Dasotraline SEP360-105 Pediatric PK/PD Study

ClinicalTrials.gov ID: NCT02195167

Public ClinicalTrials.gov record NCT02195167. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 4, 2026, 9:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Single Oral Doses of SEP-225289 in Subjects 6 to 17 Years of Age With Attention Deficit Hyperactivity Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Pediatric PK study of SEP-225289 (Dasotraline)

Study identification

NCT ID: NCT02195167
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Sumitomo Pharma America, Inc.; Industry
Enrollment: 105 participants

Conditions and interventions

Conditions

Pediatric Attention Deficit Hyperactivity Disorder

Interventions

Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily Drug

Drug

Eligibility (public fields only)

Age range: 6 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 30, 2014
Primary completion: Feb 28, 2015
Completion: Feb 28, 2015
Last update posted: Mar 30, 2015

2014 – 2015

United States locations

U.S. sites: 12
U.S. states: 9
U.S. cities: 10

Facility	City	State	ZIP	Site status
Woodland International Research Group	Little Rock	Arkansas	72211	—
MCB Clinical Research Centers, LLC	Colorado Springs	Colorado	80910	—
Palm Springs Research Institute	Hialeah	Florida	33012	—
Atlanta Center for Medical Research	Atlanta	Georgia	30308	—
iResearch Atlanta, LLC	Decatur	Georgia	30030	—
Louisiana Research Associates, Inc	New Orleans	Louisiana	70114	—
Wake Research	Raleigh	North Carolina	27612	—
IPS Research Company	Oklahoma City	Oklahoma	73103	—
Cutting Edge Research Group	Oklahoma City	Oklahoma	73116	—
Clinical Trials of Texas, Inc. (CTT)	San Antonio	Texas	78229	—
Road Runner Research	San Antonio	Texas	78258	—
Aspen Clinical Research	Orem	Utah	84058	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02195167, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 30, 2015 · Synced Sep 4, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02195167 live on ClinicalTrials.gov.

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