Effect of pyridostigmine (Mestinon®) on muscle strength in Myasthenia Gravis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002599-15-DK

Enrollment

Registered

2017-07-07

Start date

2017-11-07

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis MedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859

Interventions

Trade Name: Mestinon Pharmaceutical Form: Capsule INN or Proposed INN: pyridostigmine CAS Number: 155-97-5 Other descriptive name: PYRIDOSTIGMINE Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Acetylcholine-receptor antibody positive Myasthenia Gravis, Age 18-90 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Cardio-pulmonary disease, neuropathy, myopathy, malignant disease, pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate and quantify the effect of pyridostigmine (Mestinon) on symptoms and motor performance in patients with Myasthenia Gravis in a randomized, double-blinded and placebo-controlled study.;Secondary Objective: Not applicable.;Primary end point(s): Change on clinical rating scales;Timepoint(s) of evaluation of this end point: Before and after administration, and during follow-up (3 months).	—

Measure

Time frame

Main Objective: To evaluate and quantify the effect of pyridostigmine (Mestinon) on symptoms and motor performance in patients with Myasthenia Gravis in a randomized, double-blinded and placebo-controlled study.;Secondary Objective: Not applicable.;Primary end point(s): Change on clinical rating scales;Timepoint(s) of evaluation of this end point: Before and after administration, and during follow-up (3 months).

—

Secondary

Measure	Time frame
Secondary end point(s): Change in force measured with dynamometry.;Timepoint(s) of evaluation of this end point: Before and after administration, and during follow-up (3 months).	—

Countries

Denmark

Contacts

Public ContactJan L. S. Thomsen

Aarhus University

jathms@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026