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Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

Sponsor
Zagazig University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02785510
Collaborator
(none)
500
Enrollment
1
Location
17
Anticipated Duration (Months)
29.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Parkinson's disease is the second most common neurodegenerative disease affecting about 1-3% of population above 60 years. Recently, non-motor symptoms are getting more attention in PD management. The pattern of PD onset and clinical course differ from one population to another. Many studies have been conducted to determine the clinical profile of PD in populations worldwide. However, no similar studies have been conducted in Egypt. Therefore, the investigators will conduct a nation-wide, collaborative, cross sectional study to determine the pattern of Parkinson's disease onset, clinical course, and non-motor symptoms among Egyptian population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Determining Clinical Profile of Parkinson's Disease Among Egyptian Population
    Actual Study Start Date :
    Aug 1, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2018
    Anticipated Study Completion Date :
    Dec 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Age at disease onset [At enrolment]

      Patients age when the initial symptom appeared.

    2. Time to diagnosis [At enrolment]

      Duration, in years, from appearance of initial symptom to receiving Parkinson's disease diagnosis.

    3. Initial motor symptom [At enrolment]

      Number of patients with each initial motor symptom (tremor, rigidity, or bradykinesia).

    4. Side of initial motor symptoms [At enrolment]

      Number of patients with either right or left side initial motor symptoms.

    5. Clinical subtype of the disease [At enrolment]

      Number patients with each disease subtype (tremor dominant Parkinson's disease, hypokinetic-rigid dominant Parkinson's disease, or postural instability and gait disturbance dominant Parkinson's disease).

    6. Duration of levodopa treatment from disease onset [At enrolment]

      Number of years on levodopa treatment since receiving parkinson's disease diagnosis

    7. Levodopa equivalent dose [At enrolment]

      Current dose of levodopa per day

    8. Non-motor symptoms [At enrolment]

      Non-motor symptoms measured by the non-motor symptoms questionnaire (NMS)

    9. Quality of life [At enrolment]

      Mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort assessed by the parkinson's disease quality of life questionnaire (PDQ-39).

    Secondary Outcome Measures

    1. Stage of the disease [optional] [At enrolment]

      The stage of the disease (stage 1, stage 2, stage 3, or stage 4) according to Hoehn and Yahr classification.

    2. Motor Functions [optional] [At enrolment]

      Motor functions assessed by the third part of the unified parkinson's disease rating scale (UPDRS III).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who meet the Parkinson's disease criteria of United Kingdom Brain Bank within the study centres.
    Exclusion Criteria:

    • Patients with vascular Parkinsonism (history of stroke)

    • Patients with treatment induced Parkinsonism

    • Patients with history of dopaminergic neurotoxin (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Liver Institute Cairo Egypt

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Negida, (1) Principal Investigator; (2) Head of Scientific Committee, Student Research Unit, Zagazig University; and (3) Head of Scientific Committee, Egyptian National Research Collaborative., Zagazig University
    ClinicalTrials.gov Identifier:
    NCT02785510
    Other Study ID Numbers:
    • Egy Neuro 1 study
    First Posted:
    May 27, 2016
    Last Update Posted:
    Oct 10, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Oct 10, 2017