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

• Status: Recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Generalized myasthenia gravis (MGFA IIa-IVb) at screening, verified by ≥ 1 of the following: 1) AchR-antibodies in medical history, 2) Abnormal decrement on repetitive nerve stimulation in medical history

• Disease duration of ≥ 1 year

• Stable dose of antimyasthenic medications at screening

• Residual symptoms with a MG-QOL15 score of ≥ 10

• Age ≥ 18 years

• Ability to understand the requirements of the trial and provide written, informed consent

Exclusion Criteria:

• Evidence of malignancy ≤ 3 years prior to screening, unless deemed completely cured

• Thymectomy ≤ 6 months prior to screening

• Impending MG crisis or respiratory insufficiency

• Worsening of MG symptoms due to other diseases or medications (e.g. infection, beta-blockers, aminoglycosides, etc.)

• Other factor(s) or medical condition(s) that may explain residual symptoms

• Pregnancy or breast-feeding

• Treatment with beta-agonists

• Uncontrolled diabetes

• Ischemic Heart Disease, Cardiac Arrhythmia or Heart Failure (including hypertrophic cardiomyopathy)

• Uncontrolled Hypertension (≥ 160/110)

• Known hypersensitivity to any of the study drug components

• Treatment with tricyclic antidepressants, monoamineoxidase inhibitors, digoxine, or methylxanthines.