Intravenous Plasma Treatment for Parkinson's Disease

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.

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.