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IRCT20220623055257N1 IRCT 2022-06-27 Esfahan University of Medical Sciences comparison of the effectiveness of Modafinil and methylphenidate in treatment of excessive daytime sleepiness in patients with Parkinson disease comparison of the effectiveness of Modafinil and methylphenidate in treatment of excessive daytime sleepiness in patients with Parkinson disease 2022-08-23 anticipated 60 Complete https://irct.ir/trial/64415 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Daily-time sleepiness in patients with Parkinson's. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Individual data of study participants When: Access period starts 6 months after the results are published To whom: Researchers working in academic, scientific institutes Conditions: Using data for review articles Where to obtain: Researcher email address Farzaneh Habibi : fh1390i@yahoo.com How to obtain: Check the individual dependence on the university center Comments:
public Farzaneh Habibi
Hezar Jarib Ave, Isfahan university of Medical Sciences
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3071 fh1390i@yahoo.com Esfahan University of Medical Sciences scientific Farzaneh Habibi
Hezar Jarib Ave, Isfahan university of Medical Sciences
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3071 fh1390i@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both 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 G20 Parkinson's disease Treatment - Drugs Treatment - Drugs 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. 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. Daily sleepiness in patients with Parkinson's. Timepoint: Beginning of study and 8 weeks later. Method of measurement: Epworth Questionnaire. Esfahan University of Medical Sciences Approved 2022-04-23 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib St., Ethics Committee of Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)