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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT03644693
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* 4-11 years of age
* Diagnosed with Angelman syndrome with prior lab report indicating genetic diagnosis
* Currently on a LGIT, KD, or standard diet consistently for at least three months
* Motivated to maintain the LGIT or KD for at least the duration of the trial period, as applicable
* Written informed consent from patient and/or parent/caregiver
* Willing to drink provided formulations, or to eat them mixed with food
* Daytime toilet trained, or parents willing to use cotton balls in diapers to sample urine
* Willing to test urine daily
* Willing to comply with protocol examinations, including EEG, ERP, and venipuncture
* Ambulatory, willing to perform gait tracking
Exclusion Criteria:
* Being pregnant or planning pregnancy
* Requiring parenteral nutrition
* Major hepatic or renal dysfunction
* History of a diagnosis of diabetes
* Participation in other clinical intervention studies within 1 month prior to entry of this study
* Allergy to any of the study product ingredients
* Investigator concern around willingness/ability of patient or parent/caregiver to comply with protocol requirements
* Any contraindications for the use of the ketogenic or low carbohydrate diets
* Significantly underweight (Body Mass Index \<18.5)
* Unwilling to drink provided formulations, or to consume formulation mixed with food
* Not ambulatory, or unwilling to perform gait tracking
* Not daytime toilet trained, or parents unwilling to use cotton balls in diapers to sample urine
* Unwilling to test urine daily
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
11 Years
Study:
NCT03644693
Study Brief:
Protocol Section:
NCT03644693