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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT03059160
Eligibility Criteria:
Inclusion Criteria:
* Female patients aged 5 to18 years (inclusive).
* A classical diagnosis of RTT, defined according to the internationally agreed 2010 Rett Search criteria, and with MECP2 pathogenic mutation.
* Patients with one or both of the following:
* At least 2 seizures per month as per history during the four-week baseline period according to parent diary or per 3 hours video EEG recording
* Walking abilities, independent or with support
* Patients with breathing abnormalities as recorded by baseline NOX recording.
Exclusion Criteria:
* Patients with significant metabolic, liver, cardiac, or respiratory morbidity not related to RTT
* Patients with significant liver, cardiac or respiratory morbidity related to RTT
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT03059160
Study Brief:
Protocol Section:
NCT03059160