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Central Nervous System Stimulant

1 for Attention Deficit Hyperactivity Disorder (ADHD)

N/A
Waitlist Available
Led By Daniel J Cox, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

Among children, attention-deficit/hyperactivity disorder (ADHD) is associated with an increased risk for accidents, especially bicycle and pedestrian (Leibson 2001; Jensen 1988; DiScala 1998). Anywhere from 40% to 80% of children diagnosed with ADHD continue to display symptoms of the disorder into adolescence(Barkley 1990; Gittelman 1985). Adolescents with ADHD are also at an increased risk for driving-related accidents, being 2 to 4 times more likely to experience a motor vehicle accident (Barkley 1993; Barkley 1996; Cox 2000), 4 times as likely to be at fault in the accident (Barkley 1993), and over 3 times more likely to incur associated injuries as a result of the accident(Murphy 1996). Stimulant treatment with immediate-release methylphenidate (IR MPH) has been demonstrated to improve driving performance in adolescents with ADHD. Hypothesis to be Tested: * Main study: Just as stimulant medication improves simulation and on-road driving performance of ADHD teenagers, it is hypothesized that stimulant medication will improve routine driving performance. * Substudy - Extended wear (15 hours) of Daytrana will lead to safer driving late in the evening (22:00 and 01:00), when the most dangerous driving mishaps are most likely to occur, and the next morning at 09:00.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2008 Phase 4 trial • 36 Patients • NCT00586157
43%
Loss of Appetite
33%
Other
30%
Gastro-Intestinal
27%
Insomnia
17%
Irritability
17%
Headaches
13%
Pruritis at site
10%
Rhinitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
MTS (Drug A)
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Daytrana
Group II: 2Active Control1 Intervention
No treatment for ADHD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
FDA approved

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
781 Previous Clinical Trials
1,315,656 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
602 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Daniel J Cox, PhDPrincipal InvestigatorUniversity of Virginia
5 Previous Clinical Trials
375 Total Patients Enrolled
~1 spots leftby Nov 2025