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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07377032
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of a GRIN-related neurodevelopmental disorder (GRIN-NDD)
* Presence of a pathogenic or likely pathogenic loss-of-function (LoF) variant in GRIN1, GRIN2A, GRIN2B, or GRIN2D
* Parent(s), caregiver(s), or legally authorised representative(s) have been informed of the nature of the study and have provided written informed consent.
* Participants who are able to do so have provided written informed consent or assent, according to local regulations and cognitive capacity.
* Parent(s)/caregiver(s) are willing and able to comply with study procedures and visits, in the opinion of the investigator.
* Participants who have previously received L-serine supplementation are willing to discontinue L-serine for at least one week prior to the baseline observation period.
Exclusion Criteria:
* Age younger than 2 years at screening.
* Known hypersensitivity or intolerance to L-serine, placebo, or any excipients used in the study formulations.
* Presence of a clinically significant unstable medical condition (other than epilepsy) that, in the investigator's judgement, may place the participant at increased risk or interfere with study participation.
* Any other significant disease or disorder that may compromise participant safety, affect study outcomes, or impair the participant's ability to complete the study procedures.
* Inadequate supervision by parent(s) or caregiver(s), as judged by the investigator.
* Participation in another clinical trial involving an investigational medicinal product within the previous 6 months.
* Female participants who are pregnant or breastfeeding.
* Presence of a GRIN1, GRIN2A, GRIN2B, or GRIN2D variant for which a clear loss-of-function effect cannot be demonstrated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
30 Years
Study:
NCT07377032
Study Brief:
Protocol Section:
NCT07377032