Parkinson DiseasePDDIFFUNCT04453995
A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease
An observational study of Parkinson Disease and Dyskinesias, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Parkinson' patients who have not had dyskinesia would be observed for 2 years in a multicenter prospective study with the purposes to clarify the predicting factors of dyskinesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Dyskinesias
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2019to 1 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: a 2 years prospective study to identify the predicting factors of dyskinesia in Parkinson' patients that have received Levodopa treatment.
Who may be able to join
- 1) Patients have been clinically diagnosed with Parkinson disease at the recruitment.
- 2) Patients have received Levodopa treatment with the daily dosage above 200mg.
Who cannot join
- 1) be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have experienced dyskinesia. 3) incorporation to the investigation
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua hospital affiliated to Shanghai jiaotong university school of medicine
Shanghai, Shanghai Municipality, 200092
About this study
Parkinson' patients who have not had dyskinesia would be observed for 2 years in a multicenter prospective study with the purposes to clarify the predicting factors of dyskinesia.
Read the detailed description
Parkinson' patients with daily levodopa dosage above 200mg and no dyskinesia would be recruited into the study. They would be observed for two years for analyzed the predicting factors of dyskinesia. At the baseline, demographic information, Clinical information, blood sample, picture of tongure coating would be collected at the baseline. All participants were evaluated every three months for two years. The severity of motor symptoms were evaluated every 6 months.
- Conditions
- Parkinson Disease, Dyskinesias
- Keywords
- Parkinson disease, Dyskinesia, follow up
- Medical subject headings
- Parkinson Disease, Dyskinesias
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of dyskinesia and its related predicting factors
to evaluate the occurrence of dyskinesia during the 2 years of follow-up and identify its predicting factors of dyskinesia
Measured: The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.
Secondary outcomes (1)
to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up
to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up
Measured: The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start5 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
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 Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Hospital of Traditional Chinese Medicine, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Second Affiliated Hospital of Soochow University, Nanjing Medical University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital with Nanjing Medical University, Zhejiang Provincial Tongde Hospital, Shaoxing Hospital of Traditional Chinese medicine, The First People Hospital of Hangzhou Lin An District
- Responsible party
- Sponsor
- Investigators
- zhenguo Liu, Ph.D., Study chair, Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453995
- Sponsor's protocol ID
- XH-19-014
- Acronym
- PDDIFFU
- Status last verified
- Dec 2019
- First submitted
- 27 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There would be digital data of all the information that collected in the study. But it is still unknown that the data would be available freely
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04453995
- Acronym / sponsor ID
- PDDIFFU / XH-19-014
- Conditions
- Parkinson Disease, Dyskinesias
- Keywords
- Parkinson disease, Dyskinesia, follow up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Municipal Hospital of Traditional Chinese Medicine, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Second Affiliated Hospital of Soochow University, Nanjing Medical University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital with Nanjing Medical University, Zhejiang Provincial Tongde Hospital, Shaoxing Hospital of Traditional Chinese medicine, The First People Hospital of Hangzhou Lin An District
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 1 Jul 2020 (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.
Parkinson' patients who have not had dyskinesia would be observed for 2 years in a multicenter prospective study with the purposes to clarify the predicting factors of dyskinesia.
Detailed description
Parkinson' patients with daily levodopa dosage above 200mg and no dyskinesia would be recruited into the study. They would be observed for two years for analyzed the predicting factors of dyskinesia. At the baseline, demographic information, Clinical information, blood sample, picture of tongure coating would be collected at the baseline. All participants were evaluated every three months for two years. The severity of motor symptoms were evaluated every 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- a 2 years prospective study to identify the predicting factors of dyskinesia in Parkinson' patients that have received Levodopa treatment.
Key inclusion criteria (2 listed)
- 1) Patients have been clinically diagnosed with Parkinson disease at the recruitment.
- 2) Patients have received Levodopa treatment with the daily dosage above 200mg.
Key exclusion criteria (1 listed)
- 1) be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have experienced dyskinesia. 3) incorporation to the investigation
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
the occurrence of dyskinesia and its related predicting factors
Time frame: The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.
to evaluate the occurrence of dyskinesia during the 2 years of follow-up and identify its predicting factors of dyskinesia
1 secondary outcome
to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up
Time frame: The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: Undecided. There would be digital data of all the information that collected in the study. But it is still unknown that the data would be available freely
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
zhenguo Liu, Ph.D. study chair
Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine
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 and Dyskinesias, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 2 inclusion and 1 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 1 Jul 2020. 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 China. 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?
Results are not available in the source record.
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?
the occurrence of dyskinesia and its related predicting factors (time frame: The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.). 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 1 Jul 2020.