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

INTERVENTION: 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: equal Concentration number: 60‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: Myasthenia Gravis ; MedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: 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. Primary end point(s): Change on clinical rating scales Secondary Objective: Not applicable. Timepoint(s) of evaluation of this end point: Before and after administration, and during follow‐up (3 months). SECONDARY OUTCOME: 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). 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