen plasma (yFFP) will be given intravenously in two doses of 12.5 ml/kg each, with 40-56 hours between doses. In the following 24 weeks, Parkinson's symptoms will be monitored using the short version of the Stanford Presenteeism Scale (SPS-6), and a modified version of the UPDRS scale.

Conditions

• Idiopathic Parkinson Disease

Interventions

Type	Name	Description
BIOLOGICAL	[21CFR640.30] Plasma from 18 - 25 year old volunteer donors	12.5 ml/kg intravenous Spectrum Plasma yFFP, per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.
OTHER	Saline	12.5 ml/kg intravenous 0.9% sodium chloride with 0.1% riboflavin , per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.

Timeline

• Start date: 2018-09-24
• Primary completion: 2019-08-07
• Completion: 2019-08-08
• First posted: 2019-12-18
• Last updated: 2024-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study