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Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 by Zagazig University
Sponsor:
Information provided by (Responsible Party):
Ahmed Negida, Zagazig University
ClinicalTrials.gov Identifier:
NCT02785510
First received: May 22, 2016
Last updated: May 24, 2016
Last verified: May 2016
  Purpose
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
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

Resource links provided by NLM:


Further study details as provided by Zagazig University:

Primary Outcome Measures:
  • Age at disease onset [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    Patients age when the initial symptom appeared.

  • Time to diagnosis [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    Duration, in years, from appearance of initial symptom to receiving Parkinson's disease diagnosis.

  • Initial motor symptom [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    Number of patients with each initial motor symptom (tremor, rigidity, or bradykinesia).

  • Side of initial motor symptoms [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    Number of patients with either right or left side initial motor symptoms.

  • Clinical subtype of the disease [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    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).

  • Pattern of levodopa treatment [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    Levodopa equivalent dose per day and duration of levodopa treatment from disease onset

  • Non-motor symptoms [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    Non-motor symptoms measured by the non-motor symptoms questionnaire (NMS)

  • Quality of life [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    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:
  • Stage of the disease [optional] [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    The stage of the disease (stage 1, stage 2, stage 3, or stage 4) according to Hoehn and Yahr classification.

  • Motor Functions [optional] [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    Motor functions assessed by the third part of the unified parkinson's disease rating scale (UPDRS III).


Estimated Enrollment: 500
Study Start Date: January 2017
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who meet the diagnosis of Parkinson's disease according to the Parkinson's disease criteria of United Kingdom Brain Bank.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02785510

Contacts
Contact: Ahmed S Negida +20 1125549087 ahmed01251@medicine.zu.edu.eg

Sponsors and Collaborators
Zagazig University
  More Information

Additional 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     History of Changes
Other Study ID Numbers: Egy Neuro 1 study 
Study First Received: May 22, 2016
Last Updated: May 24, 2016
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on May 26, 2016