Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

• Conditions: Parkinson's Disease

• Registration Number: NCT02785510
• Lead Sponsor: Zagazig University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-22
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Study Start: 2017-08-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-08
• Last Update Posted: 2017-10-10
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Side of initial motor symptoms	At enrolment	Number of patients with either right or left side initial motor symptoms.
Levodopa equivalent dose	At enrolment	Current dose of levodopa per day
Time to diagnosis	At enrolment	Duration, in years, from appearance of initial symptom to receiving Parkinson's disease diagnosis.
Initial motor symptom	At enrolment	Number of patients with each initial motor symptom (tremor, rigidity, or bradykinesia).
Non-motor symptoms	At enrolment	Non-motor symptoms measured by the non-motor symptoms questionnaire (NMS)
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).
Age at disease onset	At enrolment	Patients age when the initial symptom appeared.
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).
Duration of levodopa treatment from disease onset	At enrolment	Number of years on levodopa treatment since receiving parkinson's disease diagnosis

Secondary Outcome Measures

Name	Time	Method
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.
Motor Functions [optional]	At enrolment	Motor functions assessed by the third part of the unified parkinson's disease rating scale (UPDRS III).

Trial Locations

Locations (1)

National Liver Institute; 🇪🇬 Cairo, Egypt