Parkinson DiseaseNCT03420573
Clinical Profile of Parkinson's Disease in Patients With Hepatitis C Infection
An observational study of Parkinson Disease, run by Kasr El Aini Hospital.
Trial summary
There is association between Hepatitis C and Parkinson's Disease as shown from previous studies. The clinical profile and natural history is not fully studied yet. We aim at studying the clinical characteristics of Parkinson's Disease in patients with hepatitis C infection. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Mar 2020
- How long will I take part?
- 1 Year
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's Disease patients with hepatitis C infection
Who may be able to join
- Patient with history of Parkinson's Disease and Hepatitis C infection.
Who cannot join
- Advanced liver cirrhosis.
- Patients with hepatic failure.
- Symptoms of Parkinson's plus syndrome.
Trial locations and contacts
No sites are listed yet.
Hanan A. Amer, MD contact
About this study
There is association between Hepatitis C and Parkinson's Disease as shown from previous studies. The clinical profile and natural history is not fully studied yet. We aim at studying the clinical characteristics of Parkinson's Disease in patients with hepatitis C infection.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of UPDRS
Severity of Motor and non motor symptoms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startMar 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionMar 2020 (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.
- 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)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa El-Jaafary, Kasr El Aini Hospital
- Investigators
- Shaimaa I. El-Jaafary, MD, Study director, Director of Kasr Alainy Movement Disorders Unit KAMDU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420573
- Sponsor's protocol ID
- KAMDUPDHC
- Status last verified
- Jan 2018
- First submitted
- 29 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous Demographic data ,severity of symptoms, score results
Publications
Pakpoor J, Noyce A, Goldacre R, Selkihova M, Mullin S, Schrag A, Lees A, Goldacre M. Viral hepatitis and Parkinson disease: A national record-linkage study. Neurology. 2017 Apr 25;88(17):1630-1633. doi: 10.1212/WNL.0000000000003848. Epub 2017 Mar 29.
PubMed 28356465Kim JM, Jang ES, Ok K, Oh ES, Kim KJ, Jeon B, Jo HJ, Ki M, Jeong SH. Association between hepatitis C virus infection and Parkinson's disease. Mov Disord. 2016 Oct;31(10):1584-1585. doi: 10.1002/mds.26755. No abstract available.
PubMed 27549922Golabi P, Otgonsuren M, Sayiner M, Arsalla A, Gogoll T, Younossi ZM. The Prevalence of Parkinson Disease Among Patients With Hepatitis C Infection. Ann Hepatol. 2017 May-Jun;16(3):342-348. doi: 10.5604/16652681.1235476.
PubMed 28425403
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile of Parkinson's Disease in Patients With Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT03420573
- Acronym / sponsor ID
- KAMDUPDHC
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 5 Feb 2018 (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.
There is association between Hepatitis C and Parkinson's Disease as shown from previous studies. The clinical profile and natural history is not fully studied yet. We aim at studying the clinical characteristics of Parkinson's Disease in patients with hepatitis C infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's Disease patients with hepatitis C infection
Key inclusion criteria (1 listed)
- Patient with history of Parkinson's Disease and Hepatitis C infection.
Key exclusion criteria (3 listed)
- Advanced liver cirrhosis.
- Patients with hepatic failure.
- Symptoms of Parkinson's plus syndrome.
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
Score of UPDRS
Time frame: 2 years
Severity of Motor and non motor symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Background: PubMed 28356465Pakpoor J, Noyce A, Goldacre R, Selkihova M, Mullin S, Schrag A, Lees A, Goldacre M. Viral hepatitis and Parkinson disease: A national record-linkage study. Neurology. 2017 Apr 25;88(17):1630-1633. doi: 10.1212/WNL.0000000000003848. Epub 2017 Mar 29.
- Background: PubMed 27549922Kim JM, Jang ES, Ok K, Oh ES, Kim KJ, Jeon B, Jo HJ, Ki M, Jeong SH. Association between hepatitis C virus infection and Parkinson's disease. Mov Disord. 2016 Oct;31(10):1584-1585. doi: 10.1002/mds.26755. No abstract available.
- Background: PubMed 28425403Golabi P, Otgonsuren M, Sayiner M, Arsalla A, Gogoll T, Younossi ZM. The Prevalence of Parkinson Disease Among Patients With Hepatitis C Infection. Ann Hepatol. 2017 May-Jun;16(3):342-348. doi: 10.5604/16652681.1235476.
- Individual participant dataSharing planned: Undecided. Anonymous Demographic data ,severity of symptoms, score results
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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.
Hanan A. Amer, MD contact
Shaimaa I. El-Jaafary, MD study director
Director of Kasr Alainy Movement Disorders Unit KAMDU
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Kasr El Aini Hospital.
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: status not confirmed, as of the sponsor's last update on 5 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa I. El-Jaafary, MD (+2 01119213915, shaimaa_jafary@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of UPDRS (time frame: 2 years). 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 NCT03420573, 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 5 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.