Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03231800 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
A Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
- 8
- Study locations
NCT03231800: Completed Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Sumitomo Pharma America.
NCT03231800 is a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Sumitomo Pharma America. The registered enrollment target is 95 participants, below the 136-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (30% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03231800, a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG dasotraline
Study Locations (8)
Florida
- Meridien Research - Bradenton
- Meridien Research - Maitland
- Qps-Mra, Llc - South Miami
California
- Avida Inc - Newport Beach
Massachusetts
- South Shore Psychiatric Services PC - Hingham
Nevada
- Center for Psychiatry and Behavioral Medicine, Inc - Las Vegas
Texas
- Bayou City Research, Ltd - Houston
Utah
- Ericksen Reasearch and Development - Clinton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2019-03-15 |
| Phase | Phase 3 |
What the finished NCT03231800 record still lists
NCT03231800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 136-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03231800 lists 8 locations in 6 states (Florida, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03231800 about?
NCT03231800 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.". 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.
What is the current status of trial NCT03231800?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2017-07-31. Estimated completion is 2019-03-15.
What conditions does trial NCT03231800 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD).
What interventions are being tested in trial NCT03231800?
The interventions under investigation include: Placebo (DRUG), dasotraline (DRUG).
Who is sponsoring clinical trial NCT03231800?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03231800 being conducted?
This trial has 8 study locations across California, Florida, Massachusetts, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Attention Deficit Hyperactivity Disorder (ADHD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03231800's enrollment target sits among peer trials
95 11th of 18 higher than 8 of 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder (ADHD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)
COMPLETED · Phase 3
-
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
COMPLETED · Phase 3
-
PRC-063 in an ADULT Workplace Environment
COMPLETED · Phase 3
-
Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
COMPLETED · Phase 3
-
Improving ADHD Teen Driving - Virtual Reality
RECRUITING · NA
-
Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Heterogeneity in ADHD
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03339128 · 95 participants · Phase 2
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
- NCT03509961 · 95 participants · Phase 2
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
- NCT03694756 · 95 participants · NA
TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer
- NCT04206215 · 95 participants · NA
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI