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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT06128356
Eligibility Criteria:
Inclusion Criteria:
* Genetically confirmed diagnosis of Familial Dysautonomia.
* Evidence of autonomic crisis, previous treatment with IV dexmedetomidine without significant side effects, and registered medical data within the year preceding the study in our database.
* One or more autonomic crises during the last year.
* Age above 18 years.
* The patient has a responsible caretaker to communicate with the medical providers.
* Provision of signed and dated informed consent form from the patient and responsible caregiver.
* Able to state willingness to comply with all study procedures and availability for the duration of the study
* For males and females of reproductive potential: use condoms for contraception if sexually active.
Exclusion Criteria:
* At the consideration of the principal investigator, the caregiver cannot fully understand the protocol or communicate during the crisis with the Center.
* The patient during the crisis, before taking the medication, has any of the following:
* a. Oxygen saturation less than 92% on room air or baseline need for oxygen, change from baseline oxygen dependency.
* b. Respiratory rate \>20 breaths per minute.
* c. Supine blood pressure ≤ 90/60mmHg
* d. Febrile illness with temperature \>100.3 F.
* e. Serological signs of infection (WBC count \>10 g/dL, or CRP \>10 mg/L or ESR\>20, or above their steady historical baseline levels) in recent (less than one month) studies.
* The patient is a female and has a positive pregnancy test.
* MoCA score \<25 points.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06128356
Study Brief:
Protocol Section:
NCT06128356