Parkinson DiseaseNCT04713306
Gender Differences in Parkinsonian Patients- a Swedish Register Study
An observational study of Parkinson Disease, run by Region Jönköping County at 1 site in Sweden.
Trial summary
BACKGROUND: The complex impact of gender has been studied in different perspectives of health and disease in the literature. However, few attempts have been made to compile data from systematic disease specific registrations Swedish National Quality Registers play an important role in collecting large amounts of… Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 1,217 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2006to 31 Dec 2019
- How long will I take part?
- 14 Years
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cohorts from rural areas and larger cities of Southern Sweden with diagnosed parkinsonism.
Who may be able to join
- Participants registered in the Swedish Neuro Registers.
- Parkinson´s Disease
- Acceptance of extraction of data
Who cannot join
- non parkinsonian patients
- Participants in the Registries who have not given allowance of extraction of data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender Differences in Diagnostic Tools, Medication, Time to Medication and Non-motor Symptoms in Parkinsonian Patients- a Swedish Register Study
BACKGROUND: The complex impact of gender has been studied in different perspectives of health and disease in the literature. However, few attempts have been made to compile data from systematic disease specific registrations Swedish National Quality Registers play an important role in collecting large amounts of diagnose specific data, symptoms, and treatments. The subset Parkinson Registry has been in use for more than 20 years and are represented in all counties and hospitals where neurological care is provided in Sweden and offer optimal conditions to describe gender specific differences in the use of diagnostic tools, lead times and symptom profiles.
Read the detailed description
Aim: To study differences between gender in diagnostic tools, pharmacological interventions, and self-reported symptoms in Parkinson´s Disease (PD).
METHODS:
Data were extracted from the Swedish Neuro Registers, one of the Swedish National Quality Registers. A mix of urban and rural parts of the country were chosen and data were divided by gender. Self-reported first experienced PD related symptom was used to define the starting point when processing the data. Zero to three years from this point was defined as early symptoms and over three years as late symptoms.
CONCLUSION:
Differences between gender were seen in all chosen aspects, both diagnostically. Distinctions were also prominent in reported NonMotorSymptoms (NMS) profiles. These findings should be important to take into consideration for patients, professional staff, and caregivers in the daily work with gender mixed PD groups.
- Conditions
- Parkinson Disease
- Keywords
- NonMotorSymptoms, medication, National Registries
- 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 |
|---|---|---|
| Participants in the Swedish Neuro Register | Participants are patients with parkinsonian symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between gender
investigations, medications,NonMotorSymptoms
Measured: 2006-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jan 2006
- Primary completion1 May 2019
- Study completion31 Dec 2019
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.
- 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
- Other
- Enrolment
- 1,217 participants (actual)
- Target duration
- 14 Years
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- Jonkoping University, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Johan Lokk, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713306
- Sponsor's protocol ID
- XXXXX
- Status last verified
- Mar 2021
- First submitted
- 6 Oct 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Diagnostic Tools, Medication, Time to Medication and Non-motor Symptoms in Parkinsonian Patients- a Swedish Register Study
- ClinicalTrials.gov ID
- NCT04713306
- Acronym / sponsor ID
- XXXXX
- Conditions
- Parkinson Disease
- Keywords
- NonMotorSymptoms, medication, National Registries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,217 participants (actual)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- Jonkoping University, Karolinska Institutet
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Jan 2021 (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.
BACKGROUND: The complex impact of gender has been studied in different perspectives of health and disease in the literature. However, few attempts have been made to compile data from systematic disease specific registrations Swedish National Quality Registers play an important role in collecting large amounts of diagnose specific data, symptoms, and treatments. The subset Parkinson Registry has been in use for more than 20 years and are represented in all counties and hospitals where neurological care is provided in Sweden and offer optimal conditions to describe gender specific differences in the use of diagnostic tools, lead times and symptom profiles.
Detailed description
Aim: To study differences between gender in diagnostic tools, pharmacological interventions, and self-reported symptoms in Parkinson´s Disease (PD).
METHODS:
Data were extracted from the Swedish Neuro Registers, one of the Swedish National Quality Registers. A mix of urban and rural parts of the country were chosen and data were divided by gender. Self-reported first experienced PD related symptom was used to define the starting point when processing the data. Zero to three years from this point was defined as early symptoms and over three years as late symptoms.
CONCLUSION:
Differences between gender were seen in all chosen aspects, both diagnostically. Distinctions were also prominent in reported NonMotorSymptoms (NMS) profiles. These findings should be important to take into consideration for patients, professional staff, and caregivers in the daily work with gender mixed PD groups.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 14 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants in the Swedish Neuro Register | – | –Participants are patients with parkinsonian symptoms |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohorts from rural areas and larger cities of Southern Sweden with diagnosed parkinsonism.
Key inclusion criteria (3 listed)
- Participants registered in the Swedish Neuro Registers.
- Parkinson´s Disease
- Acceptance of extraction of data
Key exclusion criteria (2 listed)
- non parkinsonian patients
- Participants in the Registries who have not given allowance of extraction of data.
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
Differences between gender
Time frame: 2006-2020
investigations, medications,NonMotorSymptoms
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 30 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Johan Lokk, PhD study director
Karolinska Institutet
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 Region Jönköping County at 1 site in Sweden.
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 3 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 30 Mar 2021. 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 Sweden. 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?
Differences between gender (time frame: 2006-2020). 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 30 Mar 2021.