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Completed Phase 1 Interventional

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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 11:55 AM 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

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
Jul 2014 (Type not available)
Primary completion
Mar 2015 (Actual)
Completion
Mar 2015 (Actual)
Last update posted
Mar 31, 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 31, 2015 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02195167 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →