multiple sclerosis
Conditions
Interventions
Intervention: beta-2 adrenergic agonist (salbutamol sulfate) 2 mg 1 caplet oral BID for 90 days in 60 participants
Placebo: 2 mg 1 caplet oral BID for 90 days in 60 participants
Drug
Sponsors
Hospital de Clínicas da Universidade Federal do Paraná
Hospital de Clínicas da Universidade Federal do Paraná
Eligibility
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: Diagnosis of Multiple Sclerosis (according to McDonald's 2010 criteria); age between 18 and 70 years old; Expanded Disability Status Scale score (EDSS) up to 5.5; fatigue confirmed by Neurological Fatigue Index for Multiple Sclerosis validated for Brazil (NFI-MS/BR) and Fatigue Severity Scale (FSS)
Exclusion criteria
Exclusion criteria: Multiple sclerosis relapse within 30 days prior to the study; poorly controlled hypothyroidism despite of treatment; any tachyarrhythmia identified on the electrocardiogram (ECG); decompensation of chronic systemic or psychiatric diseases (such as arterial hypertension, renal and hepatic impairment, and diabetes); pregnancy or lactation; not signing the consent term.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: improvement of fatigue, verified by change in Fatigue Severity Scale (FSS) score between salbutamol and placebo groups with p value <0.05 indicating statistical significance after 30, 60 and 90 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: improvement in physical, cognitive and somnolence related to fatigue, verified by changing at Neurological Fatigue Index for Multiple Sclerosis/validated to Brazil (NFI-MS/BR) between salbutamol and placebo groups with p value <0.05 indicating statistical significance after 30, 60 and 90 days. ;Expected outcome 3: changing on fatigue severity classification assessed by Fatigue Severity Scale (FSS) between salbutamol and placebo groups with p value <0.05 indicating statistical significance after 30, 60 and 90 days. ;Expected outcome 4: improvement on disability evaluated by Expanded Disability Status Scale score (EDSS) between salbutamol and placebo groups with p value <0.05 indicating statistical significance after 90 days.;Expected outcome 5: safety by means of the registration about duration, severity and action taken face any side effect. | — |
Countries
Brazil
Contacts
Public ContactRosana;Rosana Scola;Scola
Hospital de Clínicas da Universidade Federal do Paraná;Hospital de Clínicas da Universidade Federal do Paraná
Outcome results
None listed