Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis
Phase 1
- Conditions
- MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Myasthenia Gravis
- Registration Number
- EUCTR2019-000895-40-DK
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Generalized myasthenia gravis, stable dose of antimyasthenic medications, residual symptoms (MG-QOL15 > 10), age > 18 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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
Malignant disease, worsening of symptoms due to concomitant diseases/medications, pregnancy/breast feeding, ischemic heart disease/cardiac arrhytmia/uncontrolled hypertension/uncontrolled diabetes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy and tolerability of oral Salbutamol as adjuvant therapy in patients with generalized myasthenia gravis on stable medications with residual symptoms.;Secondary Objective: Not applicable;Primary end point(s): Change in MG-QOL15 score;Timepoint(s) of evaluation of this end point: Visit 4 vs. visit 2 (treatment period 1). Visit 7 vs. visit 5 (treatment period 2)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change in MG-ADL, QMG, MG-Composite, Neuro-QOL, ;Timepoint(s) of evaluation of this end point: Visit 4 vs. visit 2 (treatment period 1). Visit 7 vs. visit 5 (treatment period 2)