Evaluation of Atomoxetine efficacy on Freezing of gait in patient with Parkinson referred to Ahvaz golestan hospital in a period six month in 2021
Design
A total of 32 patients of both sexes and all age groups will be randomly selected from Parkinson's patients referred to Ahvaz Golestan Hospital in a period of 6 months in 1400 who had frozen gait. Group A includes 16 patients, which an uninformed person randomly selected.
Settings and conduct
Blinding will be done by recording atomoxetine and placebo by a person who has no information about the patient group. Thirty-two Parkinson's patients referred to Golestan Hospital in Ahvaz for a period of 6 months in 1400 who suffered from frozen gait were randomly selected by an uninformed person and treated with atomoxetine at a dose of 40 mg for 2 weeks and then Dose increases to 80 mg for six weeks.
Participants/Inclusion and exclusion criteria
Entry
1. Diagnosis of Parkinson's disease based on examination and history 2. Patients with stage 2-4 of Hoehn and yahr scale; 3. Normal tests (vitamin B12, thyroid, liver and kidney tests) 4. Levodopa treatment for at least 3 months before the study 5. Ability to walk at least 20 steps without the use of assistive devices
No entry
1. Continued use of stimulants (STIMULANT)
2. Contraindications to the use of atomoxetine
Intervention groups
Patient with Parkinson referred to Ahvaz Golestan hospital
Main outcome variables
Age; Gender; Duration of illness; drug side effects; Follow-up time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211008052695N1
Registration date:2021-11-17, 1400/08/26
Registration timing:registered_while_recruiting
Last update:2021-11-17, 1400/08/26
Update count:0
Registration date
2021-11-17, 1400/08/26
Registrant information
Name
Esmat Ramezanirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3441 0975
Email address
d.r.ramezanirad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Atomoxetine efficacy on Freezing of gait in patient with Parkinson
Public title
Evaluation of Atomoxetine efficacy on Freezing of gait in patient with Parkinson
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Diagnosis of Parkinson's disease based on examination and history 2) Patients with stage 2-4 of Hoehn and yahr scale; 3) Normal tests (vitamin B12, thyroid, liver, and kidney tests) 4) Levodopa treatment for at least 3 months before the study 5) Ability to walk at least 20 steps without the use of assistive devices
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized controlled clinical trial. In this study, patients will be assigned to each treatment group using a randomized block method using four blocks in this study. Blocking is used to balance the number of samples assigned to each of the study groups. This feature helps to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The blinding method will also be used to prevent the allocation from being disclosed in each block. This study will be double-blind. The correction will be performed by recording atomoxetine and placebo by a person who has no information about the patient group. A total of 32 patients of both sexes and all age groups were randomly selected from Parkinson's patients referred to Ahvaz Golestan Hospital in 6 months in 1400 who had frozen gait and were treated with levodopa. Hoehn and yahr scale divisions in groups 2 to 4 will be included in the study. Group A consists of 16 patients randomly selected by an uninformed person and treated with atomoxetine 40 mg for two weeks and then increased the dose to 80 mg for six weeks.
Group B consists of 16 patients who are randomly selected by an uninformed person and are treated with a placebo similar to group A.
The first visit will be on the first day before starting treatment and determining the score of the FOGQ questionnaire and starting the medication. This questionnaire consists of 6 questions, each of which receives a score of 0 to 4, and the minimum score is 0, and the maximum is 24. The second visit will take place two weeks after treatment, and the third visit will take place six weeks after the second visit. The score of the FOGQ questionnaire will be prepared from the patient, and finally, the data will be analyzed by SPSS statistical software version 22.
The FOGQ questionnaire is a questionnaire that assesses the freezing of gait in Parkinson's patients. Giladi introduced this questionnaire in 1999. Giladi calculated the validity and reliability of this questionnaire on 40 patients with Parkinson's disease. Using Cronbach's alpha, 94% was obtained, and the validity rate for this questionnaire was 70% (Giladi article reference).
In Iran, this questionnaire was translated by Taghizadeh in 2021. He used the questionnaire for 115 patients with Parkinson's disease. Cronbach's alpha was 92% (Taghizadeh article).
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done by recording atomoxetine and placebo by a person who has no information about the patient group. A total of 32 patients of both sexes and all age groups were randomly selected from Parkinson's patients referred to Ahvaz Golestan Hospital in a period of 6 months in 1400 who had frozen gait and were treated with levodopa. The Hoehn and yahr scale divisions in categories 2 to 4 will be included in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Golestan Hospital
Street address
No. 9, 9 Resalat Ave., NIDC Complex
City
ahwaz
Province
Khouzestan
Postal code
6166648791
Approval date
2021-04-13, 1400/01/24
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.026
Health conditions studied
1
Description of health condition studied
Parkinson disease
ICD-10 code
G21.9
ICD-10 code description
Secondary parkinsonism, unspecified
Primary outcomes
1
Description
Freezing of gait in patient with Parkinson
Timepoint
Patients are treated with atomoxetine at a dose of 40 mg for 2 weeks and then increase the dose to 80 mg for six weeks.
Method of measurement
The first visit will be on the first day and before starting treatment, determining the FOGQ questionnaire's score, and starting the medication. This questionnaire consists of 6 questions, each of which receives a score of 0 to 4, and the minimum score is 0, and the maximum is 24. The second visit will take place two weeks after the start of treatment, and the third visit will take place 6 weeks after the second visit.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A includes 16 patients randomly selected by an uninformed person and treated with atomoxetine 40 mg for 2 weeks and then increase the dose to 80 mg for six weeks.
Category
Treatment - Drugs
2
Description
Control group: Group B includes 16 patients who are randomly selected by an uninformed person and are treated with a placebo similar to group A.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Golestan Hospital
Full name of responsible person
Seyed Ehsan Mohamadianinejad
Street address
No. 9, 9 Resalat Ave., NIDC Complex
City
Ahwaz
Province
Khouzestan
Postal code
6166648791
Phone
+98 61 3441 0975
Email
d.r.ramezanirad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohamadianinejad
Street address
Farvardin Ave., Golestan Hospital., Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6136763316
Phone
+98 61 3320 4531
Email
D.R.ramezanirad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohamadianinejad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Farvardin Ave., Golestan Hospital., Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6136763316
Phone
+98 61 3320 4531
Email
D.R.ramezanirad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohamadianinejad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Farvardin Ave., Golestan Hospital., Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6136763316
Phone
+98 61 3441 0975
Email
D.R.ramezanirad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohamadianinejad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Farvardin Ave., Golestan Hospital., Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6136763316
Phone
+98 61 3441 0975
Email
d.r.ramezanirad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After the analysis, the study results are presented to all study participants in the form of a file.
When the data will become available and for how long
Start of the access period from the end of 1400 for 6 months after the end of printing the results
To whom data/document is available
Researchers and participants
Under which criteria data/document could be used
Access to the data is not an obstacle if the participants' personal details are distorted.
From where data/document is obtainable
Responsible person - 09163439107
What processes are involved for a request to access data/document
Contact the project manager - review the application - register and submit