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Intravenous Plasma Treatment for Parkinson's Disease (yFFP)

Primary Purpose

Idiopathic Parkinson Disease

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

[21CFR640.30] Plasma from 18 - 25 year old volunteer donors

Saline

About this trial

This is an interventional treatment trial for Idiopathic Parkinson Disease

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Parkinson's disease
Disease duration of 1 to 5 years
Willingness to confirm the use of adequate birth control while on the trial will be required in premenopausal women without evidence for an inability to become pregnant.
Willingness to not start any other treatment for Parkinson's or Multiple Sclerosis during the parallel part of the trial.

Exclusion Criteria:

Other significant disease, which in the view of the study doctor may make assessment of the efficacy of yFFP difficult.
Unstable medical conditions.
Must weigh at least 45.5 kg. Cannot weigh more than 130 kg.
A severe disease state diagnosis
Litigation. Patients in litigation will be excluded only if conclusion of that litigation is imminent during the course of the study.
If patient is pregnant or breastfeeding.
Complete IgA deficiency.
Rare contraindications to yFFP therapy as per summary of product characteristics.
Receiving yFFP for other reasons.
Ongoing drug or alcohol abuse.
Psychiatric disorder that could, in the judgement of the site investigator, interfere with successful study participation.
Unwillingness or inability to complete the study or an inability to understand the questionnaires being used.
Cancer other than basal cell carcinoma within the last 5 years. However, those patients who have received definitive treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included.
A history of hypercoagulable or thrombophilic clotting abnormalities.
A history of thromboembolic events: ischaemic stroke, confirmed myocardial infarction, pulmonary embolism; deep venous thrombosis except where immobility related (for example, after injury or operation).
Unstable angina pectoris.
Medications that might react with yFFP such as blood thinners
Renal failure or serum creatinine greater than 1.5 times the upper limit of normal at screening.
Any medical condition that, in the opinion of the investigator, would make it unsafe for the patient to participate or which would interfere with assessment of the outcome measures.
Participation in another interventional trial within 3 months of randomization. Participation in non-interventional studies is not a reason for exclusion.

Sites / Locations

The Neurology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Young Fresh Frozen Plasma (yFFP)

Saline

Arm Description

[21CFR640.30] Plasma from 18 - 25 year old volunteer donors

0.1% riboflavin in normal saline

Outcomes

Primary Outcome Measures

Changes in Physician assessment

Unified Parkinson Disease Rating Scale (UPDRS)

Patient assessment

Changes in Stanford Presenteeism Scale (SPS)

Secondary Outcome Measures

Stability of administration

Adverse events (if any)

Factors predicting a beneficial response

Patient Global Impression of change

Full Information

NCT ID

NCT04202757

First Posted

September 21, 2018

Last Updated

December 14, 2021

Sponsor

The Neurology Center

Collaborators

Carolina Longevity Institute

1. Study Identification

Unique Protocol Identification Number

NCT04202757

Brief Title

Intravenous Plasma Treatment for Parkinson's Disease

Acronym

yFFP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

September 14, 2018 (Actual)

Primary Completion Date

August 7, 2019 (Actual)

Study Completion Date

August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Neurology Center

Collaborators

Carolina Longevity Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Placebo controlled trial

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

Blinding will be achieved by preparing both yFFP and placebo (0.1% riboflavin in normal saline) solution into identical-sized, masked bags. The riboflavin is added to the saline to achieve indistinguishable color when compared to the yFFP. Physicians who evaluate patients are masked from treatment assignment.

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Young Fresh Frozen Plasma (yFFP)

Arm Type

Active Comparator

Arm Description

[21CFR640.30] Plasma from 18 - 25 year old volunteer donors

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

0.1% riboflavin in normal saline

Intervention Type

Biological

Intervention Name(s)

[21CFR640.30] Plasma from 18 - 25 year old volunteer donors

Other Intervention Name(s)

Young Fresh Frozen Plasma (yFFP)

Intervention Description

12.5 ml/kg intravenous Spectrum Plasma yFFP, per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.

Intervention Type

Other

Intervention Name(s)

Saline

Other Intervention Name(s)

Normal saline

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in Physician assessment

Description

Unified Parkinson Disease Rating Scale (UPDRS)

Time Frame

Two weeks prior to infusion, at one-three-six months post-infusion

Title

Patient assessment

Description

Changes in Stanford Presenteeism Scale (SPS)

Time Frame

Two weeks prior to infusion, at one-three-six months post-infusion

Secondary Outcome Measure Information:

Title

Stability of administration

Description

Adverse events (if any)

Time Frame

At the time of infusions, day 1 and day 2

Title

Factors predicting a beneficial response

Description

Patient Global Impression of change

Time Frame

After the last participant's final contact at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Parkinson's disease Disease duration of 1 to 5 years Willingness to confirm the use of adequate birth control while on the trial will be required in premenopausal women without evidence for an inability to become pregnant. Willingness to not start any other treatment for Parkinson's or Multiple Sclerosis during the parallel part of the trial. Exclusion Criteria: Other significant disease, which in the view of the study doctor may make assessment of the efficacy of yFFP difficult. Unstable medical conditions. Must weigh at least 45.5 kg. Cannot weigh more than 130 kg. A severe disease state diagnosis Litigation. Patients in litigation will be excluded only if conclusion of that litigation is imminent during the course of the study. If patient is pregnant or breastfeeding. Complete IgA deficiency. Rare contraindications to yFFP therapy as per summary of product characteristics. Receiving yFFP for other reasons. Ongoing drug or alcohol abuse. Psychiatric disorder that could, in the judgement of the site investigator, interfere with successful study participation. Unwillingness or inability to complete the study or an inability to understand the questionnaires being used. Cancer other than basal cell carcinoma within the last 5 years. However, those patients who have received definitive treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included. A history of hypercoagulable or thrombophilic clotting abnormalities. A history of thromboembolic events: ischaemic stroke, confirmed myocardial infarction, pulmonary embolism; deep venous thrombosis except where immobility related (for example, after injury or operation). Unstable angina pectoris. Medications that might react with yFFP such as blood thinners Renal failure or serum creatinine greater than 1.5 times the upper limit of normal at screening. Any medical condition that, in the opinion of the investigator, would make it unsafe for the patient to participate or which would interfere with assessment of the outcome measures. Participation in another interventional trial within 3 months of randomization. Participation in non-interventional studies is not a reason for exclusion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dian Ginsberg, M.D.

Organizational Affiliation

The Ginstitute of Functional Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Neurology Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intravenous Plasma Treatment for Parkinson's Disease

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