Fatigue treatment in multiple sclerosis patients

Phase 2

Recruiting

• Conditions: fatigue; multiple sclerosis; malaise; C10.114.375.500

• Registration Number: RBR-5y5sm9
• Lead Sponsor: Hospital de Clínicas da Universidade Federal do Paraná

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>;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.