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

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University of Aarhus

Status and phase

Unknown
Phase 4

Conditions

Myasthenia Gravis

Treatments

Drug: Pyridostigmine
Drug: Placebo oral capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT03510546
Mestinon2018

Details and patient eligibility

About

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)

Full 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 Newly diagnosed, treatment-naive patients. MG patients on stable antimyasthenic medication.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

44 participants in 2 patient groups, including a placebo group

Active
Experimental group
Description:
De-novo: Each capsule contains 60 mg. pyridostigmine. 1 capsule is administered twice within 4 hours. Chronic: Each capsule contains 60 mg. pyridostigmine. Number of administered capsules per dosage depend on the patient's usual dosage. Study drug is administered twice within 4 hours. Patients are examined/rated before 1st dose, 1 hour after 1st dose, 1 hour after 2nd dose (Visit 1). After cross-over (Visit 2), patients will be rated open-label at 1 month (Visit 3) and 3 months (Visit 4).
Treatment:
Drug: Pyridostigmine
Placebo
Placebo Comparator group
Description:
Same as "Active", however capsules contain placebo.
Treatment:
Drug: Placebo oral capsule

Trial contacts and locations

1

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Central trial contact

Jan LS Thomsen, MD; Henning Andersen, MD PhD DMSc

Data sourced from clinicaltrials.gov

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