Assessment of the effect of lisdexamfetamine on fatigue in patients with multiple sclerosis
- Conditions
- Multiple sclerosis related fatigue.Multiple sclerosis
- Registration Number
- IRCT20230125057221N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue score in MFIS questionnaire. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: MFIS questionnaire.
- Secondary Outcome Measures
Name Time Method 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.