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

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03510546
• Other study ID #: Mestinon2018
• Status: Recruiting
• Phase: Phase 4
• First received: April 6, 2018
• Last updated: April 17, 2018
• Start date: April 9, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2018
• Source: University of Aarhus
• Contact: Jan LS Thomsen, MD
• Phone: +45 7846 6647
• Email: jathms[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

The study aims to evaluate and quantify the effect of pyridostigmine on symptoms and muscle strength in newly-diagnosed patients and patients on stable medication.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Drug:
• Pyridostigmine
Study dose as per protocol.
• Placebo oral capsule
Study dose as per protocol.

Locations

Country	Name	City	State
Denmark	Department of Neurology Aarhus University Hospital	Aarhus	Midtjylland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QMG	Quantitative Myasthenia Gravis (QMG) scale rate disease severity of myasthenia gravis on 13 items with a total score ranging from 0-39 (higher values representing more severe disease). Total score (0-39), ocular subitems (0-6), bulbar subitems (0-9), extremity/axial subitems (0-21) and respiratory subitem (0-3) will be reported.	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	Change in muscle strength as assessed by dynamometry (Biodex System 3).	Peak muscle torque expressed in newton meters based on 3 repeated maximal isometric contractions. Performed on shoulder abduction and knee extension.	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	Change in muscle fatigue as assessed by dynamometry (Biodex System 3).	Decrement in peak muscle torque expressed in newton meters per contraction during up to 50 repetitive maximal isokinetic contractions. Performed on shoulder abduction and knee extension.	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	Change in MG Composite Score	The Myasthenia Gravis Composite (MG composite) scale rate disease severity of myasthenia gravis on 10 items with a score ranging from 0-50 (higher values representing more severe disease).	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).