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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

May 22, 2016
May 24, 2016
January 2017
June 2017   (final data collection date for primary outcome measure)
  • 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).
Same as current
No Changes Posted
  • 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).
Same as current
Not Provided
Not Provided
 
Determining Clinical Profile of Parkinson's Disease Among Egyptian Population
Determining Clinical Profile of Parkinson's Disease Among Egyptian Population
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Patients who meet the diagnosis of Parkinson's disease according to the Parkinson's disease criteria of United Kingdom Brain Bank.
Parkinson's Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
500
August 2017
June 2017   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact: Ahmed S Negida +20 1125549087 ahmed01251@medicine.zu.edu.eg
Not Provided
 
NCT02785510
Egy Neuro 1 study
No
Yes
All data will be collected on a secure database (REDCap of Al-Azhar University). Investigators, who want to share a part of the whole of the patient data, should submit a request to our website (http://emra-collaborative.org/contact.html). They will enter in a data sharing agreement with the Egyptian National Research Collaborative to ensure proper acknowledgement of all study collaborators as non-author contributors in secondary publications from these data.
Ahmed Negida, Zagazig University
Zagazig University
Not Provided
Not Provided
Zagazig University
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP