Evaluation of the efficacy of Methylphenidate and modafinil in the treatment of excessive daily sleepiness in patients with drug-resistant epilepsy and comparison with the control group
Evaluation of the efficacy of Methylphenidate and Modafinil in the treatment of excessive daily sleepiness in patients with drug-resistant epilepsy and comparison with the control group
Design
A clinical trial with a parallel group and control group, double-blind, randomized
Settings and conduct
In this study, a history of patients with refractory epilepsy who have been referred to the hospital clinic for EDS complaints is selected and patients who meet the inclusion criteria are selected. EDS diagnosis is also performed using the EPWORTH sleepiness scale form. Patients are randomly divided into three groups. The first group is treated with methylphenidate, the second group is treated with modafinil and the third group is untreated for 8 weeks. The dose of methylphenidate will be 10-20-day / mg. Patients will also be treated with modafinil at a dose of 200–600 mg / day. Patients will be re-evaluated after the course of treatment by the EPWORTH sleepiness scale and the rate of recovery will be monitored.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with refractory epilepsy; Diagnosis of EDS by a neurologist; Hypersensitivity to methylphenidate and modafinil; Individual consent to participate in the study; Exclusion criteria: Head trauma; Diagnosis of other neurologic diseases such as dementia; Stroke; Thyroid diseases; Drug abuse; Liver or kidney failure
Intervention groups
The first group is treated with methylphenidate, the second group is treated with modafinil and the third group is untreated for 8 weeks.
Main outcome variables
The amount of drowsiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N22
Registration date:2019-10-18, 1398/07/26
Registration timing:prospective
Last update:2019-10-18, 1398/07/26
Update count:0
Registration date
2019-10-18, 1398/07/26
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-25, 1398/08/03
Expected recruitment end date
2019-12-24, 1398/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Methylphenidate and modafinil in the treatment of excessive daily sleepiness in patients with drug-resistant epilepsy and comparison with the control group
Public title
Evaluation of the efficacy of Methylphenidate and modafinil in the treatment of excessive daily sleepiness in patients with drug-resistant epilepsy and comparison with the control group
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with refractory epilepsy
Diagnosis of EDS by a neurologist
Hypersensitivity to methylphenidate and modafinil
Individual consent to participate in the study
Exclusion criteria:
Head trauma
Diagnosis of other neurologic diseases such as dementia
stroke
Thyroid diseases
Drug abuse
Liver or kidney failure
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample was randomly divided into three groups of 28 each with a selection of closed envelopes. Each envelope containing one of the three labels A, B and C represented one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs were placed in envelopes in packages A and B without labeling and without the knowledge of the investigator.
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
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.MUI.MED.REC.1398.327
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
The amount of drowsiness
Timepoint
Before and after treatment
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group will be treated with methylphenidate at 10-20-day / mg.
Category
Treatment - Drugs
2
Description
Intervention group: Group II treated with modafinil at a dose of 200–600 mg / day
Category
Treatment - Drugs
3
Description
Control group: The control group will be untreated for 8 weeks.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Mohammadreza Najafi
Street address
Sofe Blvd, Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 5555
Email
najafi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
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
Mohammadreza Najafi
Position
Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosciences Research Center, Al-Zahra Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 5555
Email
najafi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Najafi
Position
Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosciences Research Center, Al-Zahra Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 5555
Email
najafi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Najafi
Position
Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosciences Research Center, Al-Zahra Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 5555
Email
najafi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is 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
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Al-Zahra Hospital
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.