Clinical trial · Interventional
Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis
NCT03914638CI-TRIAL-00044475BETA-MGunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study examines the effect of adjuvant therapy with the oral beta-agonist Salbutamol in patients with generalized myasthenia gravis on stable standard of care having residual symptoms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo oral capsule | Drug | — | UNRESOLVED |
| Salbutamol 4Mg Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active
- description
- Active intervention arm. Treatment for 8 weeks per treatment period.
- interventionNames
- Drug: Salbutamol 4Mg Tablet
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo arm. Treatment for 8 weeks per treatment period.
- interventionNames
- Drug: Placebo oral capsule
Primary outcomes (2)
- measure
- Myasthenia Gravis Quality of Life 15-items (MG-QOL15)
- timeFrame
- 8 weeks (Treatment Period 1), 8 weeks (Treatment Period 2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Generalized myasthenia gravis (MGFA IIa-IVb) at screening, verified by ≥ 1 of the following: 1) AchR-antibodies in medical history, 2) Abnormal decrement on repetitive nerve stimulation in medical history * Disease duration of ≥ 1 year * Stable dose of antimyasthenic medications at screening * Residual symptoms with a MG-QOL15 score of ≥ 10 * Age ≥ 18 years * Ability to understand the requirements of the trial and provide written, informed consent Exclusion Criteria: * Evidence of malignancy ≤ 3 years prior to screening, unless deemed completely cured * Thymectomy ≤ 6 months prior to screening * Impending MG crisis or respiratory insufficiency * Worsening of MG symptoms due to other diseases or medications (e.g. infection, beta-blockers, aminoglycosides, etc.) * Other factor(s) or medical condition(s) that may explain residual symptoms * Pregnancy or breast-feeding * Treatment with beta-agonists * Uncontrolled diabetes * Ischemic Heart Disease, Cardiac Arrhythmia or Heart Failure (including hypertrophic cardiomyopathy) * Uncontrolled Hypertension (≥ 160/110) * Known hypersensitivity to any of the study drug components * Treatment with tricyclic antidepressants, monoamineoxidase inhibitors, digoxine, or methylxanthines.
References
Publications (0)
Data not yet available
No reference posted for this study.