Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT04202757
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
90 Years
Study:
NCT04202757
Study Brief:
Protocol Section:
NCT04202757