NCT03914638

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Salbutamol 4Mg Tablet	Salbutamol 4 mg, three times daily
DRUG	Placebo oral capsule	Placebo, three times daily

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2019-04-16
• Last updated: 2020-04-06

Locations

2 sites across 1 country: Denmark