NCT02785510

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

May 22, 2016

Last Update Submit

October 8, 2017

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (9)

  • Age at disease onset

    Patients age when the initial symptom appeared.

    At enrolment

  • Time to diagnosis

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

    At enrolment

  • Initial motor symptom

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

    At enrolment

  • Side of initial motor symptoms

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

    At enrolment

  • 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

  • Duration of levodopa treatment from disease onset

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

    At enrolment

  • Levodopa equivalent dose

    Current dose of levodopa per day

    At enrolment

  • Non-motor symptoms

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

    At enrolment

  • 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 Outcomes (2)

  • Stage of the disease [optional]

    At enrolment

  • Motor Functions [optional]

    At enrolment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients who meet the Parkinson's disease criteria of United Kingdom Brain Bank within the study centres.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Liver Institute

Cairo, Egypt

RECRUITING

Related Publications (14)

  • Obeso JA, Rodriguez-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.

    PMID: 18781672BACKGROUND

  • 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.

    PMID: 20123548BACKGROUND

  • Blin P, Dureau-Pournin C, Foubert-Samier A, Grolleau A, Corbillon E, Jove 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.

    PMID: 25389031BACKGROUND

  • 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.

    PMID: 25351343BACKGROUND

  • 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. doi: 10.1093/aje/kwg068.

    PMID: 12777365BACKGROUND

  • 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. doi: 10.1002/mds.21198.

    PMID: 17115387BACKGROUND

  • 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. doi: 10.1136/jnnp.55.3.181.

    PMID: 1564476BACKGROUND

  • 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.

    PMID: 18344392BACKGROUND

  • 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.

    PMID: 26123636BACKGROUND

  • 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.

    PMID: 24976103BACKGROUND

  • 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.

    PMID: 23739006BACKGROUND

  • 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.

    PMID: 26153040BACKGROUND

  • 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.

    PMID: 20090375BACKGROUND

  • Shaheen M, Mokarrab M, Youssef A, Aref M, Abushouk AI, Elmaraezy A, Almasswary A. Physiological evaluation of the provisional side-branch intervention strategy for bifurcation lesions using instantaneous wave-free ratio. Indian Heart J. 2018 Dec;70 Suppl 3(Suppl 3):S254-S258. doi: 10.1016/j.ihj.2018.01.028. Epub 2018 Jan 31.

    PMID: 30595269DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Ahmed S Negida

CONTACT

+20 1125549087ahmed01251@medicine.zu.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
(1) Principal Investigator; (2) Head of Scientific Committee, Student Research Unit, Zagazig University; and (3) Head of Scientific Committee, Egyptian National Research Collaborative.

Study Record Dates

First Submitted

May 22, 2016

First Posted

May 27, 2016

Study Start

August 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 10, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

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.

Locations

EG(1)