Multiple sclerosis related fatigue. Multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group: 26 patients in this group are treated for 2 months with lisdexamfetamine manufactured by Tadbir Kalaye Jam Company. The starting dose is 30 mg daily for one month.
Sponsors
Tehran University of Medical Sciences
Research Center for Rational Use of Drugs
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Definitive diagnosis of MS based on 2017 McDonald criteria Age 18 to 45 years Informed and written consent of the patient EDSS=5.5 Total score obtained from MFIS greater than 33 Not changing the type or dose of DMT in the last three months
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding Allergy to the drug or formulation ingredients Severe renal failure (ClCr < 30 ml/min/1.73m2) moderate to severe liver failure (Child Pugh B, C) history of attack or receiving pulse dose of corticosteroid in the last one month or during the study Changing the used medication during the study Abuse of alcohol and drugs such as opium or psychoactive agents simultaneous use or last two weeks use of amantadine, modafinil, methylphenidate, dexamphetamine suffering from any untreated thyroid disorder (TSH outside the normal range) Vitamin D level less than 20 ng/ml A patient with anemia (hemoglobin less than 14 g/dL in men or less than 12 g/dL in women) Patients who suffer from severe fatigue and need symptomatic treatment due to ethical considerations History of cardiovascular or cerebrovascular disease such as IHD, ACS, heart failure, any cerebral ischemia and bleeding, and uncontrolled blood pressure (SBP =160 or DBP =100) Concurrently suffering from any anxiety disorder, severe depression or psychosis for which they are receiving pharmacotherapy History or simultaneous suffering from epilepsy Taking monoamine oxidase inhibitors in the last 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue score in MFIS questionnaire. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: MFIS questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: blood pressure monitor.;Heart rate. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: heart rate monitor.;Weight. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: scale.;Anxiety score. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: Hamilton Anxiety Rating Scale.;Sleep quality score. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: Pittsburgh Sleep Quality Index.;Depression score. Timepoint: beginning of the study and 2 month after study arrival. Method of measurement: beck depression inventory 2. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRayehe Tavajohi
Tehran University of Medical Sciences
Outcome results
None listed