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Clinical Trials/NCT02785510
NCT02785510
Unknown
Not Applicable

Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

Zagazig University1 site in 1 country500 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Zagazig University
Enrollment
500
Locations
1
Primary Endpoint
Non-motor symptoms
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
December 31, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Eligibility 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)

Outcomes

Primary Outcomes

Non-motor symptoms

Time Frame: At enrolment

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

Side of initial motor symptoms

Time Frame: At enrolment

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

Levodopa equivalent dose

Time Frame: At enrolment

Current dose of levodopa per day

Time to diagnosis

Time Frame: At enrolment

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

Initial motor symptom

Time Frame: At enrolment

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

Quality of life

Time Frame: 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

Time Frame: At enrolment

Patients age when the initial symptom appeared.

Clinical subtype of the disease

Time Frame: 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

Time Frame: At enrolment

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

Secondary Outcomes

  • Stage of the disease [optional](At enrolment)
  • Motor Functions [optional](At enrolment)

Study Sites (1)

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