Parkinson DiseaseJ-FIRSTNCT02073981
Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients
An observational study of Parkinson Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This study is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson Disease
- How many people
- 1,021 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2014to Jun 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson Disease
Who may be able to join
- Patients who have wearing off under treatment with levodopa-containing drugs administered at least three times daily
- Patients who have at least one non-motor symptom as a complication
- Patients at least 20 years of age at the time of consent
- Patients who have given written consent
- Patients who are receiving outpatient care
Who cannot join
- Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE)
- Patients, in the opinion of the investigator or subinvestigator, having conditions impairing the proper assessment of the MDS-UPDRS or PDQ-8 (e.g., patients who are receiving treatment for malignant tumor)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Japan-First-in Large Scale Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients.
This study is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms or QOL.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
MDS-UPDRS score will be collected from all registrant at each visit and on the last day of survey.
Measured: 52 weeks
Changing of Parkinson's Disease Questionaire-8 (PDQ-8) score.
PDQ-8 score will be collected from all registrant at each visit and on the last day of survey.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073981
- Sponsor's protocol ID
- J-FIRST
- Acronym
- J-FIRST
- Status last verified
- Aug 2023
- First submitted
- 26 Feb 2014
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japan-First-in Large Scale Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients.
- ClinicalTrials.gov ID
- NCT02073981
- Acronym / sponsor ID
- J-FIRST / J-FIRST
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 28 Feb 2014 (estimated)
- 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 is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms or QOL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson Disease
Key inclusion criteria (5 listed)
- Patients who have wearing off under treatment with levodopa-containing drugs administered at least three times daily
- Patients who have at least one non-motor symptom as a complication
- Patients at least 20 years of age at the time of consent
- Patients who have given written consent
- Patients who are receiving outpatient care
Key exclusion criteria (2 listed)
- Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE)
- Patients, in the opinion of the investigator or subinvestigator, having conditions impairing the proper assessment of the MDS-UPDRS or PDQ-8 (e.g., patients who are receiving treatment for malignant tumor)
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
Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 52 weeks
MDS-UPDRS score will be collected from all registrant at each visit and on the last day of survey.
Changing of Parkinson's Disease Questionaire-8 (PDQ-8) score.
Time frame: 52 weeks
PDQ-8 score will be collected from all registrant at each visit and on the last day of survey.
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 7 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 5 inclusion and 2 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 7 Aug 2023. 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 Japan. 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. 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?
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?
Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: 52 weeks). 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 7 Aug 2023.