Pharmacokinetic - pharmacodynamic study of amifampridine modified release in LEMS patients
- Conditions
- Lambert-Eaton Myasthenic SyndromeLEMS10029317
- Registration Number
- NL-OMON56948
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
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
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic parameters: Tmax, Cmax, AUC, VD, Ctrough,SS. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacodynamic endpoints: 3TUG scores, subject global impression (SGI) and<br /><br>CMAP amplitude. The occurrence of side effects will also be assessed.</p><br>