Parkinson DiseaseNCT05685329
Determining Patterns In Trial Experiences of Parkinson's Disease Patients
An observational study of Parkinson Disease, run by Power Life Sciences Inc..
Trial summary
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This study will invite several participants to gather a wide range of information on clinical trial experiences for Parkinson's Disease patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with Parkinson's Disease who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.
Who may be able to join
- Patient plans to participate in an interventional clinical trial for the condition of Parkinson's Disease
- Patient has been diagnosed with a type of Parkinson's Disease
- Patient is at least 50 to 80 years of age
- Patient has access to a home internet connection in order to provide regular updates through the course of the study
Who cannot join
- Patient has an ECOG score of 4 or higher
- Patient is not able to provide consistent digital updates as per study requirements
- Patient does not complete or agree to terms outlined in the Informed Consent Form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An In Depth Study Examining Patterns in the Clinical Trial Experiences of Parkinson's Disease Patients
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.
This study will invite several participants to gather a wide range of information on clinical trial experiences for Parkinson's Disease patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of Parkinson's Disease.
The data collected from this study will help improve future outcomes for all Parkinson's Disease patients as well as those in under-represented demographic groups.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Parkinson's
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to enroll in an Parkinson's Disease clinical trial
Measured: 3 months
Rate of patients who remain in Parkinson's Disease clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685329
- Sponsor's protocol ID
- 87526739
- Status last verified
- Jun 2023
- First submitted
- 5 Jan 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reich SG, Savitt JM. Parkinson's Disease. Med Clin North Am. 2019 Mar;103(2):337-350. doi: 10.1016/j.mcna.2018.10.014. Epub 2018 Dec 3.
PubMed 30704685Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
PubMed 32044947McFarthing K, Rafaloff G, Baptista M, Mursaleen L, Fuest R, Wyse RK, Stott SRW. Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2022 Update. J Parkinsons Dis. 2022;12(4):1073-1082. doi: 10.3233/JPD-229002.
PubMed 35527571
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In Depth Study Examining Patterns in the Clinical Trial Experiences of Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT05685329
- Acronym / sponsor ID
- 87526739
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Parkinson's
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 17 Jan 2023 (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.
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.
This study will invite several participants to gather a wide range of information on clinical trial experiences for Parkinson's Disease patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of Parkinson's Disease.
The data collected from this study will help improve future outcomes for all Parkinson's Disease patients as well as those in under-represented demographic groups.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.
Key inclusion criteria (4 listed)
- Patient plans to participate in an interventional clinical trial for the condition of Parkinson's Disease
- Patient has been diagnosed with a type of Parkinson's Disease
- Patient is at least 50 to 80 years of age
- Patient has access to a home internet connection in order to provide regular updates through the course of the study
Key exclusion criteria (3 listed)
- Patient has an ECOG score of 4 or higher
- Patient is not able to provide consistent digital updates as per study requirements
- Patient does not complete or agree to terms outlined in the Informed Consent Form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who decide to enroll in an Parkinson's Disease clinical trial
Time frame: 3 months
Rate of patients who remain in Parkinson's Disease clinical trial to trial completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 30704685Reich SG, Savitt JM. Parkinson's Disease. Med Clin North Am. 2019 Mar;103(2):337-350. doi: 10.1016/j.mcna.2018.10.014. Epub 2018 Dec 3.
- Background: PubMed 32044947Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
- Background: PubMed 35527571McFarthing K, Rafaloff G, Baptista M, Mursaleen L, Fuest R, Wyse RK, Stott SRW. Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2022 Update. J Parkinsons Dis. 2022;12(4):1073-1082. doi: 10.3233/JPD-229002.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Power Life Sciences Inc..
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 3 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill ((415) 900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to enroll in an Parkinson's Disease clinical trial (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT05685329, which also lists 3 linked publications.
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 18 Jun 2023.