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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT05581732
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of cerebral palsy, spastic and hyperkinetic forms;
* Class of cerebral palsy GMFCS 2-3;
* Z-score BMI ≤ -1;
* The patient's ability to safely swallow liquid food;
* Availability of informed consent signed by the patient's legal representative for inclusion in the study and processing of personal data.
Exclusion Criteria:
* Individual intolerance to the investigational product components;
* Galactosemia;
* Allergy to cow's milk proteins and other food intolerances;
* Participation in another clinical study currently or in the past 30 days;
* Any other medical or non-medical reason that, in the physician's opinion, may prevent the patient from participating in the study.
* Deterioration of the patient's condition requiring his transfer to enteral or parenteral nutrition;
* Transfer of a patient to another hospital;
* Complications that could be caused by the investigational product (diarrhea, nausea, vomiting, allergies, etc.);
* Withdrawal for a safety reason
* Refusal of the patient (his legal representative) from further participation in the study and withdrawal of informed consent to participate in the study and the processing of personal data. At the same time, the exclusion of a patient from the study should not affect the nature of his therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT05581732
Study Brief:
Protocol Section:
NCT05581732