Parkinson DiseaseNCT02060695
Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations
An observational study of Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with Parkinson's disease. Observational study case-only Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Jun 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: movement disorder clinic
Who may be able to join
- clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society Brain Bank criteria
- early stage
Who cannot join
- dementia (MMSE<26)
- persons who refuse participating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Beom S Jeon, MD, PhD, 82-2-2072-2876, brain@snu.ac.kr
About this study
The purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with Parkinson's disease.
Observational study case-only
Read the detailed description
Objectives
- how many patients will experience motor or nonmotor fluctuation during follow-up period?
- in how many patients, does motor fluctuation precede nonmotor fluctuation?
- in how many patients, does nonmotor fluctuation precede motor fluctuation?
Participants: persons with Parkinson disease in early stage who does not have motor or nonmotor fluctuation
Recruitment period: 3 years from the commencement of the study Follow-up period: 3 years for each participants
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
time period from the onset of disease to the occurrence of motor or nonmotor fluctuation
The proportion of participants with motor and/or nonmotor fluctuation will be evaluated at 6, 12, 18, 24, 30, and 36 months after the enrollment of each participant in order to determine the time course of motor/nonmotor fluctuation in persons with early stage of Parkinson's disease.
Measured: 6 months
Secondary outcomes (1)
sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation
The participants will be checked regularly for the development of motor/nonmotor fluctuation during study period by both of self-diagnostic questionnaire and clinician. The validation of self-diagnostic questionnaire of motor/nonmotor fluctuation will be conducted compared to the clinician-evaluated occurrence of motor/nonmotor fluctuation.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2030 (estimated)
- Study completionJun 2031 (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 Seoul National University HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BS Jeon, Seoul National University Hospital
- Investigators
- Beom S Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060695
- Sponsor's protocol ID
- H-1109-081-378
- Status last verified
- May 2017
- First submitted
- 3 Feb 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Witjas T, Kaphan E, Azulay JP, Blin O, Ceccaldi M, Pouget J, Poncet M, Cherif AA. Nonmotor fluctuations in Parkinson's disease: frequent and disabling. Neurology. 2002 Aug 13;59(3):408-13. doi: 10.1212/wnl.59.3.408.
PubMed 12177375Resnick RJ, Kole HK, Racker E. Multiple changes induced by cholera toxin contribute to the stimulation of aerobic lactate production in rat-1 fibroblasts. Arch Biochem Biophys. 1991 May 1;286(2):579-85. doi: 10.1016/0003-9861(91)90083-u.
PubMed 1654794Stacy M, Hauser R. Development of a Patient Questionnaire to facilitate recognition of motor and non-motor wearing-off in Parkinson's disease. J Neural Transm (Vienna). 2007 Feb;114(2):211-7. doi: 10.1007/s00702-006-0554-y. Epub 2006 Aug 10.
PubMed 16897594
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations
- ClinicalTrials.gov ID
- NCT02060695
- Acronym / sponsor ID
- H-1109-081-378
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 12 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.
The purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with Parkinson's disease.
Observational study case-only
Detailed description
Objectives
- how many patients will experience motor or nonmotor fluctuation during follow-up period?
- in how many patients, does motor fluctuation precede nonmotor fluctuation?
- in how many patients, does nonmotor fluctuation precede motor fluctuation?
Participants: persons with Parkinson disease in early stage who does not have motor or nonmotor fluctuation
Recruitment period: 3 years from the commencement of the study Follow-up period: 3 years for each participants
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- movement disorder clinic
Key inclusion criteria (2 listed)
- clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society Brain Bank criteria
- early stage
Key exclusion criteria (2 listed)
- dementia (MMSE<26)
- persons who refuse participating
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
time period from the onset of disease to the occurrence of motor or nonmotor fluctuation
Time frame: 6 months
The proportion of participants with motor and/or nonmotor fluctuation will be evaluated at 6, 12, 18, 24, 30, and 36 months after the enrollment of each participant in order to determine the time course of motor/nonmotor fluctuation in persons with early stage of Parkinson's disease.
1 secondary outcome
sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Background: PubMed 12177375Witjas T, Kaphan E, Azulay JP, Blin O, Ceccaldi M, Pouget J, Poncet M, Cherif AA. Nonmotor fluctuations in Parkinson's disease: frequent and disabling. Neurology. 2002 Aug 13;59(3):408-13. doi: 10.1212/wnl.59.3.408.
- Background: PubMed 1654794Resnick RJ, Kole HK, Racker E. Multiple changes induced by cholera toxin contribute to the stimulation of aerobic lactate production in rat-1 fibroblasts. Arch Biochem Biophys. 1991 May 1;286(2):579-85. doi: 10.1016/0003-9861(91)90083-u.
- Background: PubMed 16897594Stacy M, Hauser R. Development of a Patient Questionnaire to facilitate recognition of motor and non-motor wearing-off in Parkinson's disease. J Neural Transm (Vienna). 2007 Feb;114(2):211-7. doi: 10.1007/s00702-006-0554-y. Epub 2006 Aug 10.
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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.
Beom S Jeon, MD, PhD principal investigator
Seoul National University Hospital
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 Seoul National University Hospital at 1 site in South Korea.
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 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: looking for participants now, as of the sponsor's last update on 3 May 2017. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beom S Jeon, MD, PhD (82-2-2072-2876, brain@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time period from the onset of disease to the occurrence of motor or nonmotor fluctuation (time frame: 6 months). 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 NCT02060695, 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 3 May 2017.