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.
CompletedPhase 3Results postedLast updated 27 March 2020
What this trial tests
Phase 3 trial testing dasotraline 4mg in Attention-Deficit Hyperactivity Disorder (ADHD) in 132 participants. Completed in 28 February 2017.
Adults 6 to 12, any sex, with Attention-Deficit Hyperactivity Disorder (ADHD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose)Primary· Baseline to Day 15
The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.
Group
Value
95% CI
Placebo
1.99
± 0.949
Dasotraline 4mg
-3.19
± 0.942
Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)Secondary· Baseline to Day 15
The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Attention Subscale scores for the SKAMP are obtained by summing the values of Items 1-4 in the assessment. The range of SKAMP Attention Subscale score is 0-24, with higher values represent a worse outcome.
Group
Value
95% CI
Placebo
0.79
± 0.281
Dasotraline 4mg
-0.67
± 0.279
Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)Secondary· Baseline to Day 15
The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Deportment Subscale scores for the SKAMP are obtained by summing the values of Items 5-8 in the assessment. The range of SKAMP Deportment Subscale score is 0-24, with higher values represent a worse outcome.
Group
Value
95% CI
Placebo
0.16
± 0.356
Dasotraline 4mg
-1.44
± 0.350
Change From Baseline at Day 15 in Permanent Product Measure of Performance (PERMP)-Attempted and Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)Secondary· Baseline to Day 15
TThe Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
attempted
Group
Value
95% CI
Placebo
-1.07
± 5.871
Dasotraline 4mg
22.60
± 5.780
corrected
Group
Value
95% CI
Placebo
-1.96
± 5.864
Dasotraline 4mg
22.09
± 5.777
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT03107026 — A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sumitomo Pharma America, Inc.
Last refreshed: 27 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02734693.