Idiopathic Parkinson DiseaseEarly Phase 1yFFPNCT04202757
Intravenous Plasma Treatment for Parkinson's Disease
A Early Phase 1 study testing [21CFR640.30] Plasma from 18 - 25 year old volunteer donors and Saline in people with Idiopathic Parkinson Disease, run by The Neurology Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- [21CFR640.30] Plasma from 18 - 25 year old volunteer donors and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 8 Aug 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Young Fresh Frozen Plasma (yFFP) Investigational Treatment for Parkinson's Disease
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.
Read the 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.
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- [21CFR640.30] Plasma from 18 - 25 year old volunteer donors, Saline
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[21CFR640.30] Plasma from 18 - 25 year old volunteer donorsBiological
Also called Young Fresh Frozen Plasma (yFFP)
12.5 ml/kg intravenous Spectrum Plasma yFFP, per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.
SalineOther
Also called Normal saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Young Fresh Frozen Plasma (yFFP) | Active comparator | [21CFR640.30] Plasma from 18 - 25 year old volunteer donors Receives: Biological: [21CFR640.30] Plasma from 18 - 25 year old volunteer donors |
| Saline | Placebo comparator | 0.1% riboflavin in normal saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Physician assessment
Unified Parkinson Disease Rating Scale (UPDRS)
Measured: Two weeks prior to infusion, at one-three-six months post-infusion
Patient assessment
Changes in Stanford Presenteeism Scale (SPS)
Measured: Two weeks prior to infusion, at one-three-six months post-infusion
Secondary outcomes (2)
Stability of administration
Adverse events (if any)
Measured: At the time of infusions, day 1 and day 2
Factors predicting a beneficial response
Patient Global Impression of change
Measured: After the last participant's final contact at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start24 Sep 2018
- Primary completion7 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Neurology Center
- Sponsor type
- University, hospital or other
- Collaborators
- Carolina Longevity Institute
- Responsible party
- Sponsor
- Investigators
- Dian Ginsberg, M.D., Principal investigator, The Ginstitute of Functional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202757
- Sponsor's protocol ID
- NeurologyCenter
- Acronym
- yFFP
- Status last verified
- May 2024
- First submitted
- 21 Sep 2018
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Young Fresh Frozen Plasma (yFFP) Investigational Treatment for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04202757
- Acronym / sponsor ID
- yFFP / NeurologyCenter
- Conditions
- Idiopathic Parkinson Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Neurology CenterUniversity, hospital or other
- Collaborators
- Carolina Longevity Institute
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Young Fresh Frozen Plasma (yFFP) | Active comparator | Biological: [21CFR640.30] Plasma from 18 - 25 year old volunteer donors[21CFR640.30] Plasma from 18 - 25 year old volunteer donors |
| Saline | Placebo comparator | Other: Saline0.1% riboflavin in normal saline |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [21CFR640.30] Plasma from 18 - 25 year old volunteer donorsAlso: Young Fresh Frozen Plasma (yFFP)12.5 ml/kg intravenous Spectrum Plasma yFFP, per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment. | Biological | Young Fresh Frozen Plasma (yFFP) |
| SalineAlso: Normal saline12.5 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. | Other | Saline |
Primary outcome
Changes in Physician assessment
Time frame: Two weeks prior to infusion, at one-three-six months post-infusion
Unified Parkinson Disease Rating Scale (UPDRS)
Patient assessment
Time frame: Two weeks prior to infusion, at one-three-six months post-infusion
Changes in Stanford Presenteeism Scale (SPS)
2 secondary outcomes
Stability of administration
Time frame: At the time of infusions, day 1 and day 2
Factors predicting a beneficial response
Time frame: After the last participant's final contact at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dian Ginsberg, M.D. principal investigator
The Ginstitute of Functional Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [21CFR640.30] Plasma from 18 - 25 year old volunteer donors and Saline in people with Idiopathic Parkinson Disease, run by The Neurology Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Physician assessment (time frame: Two weeks prior to infusion, at one-three-six months post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.