Clinical Trial: A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of Dasotraline in Children Aged 6 to 12 Years With Attention-Deficit Hyperac
Brief Summary: A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.
Detailed Summary: This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in children with ADHD in a laboratory classroom setting. The study will be comprised of 3 periods: Screening (up to 35 days) including a 3 - 5 day ADHD medication washout prior to Day -1; Double-blind randomized treatment with either dasotraline (4 mg/day) or placebo for14 days; and End of Study (EOS) Visit (7 days after last dose). Prior to the start of treatment (Day 1) and following the conclusion of the double-blind period (Day 15), subjects will undergo a full-day laboratory classroom evaluation during which approximately 12 to 18 subjects will be assessed. Each laboratory classroom day will include seven 30-minute simulated classroom sessions where trained observers will assess subjects using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Scale. In addition during each classroom session, a 10-minute math test (Permanent Product Measure of Performance [PERMP]) will be administered to evaluate sustained attention and effort. Seven (± 2) days after the last dose of study drug, subjects will return to the clinic and complete safety assessments.
Sponsor: Sunovion
Current Primary Outcome: Change from baseline at Day 15 in ADHD symptoms as measured by mean SKAMP-Combined score obtained from an average of the 7 assessments collected across the 12-hour classroom day (12 to 24 hours postdose). [ Time Frame: Baseline to Day 15 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean SKAMP-Combined score from the 7 assessments collected across the 12-hour classroom day (12 to 24 hours postdose) on Day 15 [ Time Frame: Day 15 ]
- SKAMP-Combined score at each of the assessment times (12-, 14-, 16-, 18-, 20-, 22-, and 24-hours postdose) during the classroom day on Day 15 [ Time Frame: Day 15 ]
- Change from baseline at Day 15 in SKAMP-Combined score at each of the assessment times (12-, 14-, 16-, 18-, 20-, 22-, and 24-hours postdose) during the classroom day [ Time Frame: Baseline to Day 15 ]
- Change from baseline at Day 15 in mean SKAMP-Attention subscale score obtained from the 7 assessments collected across the 12-hour classroom day (12 to 24 hours postdose [ Time Frame: Baseline to Day 15 ]
- SKAMP-Attention subscale score at each of the assessment times (12-, 14-, 16-, 18-, 20-, 22-, and 24-hours postdose) during the classroom day on Day 15 [ Time Frame: Day 15 ]
- Change from baseline at Day 15 in SKAMP-Attention subscale score at each of the assessment times (12-, 14-, 16-, 18-, 20-, 22-, and 24-hours postdose) during the classroom day [ Time Frame: Baseline to Day 15 ]
- Change from baseline at Day 15 in mean SKAMP-Deportment subscale score obtained from the 7 assessments collected across the 12-hour classroom day (12 to 24 hours postdose) [ Time Frame: Baseline to Day 15 ]
- SKAMP-Deportment subscale score at each of the assessment times (12-, 14-, 16-, 18-, 20-, 22-, and 24-hours postdose) during the classroom day on Day 15 [ Time Frame: Day 15 ]
- Change from baseline at Day 15 in SKAMP-Deportment subscale score at each of the assessment times (12-, 14-, 16-, 18-, 20-, 22-, and 24-hours postdose) during the classroom day [ Time Frame: Baseline to Day 15 ]
- Change from baseline at Day 15 in Permanent Product Measure of Performance (PERMP)-Attempted and Correct Problems scores at each of the assessment times (12-, 14-, 16-, 18-, 20-, 22-, and 24-hours postdose) during the classroom day [ Time Frame: Baseline to Day 15 ]
- PERMP-Attempted and Correct Problems scores at each of the assessment times (12-, 14-, 16-, 18-, 20-, 22-, and 24-hours postdose) during the classroom day on Day 15 [ Time Frame: Day 15 ]
- Absolute values and change from baseline in clinical laboratory evaluations (serum chemistry) [ Time Frame: Baseline to Day 15 ]
- Absolute values and changes from baseline in vital signs [ Time Frame: Day 15 ]
- Frequency and severity of suicidal ideation and suicidal behavior as assessed by the C-SSRS [ Time Frame: Day 15 ]
- Absolute values and change from baseline in clinical laboratory evaluations (hematology) [ Time Frame: Day 15 ]
- Absolute values and change from baseline in clinical laboratory evaluations (urinalysis) [ Time Frame: Day 15 ]
- Absolute values and change from baseline in body weight [ Time Frame: Day 15 ]
- Absolute values and change from baseline in12-lead ECGs [ Time Frame: Day 15 ]
Original Secondary Outcome: Same as current
Information By: Sunovion
Dates:
Date Received: April 1, 2016
Date Started: April 2016
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017