Pharmacokinetic - pharmacodynamic study of amifampridine modified release in LEMS patients

Pharmacokinetic - pharmacodynamic study of amifampridine modified release in LEMS patients - PKPD of amifampridine MR in LEMS patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56948

Enrollment

Registered

2024-02-02

Start date

2026-03-27

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lambert-Eaton Myasthenic Syndrome LEMS LEMS

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Clinical diagnosis of LEMS 3. Presence of Voltage Gated Calcium Channel Antibodies (VGCC antibodies) 4. Current use of amifampridine modified release 5. Receiving a stable dose of amifampridine modified release

Exclusion criteria

Exclusion criteria: 1. The patient is unable to fill out the study questionnaires or be interviewed in Dutch or English, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study. 2. The investigator can exclude patients for this trial which are deemed not suitable for any reason.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters: Tmax, Cmax, AUC, VD, Ctrough,SS.	—

Secondary

Measure	Time frame
Pharmacodynamic endpoints: 3TUG scores, subject global impression (SGI) and CMAP amplitude and decrement. The occurrence of side effects will also be assessed.	—

Countries

Netherlands

Contacts

Public ContactW.R. Bakker

Leids Universitair Medisch Centrum

W.R.Bakker@lumc.nl0715266354

Outcome results