Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

Parkinson's Disease Clinical Trial

Official title:

Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02785510
• Other study ID #: Egy Neuro 1 study
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2016
• Last updated: October 8, 2017
• Start date: August 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2017
• Source: Zagazig University
• Contact: Ahmed S Negida
• Phone: +20 1125549087
• Email: ahmed01251[@]medicine.zu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Egypt	National Liver Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Blin P, Dureau-Pournin C, Foubert-Samier A, Grolleau A, Corbillon E, Jové J, Lassalle R, Robinson P, Poutignat N, Droz-Perroteau C, Moore N. Parkinson's disease incidence and prevalence assessment in France using the national healthcare insurance database. Eur J Neurol. 2015 Mar;22(3):464-71. doi: 10.1111/ene.12592. Epub 2014 Nov 12. — View Citation

Ceravolo R, Frosini D, Rossi C, Bonuccelli U. Impulse control disorders in Parkinson's disease: definition, epidemiology, risk factors, neurobiology and management. Parkinsonism Relat Disord. 2009 Dec;15 Suppl 4:S111-5. doi: 10.1016/S1353-8020(09)70847-8. Review. — View Citation

Douglas MR. Gene therapy for Parkinson's disease: state-of-the-art treatments for neurodegenerative disease. Expert Rev Neurother. 2013 Jun;13(6):695-705. doi: 10.1586/ern.13.58. Review. — View Citation

Durmus H, Gokalp MA, Hanagasi HA. Prevalence of Parkinson's disease in Baskale, Turkey: a population based study. Neurol Sci. 2015 Mar;36(3):411-3. doi: 10.1007/s10072-014-1988-x. Epub 2014 Oct 29. — View Citation

Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, Van Hilten JJ, LaPelle N. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Mov Disord. 2007 Jan;22(1):41-7. — View Citation

Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. — View Citation

Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045. Review. — View Citation

Liu WM, Wu RM, Lin JW, Liu YC, Chang CH, Lin CH. Time trends in the prevalence and incidence of Parkinson's disease in Taiwan: A nationwide, population-based study. J Formos Med Assoc. 2016 Jul;115(7):531-8. doi: 10.1016/j.jfma.2015.05.014. Epub 2015 Jun 27. — View Citation

Obeso JA, Rodríguez-Oroz MC, Benitez-Temino B, Blesa FJ, Guridi J, Marin C, Rodriguez M. Functional organization of the basal ganglia: therapeutic implications for Parkinson's disease. Mov Disord. 2008;23 Suppl 3:S548-59. doi: 10.1002/mds.22062. Review. — View Citation

Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28. Review. — View Citation

Van Den Eeden SK, Tanner CM, Bernstein AL, Fross RD, Leimpeter A, Bloch DA, Nelson LM. Incidence of Parkinson's disease: variation by age, gender, and race/ethnicity. Am J Epidemiol. 2003 Jun 1;157(11):1015-22. — View Citation

Wang G, Li XJ, Hu YS, Cheng Q, Wang CF, Xiao Q, Liu J, Ma JF, Zhou HY, Pan J, Tan YY, Wang Y, Chen SD. Mortality from Parkinson's disease in China: Findings from a five-year follow up study in Shanghai. Can J Neurol Sci. 2015 Jul;42(4):242-7. doi: 10.1017/cjn.2015.49. — View Citation

Wright Willis A, Evanoff BA, Lian M, Criswell SR, Racette BA. Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries. Neuroepidemiology. 2010;34(3):143-51. doi: 10.1159/000275491. Epub 2010 Jan 15. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age at disease onset	Patients age when the initial symptom appeared.	At enrolment
Primary	Time to diagnosis	Duration, in years, from appearance of initial symptom to receiving Parkinson's disease diagnosis.	At enrolment
Primary	Initial motor symptom	Number of patients with each initial motor symptom (tremor, rigidity, or bradykinesia).	At enrolment
Primary	Side of initial motor symptoms	Number of patients with either right or left side initial motor symptoms.	At enrolment
Primary	Clinical subtype of the disease	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).	At enrolment
Primary	Duration of levodopa treatment from disease onset	Number of years on levodopa treatment since receiving parkinson's disease diagnosis	At enrolment
Primary	Levodopa equivalent dose	Current dose of levodopa per day	At enrolment
Primary	Non-motor symptoms	Non-motor symptoms measured by the non-motor symptoms questionnaire (NMS)	At enrolment
Primary	Quality of life	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).	At enrolment
Secondary	Stage of the disease [optional]	The stage of the disease (stage 1, stage 2, stage 3, or stage 4) according to Hoehn and Yahr classification.	At enrolment
Secondary	Motor Functions [optional]	Motor functions assessed by the third part of the unified parkinson's disease rating scale (UPDRS III).	At enrolment

External Links

•   Study Website