Determining and comparing the mean changes of Epworth score after the intervention compared to before the intervention between the two groups of methylphenidate and medafinil
Determining and comparing all the side effects reported during the study and comparing the rate of side effects between the two groups of medafinil or methylphenidate
Design
Clinical trial with 2 parallel randomized groups, double blinded, each group including 30 patients, Random allocation software was used for randomization.
Settings and conduct
The study will be performed on 60 patients with Parkinson's sisease who are randomly assigned to the medafinil or methylphenidate group. The study location is Isfahan University of Medical Sciences in Al-Zahra and Kashani Hospital in 1401. The study is double blinded. The two random groups are parallel. Blinding is done using randomly numbered drug containers. Participants, outcome checkers, observers, researchers, and data analyzers are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with Parkinson's disease.
2- Diagnosis of excessive daytime sleepiness by a neurologist
3-Insensitivity to modafinil or methylphenidate
4- The patient's consent to participate in the study
Exclusion criteria:
1- Patient's dissatisfaction of participating in the study
2- History of head trauma
3- Diagnosis of other neurological diseases such as dementia
4- Stroke
5- Thyroid diseases
6- Substance abuser
7- Liver or kidney failure
8- Heart disease
9- History of psychiatric illness who is being treated with psychiatric drugs.
10- Taking hypnotics
11- Patient illiteracy
Intervention groups
One group is treated with medafinil and one group is treated with methylphenidate.
Main outcome variables
Evaluation of daily sleepiness using Epworth questionnaire before and after the intervention and recording of all side effects observed during the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220623055257N1
Registration date:2022-06-27, 1401/04/06
Registration timing:prospective
Last update:2022-06-27, 1401/04/06
Update count:0
Registration date
2022-06-27, 1401/04/06
Registrant information
Name
Farzaneh Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3071
Email address
fh1390i@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness of Modafinil and methylphenidate in treatment of excessive daytime sleepiness in patients with Parkinson disease
Public title
comparison of the effectiveness of Modafinil and methylphenidate in treatment of excessive daytime sleepiness in patients with Parkinson disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who have Parkinson disease
diagnosis of excessive daytime sleepiness(EDS) by neurologist
not having sensitivity to Modafinil or Methylphenidate
Individual consent to participate in the study
Exclusion criteria:
Dissatisfaction of the patient to continue participating in the study
history of head trauma
diagnosis of other neurological disease such as Dementia
thyroid disorder
history of CVA
drug abuser
kidney or liver failure
heart disease
History of a psychiatric illness being treated with psychiatric medication
Taking hypnotics
being illiterate
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants, clinicians, researchers, outcome evaluators, and data analysts do not know whether the patient is in the medafinil group or methylphenidate. The participant knows that he / she will be in one of these two groups, but the type of group is according to randomization methods. 60 patients are divided into two equal groups of 30 people according to random numbers generated by Random Allocation Software.The drug partner provides us with 60 boxes of exactly the same shape and weight that contain modafinil or methylphenidate. These drugs also look exactly the same, and these boxes are available to the participant according to random numbers produced by the software. At the end of the complete data analysis, our drug partner informs us what medicine each box contains.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, clinicians, researchers, outcome evaluators, and data analysts do not know whether the patient is in the medafinil group or methylphenidate. The participant knows that he will be in one of these two groups, but the type of group depends on the methods of randomization.Each participant receives a box containing methylphenidate or modafinil. These two types of boxes are completely similar in appearance. The method of allocating the box is according to numbers generated by randomization software.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St., Ethics Committee of Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-04-23, 1401/02/03
Ethics committee reference number
IR.MUI.MED.REC.1401.030
Health conditions studied
1
Description of health condition studied
Daily-time sleepiness in patients with Parkinson's
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Daily sleepiness in patients with Parkinson's
Timepoint
Beginning of study and 8 weeks later
Method of measurement
Epworth Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients with Parkinson's disease who are treated with medafinil at a dose of 200 mg daily for 8 weeks to treat daily drowsiness.
Category
Treatment - Drugs
2
Description
Intervention group: 30 patients with Parkinson's disease who are treated with methylphenidate at a dose of 10 mg daily for 8 weeks to treat daily drowsiness.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital Clinic
Full name of responsible person
Farzaneh Habibi
Street address
Soffe Boulevard
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3071
Email
fh1390i@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Keyvan Basiri
Street address
Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3071
Email
fh1390i@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Farzaneh Habibi
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Hezar Jarib Ave, Isfahan university of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3071
Fax
Email
fh1390i@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farzaneh Habibi
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Hezar Jarib Ave, Isfahan university of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3071
Fax
Email
fh1390i@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farzaneh Habibi
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Hezar Jarib Ave, Isfahan university of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3071
Fax
Email
fh1390i@yahoo.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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data of study participants
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic, scientific institutes