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Norepinephrine-Dopamine Reuptake Inhibitor

Dasotraline 4mg for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3
Waitlist Available
Research Sponsored by Sunovion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 15
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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)
Secondary study objectives
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)
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)
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)

Side effects data

From 2018 Phase 3 trial • 491 Patients • NCT03107026
21%
Dry mouth
21%
Insomnia
12%
Nausea
12%
Headache
9%
Weight decreased
9%
Decreased appetite
9%
Anxiety
7%
Upper respiratory tract infection
6%
Initial insomnia
5%
Dizziness
4%
Constipation
1%
Palpitations
1%
Hiatus hernia
1%
Inguinal hernia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dasotraline 4mg
Dasotraline 6mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dasotraline 4mgExperimental Treatment1 Intervention
Dasotraline capsule 4mg/day
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasotraline
Not yet FDA approved

Find a Location

Who is running the clinical trial?

SunovionLead Sponsor
191 Previous Clinical Trials
50,564 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,496 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Sumitomo Pharma America, Inc.Lead Sponsor
243 Previous Clinical Trials
53,076 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,496 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
CNS Medical DirectorStudy DirectorSunovion Pharamceuticals Inc.
33 Previous Clinical Trials
6,631 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
44 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~14 spots leftby Nov 2025
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