NCT03420573

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

January 29, 2018

Last Update Submit

January 29, 2018

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Score of UPDRS

    Severity of Motor and non motor symptoms

    2 years

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's Disease patients with hepatitis C infection

You may qualify if:

  • Patient with history of Parkinson's Disease and Hepatitis C infection.

You may not qualify if:

  • Advanced liver cirrhosis.
  • Patients with hepatic failure.
  • Symptoms of Parkinson's plus syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28356465BACKGROUND

  • Kim 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.

    PMID: 27549922BACKGROUND

  • Golabi 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.

    PMID: 28425403BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Shaimaa I. El-Jaafary, MD

    Director of Kasr Alainy Movement Disorders Unit KAMDU

    STUDY DIRECTOR

Central Study Contacts

Shaimaa I. El-Jaafary, MD

CONTACT

+2 01119213915shaimaa_jafary@kasralainy.edu.eg

Hanan A. Amer, MD

CONTACT

hanan.amer@kasralainy.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Neurology

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Study Start

March 1, 2018

Primary Completion

October 1, 2019

Study Completion

March 1, 2020

Last Updated

February 5, 2018

Record last verified: 2018-01