Parkinson's DiseaseNCT03383497
The Clinical Profile of Parkinson Disease in Egypt
An observational study of Parkinson's Disease, run by Cairo University.
Trial summary
Multi-center, retrospective observational cohort study in 4 tertiary referral centers in Cairo over the period from 2004 to 2016. Study population. including all patients with idiopathic Parkinson disease attending. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 1,237 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2016
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinsonian syndromes
Who may be able to join
- All patients with Parkinsonian syndromes
Who cannot join
- Records with missing operationalized variables from patient records
About this study
Official title: The Clinical Profile of Parkinson Disease in Egypt: A Retrospective Cohort Study
Multi-center, retrospective observational cohort study in 4 tertiary referral centers in Cairo over the period from 2004 to 2016.
Study population. including all patients with idiopathic Parkinson disease attending. Patients were diagnosed in accordance to the United Kingdom - Parkinson Disease Society Brain Bank criteria.
Read the detailed description
Retrospective, observational study that involve Medical Record Review (MRR). Data extraction and collection from medical records was organized through an electronic structured data collection form by two of authors (H.S and N.S).
The abstraction documents included; patient's age, sex, family history, age at onset, type and side of motor symptoms onset, associated non-motor manifestations. Moreover; management plan, drug history, outcome and disease progression were also verified and recorded.
During medical record reviewing (MRR); any missing documentation or poorly recorded information was managed by deleting the case.
- Conditions
- Parkinson's 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 |
|---|---|---|
| Idiopathic Parkinson Disease | Not described | |
| Other Parkinsonian syndromes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to L-Dopa start
The time to L-Dopa start from symptoms onset in relation to time of Diagnosis
Measured: 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
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 Cairo 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
- Retrospective
- Enrolment
- 1,237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Samir Shehata, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383497
- Sponsor's protocol ID
- CU 816
- Status last verified
- Dec 2017
- First submitted
- 12 Sep 2016
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Profile of Parkinson Disease in Egypt: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03383497
- Acronym / sponsor ID
- CU 816
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,237 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Dec 2017 (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.
Multi-center, retrospective observational cohort study in 4 tertiary referral centers in Cairo over the period from 2004 to 2016.
Study population. including all patients with idiopathic Parkinson disease attending. Patients were diagnosed in accordance to the United Kingdom - Parkinson Disease Society Brain Bank criteria.
Detailed description
Retrospective, observational study that involve Medical Record Review (MRR). Data extraction and collection from medical records was organized through an electronic structured data collection form by two of authors (H.S and N.S).
The abstraction documents included; patient's age, sex, family history, age at onset, type and side of motor symptoms onset, associated non-motor manifestations. Moreover; management plan, drug history, outcome and disease progression were also verified and recorded.
During medical record reviewing (MRR); any missing documentation or poorly recorded information was managed by deleting the case.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Parkinson Disease | – | – |
| Other Parkinsonian syndromes | – | – |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinsonian syndromes
Key inclusion criteria (1 listed)
- All patients with Parkinsonian syndromes
Key exclusion criteria (1 listed)
- Records with missing operationalized variables from patient records
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 to L-Dopa start
Time frame: 6 - 12 months
The time to L-Dopa start from symptoms onset in relation to time of Diagnosis
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 26 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Cairo University.
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 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: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
time to L-Dopa start (time frame: 6 - 12 months). 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 26 Dec 2017.