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NCT02461459 · ClinicalTrials.gov registry record
Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)
A clinical trial of Intellectual Disability and Tuberous Sclerosis, sponsored by Boston Children's Hospital.
- Active
- Registry status
- 205
- Enrollment target
- 6
- Study locations
NCT02461459: Active study of Intellectual Disability and Tuberous Sclerosis, sponsored by Boston Children's Hospital.
NCT02461459 is a study of Intellectual Disability and Tuberous Sclerosis that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 205 participants, below the 346-participant average among 26 other Intellectual Disability trials with a reported enrollment target (41% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02461459, a study of Intellectual Disability and Tuberous Sclerosis, is active but no longer recruiting, sponsored by Boston Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 205 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to characterize the developmental phenotype of ASD and ID and to identify biomarkers using advanced MRI methodology and electrophysiological biomarkers of synaptic function and connectivity predictive of ASD and ID presence and severity in patients with TSC. In addition, this study will be establishing infrastructure for the collection and storage of human bio-specimens, including genetic material, from TSC patients and their family members with ASD.
Primary Outcome
Using standardized composite score for ADOS-2 performed yearly to determine ASD
Conditions Studied
Study Locations (6)
California
- University of California at Los Angeles - Los Angeles
- Stanford University - Palo Alto
Alabama
- University of Alabama at Birmingham - Birmingham
Massachusetts
- Boston Children's Hospital - Boston
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Texas
- University of Texas at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2015-05 |
| Est. Completion | 2026-12 |
What the registry record for NCT02461459 still lists
NCT02461459 is an observational study that tracks outcomes without assigning an intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, below the 346-participant average among 26 other Intellectual Disability trials with a reported enrollment target (41% lower).
The record links to 3 conditions, with Intellectual Disability appearing as the primary indexed condition, and to 0 interventions.
NCT02461459 lists 6 locations in 5 states (California, Alabama, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT02461459 about?
NCT02461459 is a clinical study titled "Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)". The purpose of this study is to characterize the developmental phenotype of ASD and ID and to identify biomarkers using advanced MRI methodology and electrophysiological biomarkers of synaptic function and connectivity predictive of ASD and ID presence and severity in patients with TSC. In addition,...
What is the current status of trial NCT02461459?
This trial is currently active not recruiting. The enrollment target is 205 participants. The study started on 2015-05. Estimated completion is 2026-12.
What conditions does trial NCT02461459 study?
This clinical trial studies the following conditions: Intellectual Disability, Tuberous Sclerosis, Autism Disorder.
Who is sponsoring clinical trial NCT02461459?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02461459 being conducted?
This trial has 6 study locations across Alabama, California, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Intellectual Disability
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02461459's enrollment target sits among peer trials
205 9th of 26 higher than 17 of 26 other Intellectual Disability trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intellectual Disability trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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