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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT05625568
Eligibility Criteria:
Inclusion Criteria:
* Females age 18-45 (inclusive)
* Diagnosis of classic/typical Rett syndrome with a documented mutation of the MeCP2 gene
* Severity rating of between 10 and 36 (Rett Syndrome Natural History/Clinical Severity Scale)
* Concomitant medications (including approved medications for treatment of Rett syndrome) must be stable for \>4 weeks prior to enrollment
* Able to receive liquid study drug orally or via gastrostomy tube (G-tube)
Exclusion Criteria:
* Actively undergoing neurological regression;
* Abnormal QT interval, prolongation or significant cardiovascular history
* Excluded concomitant medications
* Current clinically significant (as determined by the investigator). cardiovascular, endocrine, hepatic, renal, or respiratory disease
* Gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication
* History of, or current cerebrovascular disease or brain trauma
* History of, or current, malignancy
* Clinically significant abnormalities in safety laboratory tests, vital signs, or ECG, as measured at screening or baseline
* Any condition which in the investigator's opinion would affect the ability of the subject to participate in the study
* Allergy to VYNT-0126 or any ingredients of the liquid formulation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05625568
Study Brief:
Protocol Section:
NCT05625568