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Dasotraline Pediatric ADHD Study

NCT02428088 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2021-03-18

No results posted yet for this study

Summary

This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Dasotraline

Dasotraline 2 mg once daily

DRUG

Dasotraline

Dasotraline 4 mg once daily

DRUG

Placebo Comparator

Placebo once daily

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Dasotraline Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT02428088 on ClinicalTrials.gov