Clinical trial · Interventional
Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis
NCT03510546CI-TRIAL-00032701unknownPhase 4ClinicalTrials.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)
A randomized, placebo-controlled, double-blinded cross-over study evaluating and quantifying the effect of pyridostigmine on muscle strength and symptoms in Myasthenia Gravis (MG)
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 |
| Pyridostigmine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active
- description
- 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).
- interventionNames
- Drug: Pyridostigmine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Same as "Active", however capsules contain placebo.
- interventionNames
- Drug: Placebo oral capsule
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * MG verified by a) anti-body, or b) single-fiber EMG and/or decrement on ENG. Exclusion Criteria: * Anti-MuSK * 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
References
Publications (2)
- BACKGROUNDBarnett 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. PMID 22622164
- BACKGROUNDBurns 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. PMID 20439845