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Dasotraline Pediatric Extension Study

NCT02457819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2020-01-28

Study results available
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Summary

This is an open label 26 week extension study for subjects who completed SEP360-202.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Dasotraline

Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Dasotraline Medical Director · Sumitomo Pharma America, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-02-02
Completion
2017-02-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02457819 on ClinicalTrials.gov