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AzTrials

Parkinson's DiseaseNCT02785510

Determining Clinical Profile of Parkinson's Disease Among Egyptian Population

An observational study of Parkinson's Disease, run by Zagazig University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson's Disease
How many people
500 participants
Where
1 siteEgypt
Study dates
1 Aug 2017to 31 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who meet the diagnosis of Parkinson's disease according to the Parkinson's disease criteria of United Kingdom Brain Bank.

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Ahmed S Negida contact

+20 1125549087

ahmed01251@medicine.zu.edu.eg

Egypt1 site, 1 recruiting

  • National Liver Institute

    Cairo

    Samah A Loutfy, PhD, samaly183@yahoo.com

    Recruiting

Other trials in Egypt

About this study

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.

Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age at disease onset

    Patients age when the initial symptom appeared.

    Measured: At enrolment

  2. Time to diagnosis

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

    Measured: At enrolment

  3. Initial motor symptom

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

    Measured: At enrolment

  4. Side of initial motor symptoms

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

    Measured: At enrolment

  5. 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).

    Measured: At enrolment

  6. Duration of levodopa treatment from disease onset

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

    Measured: At enrolment

  7. Levodopa equivalent dose

    Current dose of levodopa per day

    Measured: At enrolment

  8. Non-motor symptoms

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

    Measured: At enrolment

  9. 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).

    Measured: At enrolment

Secondary outcomes (2)

  1. 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.

    Measured: At enrolment

  2. Motor Functions [optional]

    Motor functions assessed by the third part of the unified parkinson's disease rating scale (UPDRS III).

    Measured: At enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study start1 Aug 2017
  3. Primary completion31 Dec 2018 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02785510
Sponsor's protocol ID
Egy Neuro 1 study
Status last verified
Oct 2017
First submitted
22 May 2016
Last updated
10 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 18781672

  • 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.

    PubMed 20123548

  • 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.

    PubMed 25389031

  • 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.

    PubMed 25351343

  • 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.

    PubMed 12777365

  • 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.

    PubMed 17115387

  • 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.

    PubMed 1564476

  • 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.

    PubMed 18344392

  • 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.

    PubMed 26123636

  • 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.

    PubMed 24976103

  • 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.

    PubMed 23739006

  • 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.

    PubMed 26153040

  • 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.

    PubMed 20090375

  • 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.

    PubMed 30595269

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed S Negida (+20 1125549087, ahmed01251@medicine.zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age at disease onset (time frame: At enrolment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02785510, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.

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