NCT00557960CompletedPhase 3
A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Shire
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Overall Driving Safety Score derived by the driving simulator
Study Overview
Brief Summary
Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •primary diagnosis of ADHD
- •not naive to pharmacologic ADHD treatment
- •valid driver's license with a minimum of 3 years driving experience
Exclusion Criteria
- •recent history of drug dependence or substance use disorder
- •any specific cardiac condition that would, in the opinion of the investigator, require exclusion
- •history of seizure in last 2 years, tic disorder or Tourette's disorder
- •female subject is pregnant or lactating
Outcomes
Primary Outcomes
Overall Driving Safety Score derived by the driving simulator
Time Frame: Weeks 3 & 6
Secondary Outcomes
- AEs, laboratory screens, PE, vital signs, ECG(6 weeks)
- Driving Safety Scores at individual time points(2, 7, and 12 hours post-dose at Weeks 3 & 6)
- Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire(Weeks 3 & 6)
Investigators
Study Sites (2)
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