Intravenous Plasma Treatment for Parkinson's Disease

NCT04202757 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: NeurologyCenter
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Changes in Physician assessment

  Unified Parkinson Disease Rating Scale (UPDRS)

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

• Patient assessment

  Changes in Stanford Presenteeism Scale (SPS)

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

Secondary Outcomes (2)

• Stability of administration

  At the time of infusions, day 1 and day 2

• Factors predicting a beneficial response

  After the last participant's final contact at 6 months

Study Arms (2)

Young Fresh Frozen Plasma (yFFP)

ACTIVE COMPARATOR

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

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

Saline

PLACEBO COMPARATOR

0.1% riboflavin in normal saline

Other: Saline

Interventions

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

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

Also known as: Young Fresh Frozen Plasma (yFFP)

Young Fresh Frozen Plasma (yFFP)

Saline OTHER

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.

Also known as: Normal saline

Saline

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Neurology Center: lead
• Carolina Longevity Institute: collaborator

Study Sites (1)

The Neurology Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dian Ginsberg, M.D.

  The Ginstitute of Functional Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo controlled trial

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: December 18, 2019
• Study Start: September 24, 2018
• Primary Completion: August 7, 2019
• Study Completion: August 8, 2019
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)