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

  • STATUS
    Recruiting
  • days left to enroll
    39
  • participants needed
    30
  • sponsor
    University of Aarhus
Updated on 24 January 2021
salbutamol
immunomodulator
generalized myasthenia gravis
repetitive nerve stimulation
salbutamol 4mg tablet

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.

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).

Details
Condition Myasthenia Gravis, Myasthenia Gravis generalised, Myasthenia Gravis (Chronic Weakness)
Treatment Placebo oral capsule, Salbutamol 4Mg Tablet
Clinical Study IdentifierNCT03914638
SponsorUniversity of Aarhus
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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