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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03914638 |
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Date of registration:
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11/04/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis
BETA-MG |
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Scientific title:
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Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis |
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Date of first enrolment:
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April 1, 2019 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03914638 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jan LS Thomsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Clinical Medicine, Aarhus University |
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Name:
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Jan LS Thomsen, MD |
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Address:
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Telephone:
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78450000 |
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Email:
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jathms@rm.dk |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myasthenia Gravis
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Intervention(s)
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Drug: Salbutamol 4Mg Tablet
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Drug: Placebo oral capsule
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Primary Outcome(s)
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Treatment Tolerability
[Time Frame: 8 weeks (Treatment Period 1), 8 weeks (Treatment Period 2)]
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Myasthenia Gravis Quality of Life 15-items (MG-QOL15)
[Time Frame: 8 weeks (Treatment Period 1), 8 weeks (Treatment Period 2)]
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Secondary Outcome(s)
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Quantitative Myasthenia Gravis (QMG)
[Time Frame: 8 weeks (Treatment Period 1), 8 weeks (Treatment Period 2)]
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Myasthenia Gravis Composite (MG-Composite)
[Time Frame: 8 weeks (Treatment Period 1), 8 weeks (Treatment Period 2)]
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Myasthenia Gravis Activity of Daily Living (MG-ADL)
[Time Frame: 8 weeks (Treatment Period 1), 8 weeks (Treatment Period 2)]
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Neuro QOL
[Time Frame: 8 weeks (Treatment Period 1), 8 weeks (Treatment Period 2)]
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Secondary ID(s)
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BETA-MG-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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