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Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

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ClinicalTrials.gov Identifier: NCT02785510
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Negida, 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.

Condition or disease
Parkinson's Disease

Study Type : Observational
Estimated 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 : August 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Age at disease onset [ Time Frame: At enrolment ]
    Patients age when the initial symptom appeared.

  2. Time to diagnosis [ Time Frame: At enrolment ]
    Duration, in years, from appearance of initial symptom to receiving Parkinson's disease diagnosis.

  3. Initial motor symptom [ Time Frame: At enrolment ]
    Number of patients with each initial motor symptom (tremor, rigidity, or bradykinesia).

  4. Side of initial motor symptoms [ Time Frame: At enrolment ]
    Number of patients with either right or left side initial motor symptoms.

  5. 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).

  6. Duration of levodopa treatment from disease onset [ Time Frame: At enrolment ]
    Number of years on levodopa treatment since receiving parkinson's disease diagnosis

  7. Levodopa equivalent dose [ Time Frame: At enrolment ]
    Current dose of levodopa per day

  8. Non-motor symptoms [ Time Frame: At enrolment ]
    Non-motor symptoms measured by the non-motor symptoms questionnaire (NMS)

  9. 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).


Secondary Outcome Measures :
  1. Stage of the disease [optional] [ Time Frame: 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] [ Time Frame: At enrolment ]
    Motor functions assessed by the third part of the unified parkinson's disease rating scale (UPDRS III).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785510


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

Locations
Egypt
National Liver Institute Recruiting
Cairo, Egypt
Contact: Samah A Loutfy, PhD       samaly183@yahoo.com   
Sponsors and Collaborators
Zagazig University

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
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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