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NCT07413211 · ClinicalTrials.gov registry record
Genetic Developmental and Epileptic Encephalopathy Natural History Study for Clinical Trial Readiness
A clinical trial of MEF2C and DEE, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- 22,068
- Enrollment target
- 1
- Study location
NCT07413211: Recruiting study of MEF2C and DEE, sponsored by Weill Medical College of Cornell University.
NCT07413211 is a study of MEF2C and DEE that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 22,068 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07413211, a study of MEF2C and DEE, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- 22,068 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase 0 non-interventional longitudinal study of children and adults with Developmental and Epileptic Encephalopathy (DEE) due to a genetic cause. There are six arms of the study. Arms 1, 2, and 3 are devoted to one example DEE, MEF2C Haploinsufficiency Syndrome (MCHS). Arms 4, 5, and 6 are open to all DEE. Arm 1 (in-person) will enroll children 0 to 15, who will make in-person visits to Weill Cornell Medicine four times over two years. Arm 2 (virtual) will enroll people of all ages and older who will make virtual visits over Weill Cornell Zoom to Weill Cornell Medicine over two years (2 if 16 and older; 4 if 0 to 15). Arm 3 (registry) will enroll people of all ages in an online-only survey. Arms 4 - 6 mirror this structure but they are open to all children with DEE. Arm 4 (in-person) will enroll children of any age, who will make in-person visits every 6 months for 10 years. Arm 5 (virtual) will enroll children of any age for virtual visits, twice a year of 0 to 15, once a year if 16 or older. Arm 6 (registry) will enroll people of all ages in an online only survey.
Primary Outcome
Bayley-4 is a standardized assessment tool designed to evaluate children from age 1 month to 42 months. Bayley-4 assesses multiple areas of development, including cognitive, language, motor, social/emotional, and adaptive behavior. It is considered a gold standard by clinicians and researchers. In clinical studies of developmental disorders, Bayley-4 can be used in children older than 42 months. We track scores using the "age equivalent" metric, which runs from 0 month to 42 months in each subdo
Interventions
- OTHER Observation
Study Locations (1)
New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22,068 participants |
| Start Date | 2025-02-26 |
| Est. Completion | 2037-04-30 |
What NCT07413211 shows while recruiting
NCT07413211 is an observational study that tracks outcomes without assigning an intervention. Its 22,068 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with MEF2C appearing as the primary indexed condition, and to 1 intervention - of which Observation is the first listed.
NCT07413211 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07413211 about?
NCT07413211 is a clinical study titled "Genetic Developmental and Epileptic Encephalopathy Natural History Study for Clinical Trial Readiness". Phase 0 non-interventional longitudinal study of children and adults with Developmental and Epileptic Encephalopathy (DEE) due to a genetic cause. There are six arms of the study. Arms 1, 2, and 3 are devoted to one example DEE, MEF2C Haploinsufficiency Syndrome (MCHS). Arms 4, 5, and 6 are open to ...
What is the current status of trial NCT07413211?
This trial is currently recruiting. The enrollment target is 22,068 participants. The study started on 2025-02-26. Estimated completion is 2037-04-30.
What conditions does trial NCT07413211 study?
This clinical trial studies the following conditions: MEF2C, DEE.
What interventions are being tested in trial NCT07413211?
The interventions under investigation include: Observation (OTHER).
Who is sponsoring clinical trial NCT07413211?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07413211 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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