Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis

Last updated: April 17, 2018
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

4

Condition

Sarcopenia

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Treatment

N/A

Clinical Study ID

NCT03510546
Mestinon2018
  • Ages 18-90
  • All Genders

Study Summary

A randomized, placebo-controlled, double-blinded cross-over study evaluating and quantifying the effect of pyridostigmine on muscle strength and symptoms in Myasthenia Gravis (MG)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • MG verified by a) anti-body, or b) single-fiber EMG and/or decrement on ENG.

Exclusion

Exclusion Criteria:

  • Anti-MuSK

  • Known cardio-pulmonary disease

  • Known neuropathy

  • Known myopathy

  • Known malignant disease

  • Pregnancy or breastfeeding

  • Mechanic ileus, urinary tract obstruction, peritonitis De-novo MG Eligibility Criteria

  • MG diagnosis < 2 months, no prior antimyasthenic medications Chronic MG Eligibility Criteria

  • MG diagnosis > 1 year, and stable pyridostigmine dosis

Study Design

Total Participants: 44
Study Start date:
April 09, 2018
Estimated Completion Date:
August 31, 2021

Study Description

The study aims to evaluate and quantify the effect of pyridostigmine on symptoms and muscle strength in newly-diagnosed patients and patients on stable medication.

Pyridostigmine treatment is initiated in the vast majority of MG patients. No studies have quantified the effect in a randomized trial, and no studies have examined the potential difference in effect in newly diagnosed patients as compared to patients on stable, antimyasthenic medications.

The study will investigate the effect in two groups

  1. Newly diagnosed, treatment-naive patients.

  2. MG patients on stable antimyasthenic medication.

Connect with a study center

  • Department of Neurology Aarhus University Hospital

    Aarhus, Midtjylland 8000
    Denmark

    Active - Recruiting

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