Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03510546
• Date of registration: 06/04/2018
• Prospective Registration: Yes
• Primary sponsor: University of Aarhus
• Public title: Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis
• Scientific title: Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis
• Date of first enrolment: April 9, 2018
• Target sample size: 44
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03510546
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Jan LS Thomsen, MD

• Name: Jan LS Thomsen, MD
• Affiliation: Department of Clinical Medicine, Aarhus University

• Name: Jan LS Thomsen, MD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Drug: Placebo oral capsule

Drug: Pyridostigmine

Primary Outcome(s)

Change in QMG [Time Frame: At baseline, 1 hour after 1st dose (administered immediately after baseline assessment), 1 hour after 2nd dose (administered 2 hours after 1st dose). Assessed on Day 1 and Day 2 (cross-over), at Follow-up 1 (1 month) and Follow-up 2 (3 months).]

Secondary Outcome(s)

Change in MG Composite Score [Time Frame: At baseline, 1 hour after 1st dose (administered immediately after baseline assessment), 1 hour after 2nd dose (administered 2 hours after 1st dose). Assessed on Day 1 and Day 2 (cross-over), at Follow-up 1 (1 month) and Follow-up 2 (3 months).]

Change in muscle fatigue as assessed by dynamometry (Biodex System 3). [Time Frame: At baseline, 1 hour after 1st dose (administered immediately after baseline assessment), 1 hour after 2nd dose (administered 2 hours after 1st dose). Assessed on Day 1 and Day 2 (cross-over), at Follow-up 1 (1 month) and Follow-up 2 (3 months).]

Change in muscle strength as assessed by dynamometry (Biodex System 3). [Time Frame: At baseline, 1 hour after 1st dose (administered immediately after baseline assessment), 1 hour after 2nd dose (administered 2 hours after 1st dose). Assessed on Day 1 and Day 2 (cross-over), at Follow-up 1 (1 month) and Follow-up 2 (3 months).]

Secondary ID(s)

Mestinon2018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aarhus University Hospital