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NCT03538431 · ClinicalTrials.gov registry record · Phase 4
Improving Driving in Young People With Autism Spectrum Disorders
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT03538431: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT03538431 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03538431, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study will examine the effects of treatment with the anti-anxiety medicine buspirone on driving performance (eye tracking) in individuals with high-functioning autism spectrum disorder (HF-ASD). The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as two Driving Simulation visits that will take place at Massachusetts Institute of Technology (MIT). Subjects will be given buspirone and asked to take the medication for the two days preceding the Driving Simulation Visit.
Primary Outcome
Driving performance will be analyzed using eye tracking in individuals with Autism Spectrum Disorder while on the anti-anxiety medication buspirone and while not on buspirone. Eye movement behavior (measured by glance duration) during the driving simulation was manually coded on a frame-by-frame basis from recorded video by trained coders for all cases where usable video recordings were available for both the medicated and non-medicated driving simulation sessions per participant.
Interventions
- DRUG Buspirone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-10-31 |
| Est. Completion | 2019-12-16 |
| Phase | Phase 4 |
What the finished NCT03538431 record still lists
NCT03538431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Buspirone is the first listed.
NCT03538431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03538431 about?
NCT03538431 is a clinical study titled "Improving Driving in Young People With Autism Spectrum Disorders". This study will examine the effects of treatment with the anti-anxiety medicine buspirone on driving performance (eye tracking) in individuals with high-functioning autism spectrum disorder (HF-ASD). The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as two D...
What is the current status of trial NCT03538431?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2018-10-31. Estimated completion is 2019-12-16.
What interventions are being tested in trial NCT03538431?
The interventions under investigation include: Buspirone (DRUG).
Who is sponsoring clinical trial NCT03538431?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03538431's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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