Parkinson's DiseaseNCT01662427
Nocturnal Parkinson's Disease Symptoms Study Group
An observational study of Parkinson's Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in Parkinson's disease patients and caregivers. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Questionaire to assess Noctural Parkinson's Disease Symptoms
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2012to Aug 2013
- 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's disease patient and care givers
Who may be able to join
- Idiopathic Parkinson's disease patient
Who cannot join
- Patient with Secondary Parkinsonism eg.Drug-induced Parkinsonism, Vascular Parkinsonism, exposure to toxin, Encephalitis
- Patient with Atypical Parkinsonial Syndromes eg. Parkinson-plus syndrome, Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD)
- Patient with Heredodegenerative parkinsonism eg. Spinocerebellar ataxias, Wilson's disease, Juvenile Huntington's disease
Trial locations and contacts
1 site in 1 country.
About this study
To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in Parkinson's disease patients and caregivers.
- Conditions
- Parkinson's Disease
- Being tested
- Questionaire to assess Noctural Parkinson's Disease Symptoms
- Keywords
- Quality of life, Noctural Parkinson's Disease Symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionaire to assess Noctural Parkinson's Disease SymptomsOther
Questionaire to assess Noctural Parkinson's Disease Symptoms and quality of life
| Study group | Role | What they receive |
|---|---|---|
| Questionniare | Not described Receives: Other: Questionaire to assess Noctural Parkinson's Disease Symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess Noctural Parkinson's Disease Symptoms
Secondary outcomes (2)
To assess quality of life in Parkinson's Disease patient
To assess quality of life in caregiver of Parkinson's Disease patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roongroj Bhidayasiri, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662427
- Sponsor's protocol ID
- 6222012
- Status last verified
- Aug 2013
- First submitted
- 7 Aug 2012
- Last updated
- 20 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Parkinson's Disease Symptoms Study Group
- ClinicalTrials.gov ID
- NCT01662427
- Acronym / sponsor ID
- 6222012
- Conditions
- Parkinson's Disease
- Keywords
- Quality of life, Noctural Parkinson's Disease Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Aug 2012 (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.
To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in Parkinson's disease patients and caregivers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionniare | – | Other: Questionaire to assess Noctural Parkinson's Disease Symptoms |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patient and care givers
Key inclusion criteria (1 listed)
- Idiopathic Parkinson's disease patient
Key exclusion criteria (3 listed)
- Patient with Secondary Parkinsonism eg.Drug-induced Parkinsonism, Vascular Parkinsonism, exposure to toxin, Encephalitis
- Patient with Atypical Parkinsonial Syndromes eg. Parkinson-plus syndrome, Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD)
- Patient with Heredodegenerative parkinsonism eg. Spinocerebellar ataxias, Wilson's disease, Juvenile Huntington's disease
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 |
|---|---|---|
| Questionaire to assess Noctural Parkinson's Disease SymptomsQuestionaire to assess Noctural Parkinson's Disease Symptoms and quality of life | Other | Questionniare |
Primary outcome
To assess Noctural Parkinson's Disease Symptoms
2 secondary outcomes
To assess quality of life in Parkinson's Disease patient
To assess quality of life in caregiver of Parkinson's Disease patient
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 20 Aug 2013.
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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's Disease, run by Chulalongkorn University at 1 site in Thailand.
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 1 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: finished, as of the sponsor's last update on 20 Aug 2013. 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 Thailand. 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?
To assess Noctural Parkinson's Disease Symptoms. 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 20 Aug 2013.