Autism Spectrum DisorderPhase 4NCT03538431

Improving Driving in Young People With Autism Spectrum Disorders

A Phase 4 study testing Buspirone in people with Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 24 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Buspirone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2018to 16 Dec 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder
Has a valid Driver's License

Who cannot join

Major sensorimotor handicaps (e.g. deafness, blindness)
Individuals who have never held a valid driver's license
Intellectual Deficiency (Verbal Comprehension Index < 80)
Inadequate command of the English language
Subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator
Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any reason
Pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Conditions: Autism Spectrum Disorder
Being tested: Buspirone
Keywords: Autism Spectrum Disorder, ASD, Anxiety
Medical subject headings: Autism Spectrum Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BuspironeDrug
Buspirone is an atypical anxiolytic medication.

Study groups in NCT03538431
Study group	Role	What they receive
Buspirone	Experimental	These subjects will receive buspirone prior to engaging in the driving simulation. Receives: Drug: Buspirone
Unmedicated	Experimental	These subjects will take no medication prior to engaging in the driving simulation Receives: Drug: Buspirone

What is being measured

The primary outcome is the main question the study is designed to answer.

Driving Performance - Measured by Mean Off-Road Glance Duration
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.
Measured: Up to 6 weeks
Heart Rate
Hyperarousal will be measured by heart rate during participants' time in the driving simulation.
Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 201816 Dec 2019

First posted29 May 2018
Study start31 Oct 2018
Primary completion16 Dec 2019
Study completion16 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03538431
Sponsor's protocol ID: 2018-P-000900
Status last verified: Mar 2021
First submitted: 14 May 2018
Last updated: 18 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autism Spectrum Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Driving in Young People With Autism Spectrum Disorders
ClinicalTrials.gov ID: NCT03538431
Acronym / sponsor ID: 2018-P-000900
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder, ASD, Anxiety
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Massachusetts Institute of Technology
Study start: 31 Oct 2018 (actual)
Primary completion: 16 Dec 2019 (actual)
Study completion: 16 Dec 2019 (actual)
First posted: 29 May 2018 (actual)
Results: Posted 18 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Buspirone	Experimental	Drug: BuspironeThese subjects will receive buspirone prior to engaging in the driving simulation.
Unmedicated	Experimental	Drug: BuspironeThese subjects will take no medication prior to engaging in the driving simulation

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder
Has a valid Driver's License

Key exclusion criteria (7 listed)

Major sensorimotor handicaps (e.g. deafness, blindness)
Individuals who have never held a valid driver's license
Intellectual Deficiency (Verbal Comprehension Index < 80)
Inadequate command of the English language
Subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BuspironeBuspirone is an atypical anxiolytic medication.	Drug	Buspirone, Unmedicated

Primary outcome

Driving Performance - Measured by Mean Off-Road Glance Duration
Time frame: Up to 6 weeks
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.
Heart Rate
Time frame: Up to 6 weeks
Hyperarousal will be measured by heart rate during participants' time in the driving simulation.

Results and safety

Results posted to the registry on 18 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2	13	12
No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2	13	12

Primary outcome: Driving Performance - Measured by Mean Off-Road Glance Duration

Time frame: Up to 6 weeks. Mean (Standard Deviation). Unit: Seconds

Measure	Buspirone n = 21	Unmedicated n = 21
Value	0.85 (0.17)	0.90 (0.27)

Primary outcome: Heart Rate

Time frame: Up to 6 weeks. Mean (Standard Deviation). Unit: Beats Per Minute

Measure	Buspirone n = 24	Unmedicated n = 24
Value	81.78 (10.67)	82.74 (11.70)

Adverse events

Time frame: Adverse event data was collected for each participant between the date the participant enrolled in the study and the date the participant completed the study. The precise time frame of this window differed by participant depending on their availability to schedule the driving simulations. On average, adverse event data were collected over a period of 7.2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buspirone	0 of 26 (0%)	5 of 26 (19.2%)	0 of 26
Unmedicated	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Autism Spectrum Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Buspirone in people with Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Driving Performance - Measured by Mean Off-Road Glance Duration (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03538431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.