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:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT01825395
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older,
* Diagnosed with LEMS,
* If female, have a negative pregnancy test, and
* If premenopausal, be willing to practice an effective form of birth control during the study,
* Tested and found by ECG not to have a prolonged QT syndrome,
* Agree to have a second ECG at the time of peak drug effect,
* Has understood and signed the Informed Consent.
Exclusion Criteria:
* Is known to have a sensitivity to 3, 4-DAP,
* Has a history of:
1. past or current seizures,
2. cardiac arrhythmia,
3. hepatic, renal or hematologic disease, or
4. severe asthma,
* Is believed by the investigator to be unable to comply with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01825395
Study Brief:
Protocol Section:
NCT01825395