Idiopathic Parkinson Disease Clinical Trial
— yFFPOfficial title:
Intravenous Young Fresh Frozen Plasma (yFFP) Investigational Treatment for Parkinson's Disease
Verified date | May 2024 |
Source | The Neurology Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 8, 2019 |
Est. primary completion date | August 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Neurology Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The Neurology Center | Carolina Longevity Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Physician assessment | Unified Parkinson Disease Rating Scale (UPDRS) | Two weeks prior to infusion, at one-three-six months post-infusion | |
Primary | Patient assessment | Changes in Stanford Presenteeism Scale (SPS) | Two weeks prior to infusion, at one-three-six months post-infusion | |
Secondary | Stability of administration | Adverse events (if any) | At the time of infusions, day 1 and day 2 | |
Secondary | Factors predicting a beneficial response | Patient Global Impression of change | After the last participant's final contact at 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05103618 -
Effect of Meditation and Controls and Subjects With Parkinson's Disease on Brain Activity Measured by fMRI With FDOPA
|
Phase 2 | |
Completed |
NCT03700684 -
Voice Treatment for Parkinson's Disease
|
N/A | |
Completed |
NCT05027620 -
Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology
|
N/A | |
Completed |
NCT03652363 -
GDNF in ideopathicParkinsons Disease
|
Phase 2 | |
Recruiting |
NCT02960464 -
tDCS for Treatment of Depression in Parkinson's Disease
|
N/A | |
Completed |
NCT05699161 -
Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson
|
Phase 1/Phase 2 | |
Completed |
NCT03944785 -
Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
|
||
Completed |
NCT01227265 -
Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
|
Phase 3 | |
Terminated |
NCT01215227 -
An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)
|
Phase 3 | |
Withdrawn |
NCT05832775 -
Study to Assess the Safety of MRx0029 or MRx0005 Compared to Placebo, in People With Parkinson's
|
Phase 1 | |
Active, not recruiting |
NCT02780895 -
Parkinsonian Brain Repair Using Human Stem Cells
|
Phase 1 | |
Recruiting |
NCT01860794 -
Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
|
Phase 1/Phase 2 | |
Completed |
NCT02373072 -
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
|
Phase 1 | |
Terminated |
NCT02393027 -
Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999
|
Early Phase 1 | |
Completed |
NCT02445651 -
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
|
N/A | |
Completed |
NCT00437125 -
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
|
Phase 4 | |
Completed |
NCT02723396 -
Sleep, Awake & Move - Part I
|
||
Completed |
NCT00599339 -
Transdermal Rotigotine User Surveillance Study
|
||
Suspended |
NCT05471609 -
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
|
Early Phase 1 | |
Completed |
NCT00160576 -
Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias
|
Phase 2 |