Improving symptomatic treatment with pyridostigmine and amifampridine: a randomized double-blinded, placebo controlled crossover trial in patients with myasthenia gravis (IMPACT-MG)

Phase 3

Recruiting

• Conditions: myasthenia; Myasthenia Gravis; 10029317

• Registration Number: NL-OMON54093
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Age >18 years
2. AChR positive myasthenia gravis (ocular or generalized)
3. Current use of pyridostigmine
4. MGFA Clinical Classification I-IV
5. Receiving a stable dose of MG treatment (other than pyridostigmine). If
applicable:
a. A stable steroid regimen for 1 month
b. Nonsteroidal immunosuppressants:
i. Azathioprine, mycophenolate mofetil, cyclosporine or other nonsteroid
immunosuppressive agents start >3 months ago and a stable regimen for 1 month.
ii. Rituximab start >6 months ago, complement inhibitors and Fc receptor
inhibitors start > 6 months ago and a stable regimen for 3 months.

Exclusion Criteria

1. Use of intravenous immunoglobulin or plasma exchange <4 weeks
2. Thymectomy >6 months, or thymectomy (expected) to take place during the trial
3. Use of other AChE inhibitors than pyridostigmine
4. Pregnancy, lactation or intention to become pregnant during the study
5. Treatment with 3,4-DAP is contraindicated. Contraindications include a
history of epilepsy, uncontrolled asthma, inherited QT syndrome / a prolonged
QT interval (as indicated by ECG), any drug known to cause QTc-prolongation,
concomitant use of sultopride, a known hypersensitivity reaction to the active
substance or to any of the excipients.
6. The patient is unable to fill out the study questionnaires or be interviewed
in Dutch, or is unable to undergo the tests needed for the study, or is unable
to give informed consent for participation in the study.
7. The investigator can exclude patients for this trial which are deemed not
suitable for any reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study is a clinically relevant change in MGII<br /><br>compared to placebo. A change of >=8 is considered clinically relevant.</p><br>