Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis
NCT ID: NCT03510546
Last Updated: 2018-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
44 participants
INTERVENTIONAL
2018-04-09
2021-08-31
Brief Summary
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Detailed Description
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Pyridostigmine treatment is initiated in the vast majority of MG patients. No studies have quantified the effect in a randomized trial, and no studies have examined the potential difference in effect in newly diagnosed patients as compared to patients on stable, antimyasthenic medications.
The study will investigate the effect in two groups
1. Newly diagnosed, treatment-naive patients.
2. MG patients on stable antimyasthenic medication.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Active
De-novo: Each capsule contains 60 mg. pyridostigmine. 1 capsule is administered twice within 4 hours.
Chronic: Each capsule contains 60 mg. pyridostigmine. Number of administered capsules per dosage depend on the patient's usual dosage. Study drug is administered twice within 4 hours.
Patients are examined/rated before 1st dose, 1 hour after 1st dose, 1 hour after 2nd dose (Visit 1). After cross-over (Visit 2), patients will be rated open-label at 1 month (Visit 3) and 3 months (Visit 4).
Pyridostigmine
Study dose as per protocol.
Placebo
Same as "Active", however capsules contain placebo.
Placebo oral capsule
Study dose as per protocol.
Interventions
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Pyridostigmine
Study dose as per protocol.
Placebo oral capsule
Study dose as per protocol.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known cardio-pulmonary disease
* Known neuropathy
* Known myopathy
* Known malignant disease
* Pregnancy or breastfeeding
* Mechanic ileus, urinary tract obstruction, peritonitis
De-novo MG Eligibility Criteria
* MG diagnosis \< 2 months, no prior antimyasthenic medications
Chronic MG Eligibility Criteria
* MG diagnosis \> 1 year, and stable pyridostigmine dosis
18 Years
90 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Jan Lykke Scheel Thomsen
MD, PhD Fellow
Principal Investigators
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Jan LS Thomsen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Department of Neurology Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Barnett C, Katzberg H, Nabavi M, Bril V. The quantitative myasthenia gravis score: comparison with clinical, electrophysiological, and laboratory markers. J Clin Neuromuscul Dis. 2012 Jun;13(4):201-5. doi: 10.1097/CND.0b013e31824619d5.
Burns TM, Conaway M, Sanders DB; MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology. 2010 May 4;74(18):1434-40. doi: 10.1212/WNL.0b013e3181dc1b1e.
Other Identifiers
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Mestinon2018
Identifier Type: -
Identifier Source: org_study_id
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