UMIN-CTR Clinical Trial

Basic information
Public title	Palliative performance scale as a prognostic tool among Egyptian Parkinson's disease patients
Acronym	Palliative performance scale among Egyptian Parkinson's disease patients
Scientific Title	Palliative performance scale as a prognostic tool among Egyptian Parkinson's disease patients: a hospital based pilot study
Scientific Title:Acronym	Palliative performance scale among Egyptian Parkinson's disease patients
Region	Africa

Condition
Condition	Palliative performance scale
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We hypothesize that the PPS will be a potential predictor tool of disease progression among a sample of PD patients.
Basic objectives2	Others
Basic objectives -Others	predictor tool
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	change in clinical motor scales including H & Y scale and/or UPDRS (Part III and/or Total score) over time (6-month duration)
Key secondary outcomes	change in PPS score over time

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	Egyptian patients diagnosed with IPD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria
Key exclusion criteria	Vascular PD (VP) Parkinson plus syndrome (PPS) patients cognitive impaired patients (MMSE=24 or abnormal for education level) patients with negative levodopa challenge test wheelchair bound or bed ridden patients, and severely disabled patients with Hoehn and Yahr scale (H & Y) stage 4 or 5
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Wael Middle name Last name Ibrahim
Organization	Kasralainy hospital, Faculty of medicine, Cairo University; Egypt
Division name	Neurology
Zip code	11562
Address	Cairo
TEL	+201111919927
Email	dr.wael_ezzat@residents.kasralainy.edu.eg

Public contact
1st name of contact person	1st name Wael Middle name Last name Wael Ibrahim
Organization	Kasralainy hospital, Faculty of Medicine, Cairo University
Division name	Neurology
Zip code	12411
Address	37 elhassan street, dokki
TEL	+201111919927
Homepage URL
Email	dr.wael_ezzat@yahoo.com

Sponsor
Institute	Kasralainy hospital, Faculty of medicine, Cairo University; Egypt
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	scientific & ethical committee of neurology department, faculty of medicine, Cairo university
Address	Kasr Al Ainy St. Cairo, Egypt
Tel	(202)23682030
Email	Admin@kasralainy.edu.eg

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2019 Year 04 Month 01 Day
Anticipated trial start date	2019 Year 05 Month 01 Day
Last follow-up date	2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	pilot prospective Cohort involving a sample of Egyptian PD patients at Kasralainy hospital, Cairo university

Management information
Registered date	2019 Year 04 Month 25 Day
Last modified on	2019 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041503