Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis — BETA-MG  

Myasthenia Gravis Clinical Trial

Official title: Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis

Status Recruiting

Clinical Trial Summary

This study examines the effect of adjuvant therapy with the oral beta-agonist Salbutamol in patients with generalized myasthenia gravis on stable standard of care having residual symptoms.

Clinical Trial Description

Myasthenia Gravis (MG) causes various degrees of increased muscular fatigue and ocular, bulbar, respiratory and extremity symptoms.

Residual symptoms often remain despite treatment with acetylcholinesterase inhibitors and immunosuppressive agents. Escalation of immunosuppressive treatment may provide additional benefit but is associated with potentially severe side effects, and high economic costs.

Treatment with beta-agonists has been investigated in animal models of MG, and in small, randomized pilot studies of generalized MG. Adjuvant therapy with oral beta-agonists in MG may be safe and cheap and may improve symptoms.

The trial will examine the tolerability and efficacy of adjuvant therapy with the oral beta-agonist Salbutamol in patients with generalized myasthenia gravis on stable standard of care having residual symptoms.

Present study is an investigator-initiated, randomized, placebo-controlled, rater and subject-blinded crossover study.

Study consists of Screening Period (4 weeks), Treatment Period 1 (8 weeks), Washout Period (4 weeks), Treatment Period 2 (8 weeks). ;

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

• NCT number: NCT03914638
• Study type: Interventional
• Source: University of Aarhus
• Contact: Jan LS Thomsen, MD
• Phone: 78450000
• Email: jathms@rm.dk
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2019
• Completion date: October 31, 2021