Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01373333
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of LEMS with or without any of the following: evidence of underlying malignancy, presence of P/Q or N-type calcium channel antibodies, electrodiagnostic evidence of a presynaptic defect of neuromuscular junction transmission.None of these laboratory findings are required for inclusion in this study.
2. P/Q and N type calcium channel antibodies are measured in the blood as a routine laboratory test during the course of initial diagnosis, but 10-20% of patients with LEMS do not have elevated levels of these antibodies.
Exclusion Criteria:
1. Hypersensitivity to any component of this medication.
2. History of past or current seizures.
3. History of asthma.
4. Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the QTc interval.
5. Family history of prolonged QTc syndrome, history of unexplained syncope, seizures or cardiac arrest.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01373333
Study Brief:
Protocol Section:
NCT01373333