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New treatment option for GRIN-related Disorders
Official title TAP-GRIN: Interventional Study on Patients With GRIN-related Neurodevelopmental Disorders
ClinicalTrials.gov ID: NCT07377032
What this study is testing
- What it's testing
- The goal of this clinical study is to find out whether L-serine dietary supplementation helps improve overall clinical functioning in children and young adults (2-30 years) with GRIN-related neurodevelopmental disorders (GRIN-NDD) caused by loss-of-function (LoF) variants in GRIN1, GRIN2A, GRIN2B, or GRIN2D. It will also assess the safety and tolerability of L-serine.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 30
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Any other significant disease or disorder that may compromise participant safety, affect study outcomes, or impair the participant's ability to...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Florence, Italy
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Florence, Italy; Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.