Effect of pyridostigmine (Mestinon®) on muscle strength in Myasthenia Gravis.
Phase 1
- Conditions
- Myasthenia GravisMedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2017-002599-15-DK
- Lead Sponsor
- Aarhus University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 32
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
Cardio-pulmonary disease, neuropathy, myopathy, malignant disease, pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).