Dasotraline Pediatric Extension Study

Phase 3

Completed

Conditions: Attention Deficit Hyperactivity Disorder

Interventions: Drug: Dasotraline

Registration Number: NCT02457819

Lead Sponsor: Sumitomo Pharma America, Inc.

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

Detailed Description: This is an open-label, flexibly-dosed, 26 week extension study in children and adolescents with ADHD who have completed 6 weeks of double-blind treatment in the core study (SEP360 202). This study will evaluate the long-term safety and tolerability of dasotraline in this population.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 237

Inclusion Criteria

At least one of the subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
Subject and subject's parent/legal guardian are judged by the investigator to be willing and able to comply with the study procedures and visit schedules.
Subject has completed all required assessments for Week 6 of the core study.
Subject has not taken any medication other than the study drug for the purpose of controlling ADHD symptoms during the core study.
Subject, if female, must not be pregnant or breastfeeding.
Female subject: must be unable to become pregnant (eg, premenarchal, surgically sterile, etc);

-OR-

practice true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken; -OR-
is sexually active and willing to use a medically effective method of birth control from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken.
Male subject must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control, from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken.
Any subject whose weight is less than or equal to 21 kg at the OL Baseline visit should be discussed with the medical monitor prior to enrollment.
Subject and subject's parent/legal guardian must be able to fully comprehend the informed consent/assent form (as applicable), understand all study procedures, and be able to communicate satisfactorily with the Investigator and study coordinator.

Exclusion Criteria

-Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for any lifetime history on the C SSRS Children's "Since Last Visit" assessment at OL Baseline.
Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
Subject or parents/legal guardian has commitments during the study that would interfere with attending study visits.
Subject is at high risk of non-compliance in the investigator's opinion.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dasotraline	Dasotraline	Dasotraline 2, 4, 6 mg

Primary Outcome Measures

Name	Time	Method
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation	26 Weeks	Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.	26 Weeks	The ADHD RS-IV HV is a validated scale that consists of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is also consistent with DSM-5 criteria. Each item is scored from a range of zero (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from zero to 54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17).
Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.	26 weeks	The CGI-S scale, modified captures the clinician's rating of observed and reported ADHD symptoms, behavior, and function over the past 7 days. The CGI-S is rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects.

Trial Locations

Locations (35): Psychiatric Associates
🇺🇸
Overland Park, Kansas, United States
Harmonex Neuroscience Research, Inc
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Dothan, Alabama, United States
Clinical Trials group at the Rochester Center for Behavioral Medicine
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Rochester Hills, Michigan, United States
iResearch Atlanta, LLC
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Decatur, Georgia, United States
Pedia Research,LLC
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Owensboro, Kentucky, United States
Capstone Clinical Research
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Libertyville, Illinois, United States
Florida Clinical Research Center, LLC
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Maitland, Florida, United States
Cyn3rgy Research
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Gresham, Oregon, United States
IPS Research Company
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Oklahoma City, Oklahoma, United States
Goldpoint Clinical Research, LLC.
🇺🇸
Indianapolis, Indiana, United States
Road Runner Research, Ltd.
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San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸
San Antonio, Texas, United States
Center for Psychiatry and Behavioral Medicine, Inc.
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Las Vegas, Nevada, United States
University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience
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Cincinnati, Ohio, United States
MCB Clinical Research Centers, LLC
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Colorado Springs, Colorado, United States
Miami Research Associates, LLC
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South Miami, Florida, United States
Elite Clinical Trials, Inc.
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Wildomar, California, United States
ProScience Research Group
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Culver City, California, United States
Baber Research Group, Inc.
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Naperville, Illinois, United States
Neurobehavioral Medicine Group, Clinical Trials Division
🇺🇸
Bloomfield Hills, Michigan, United States
St. Charles Psychiatric Associates - Midwest Research Group
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Saint Charles, Missouri, United States
Pharmaceutical Research Associates, Inc.
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Marlton, New Jersey, United States
Richarmond Behavioral Associates
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Staten Island, New York, United States
University Hospitals Case Medical Center
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Cleveland, Ohio, United States
Cutting Edge Research Group
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Oklahoma City, Oklahoma, United States
Bayou City Research, Ltd.
🇺🇸
Houston, Texas, United States
Coastal Carolina Research Center
🇺🇸
Mount Pleasant, South Carolina, United States
Houston Clinical Trials, LLC
🇺🇸
Houston, Texas, United States
Family Psychiatry of the Woodlands
🇺🇸
The Woodlands, Texas, United States
Clinical Neuroscience Solutions, Inc
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Jacksonville, Florida, United States
Indago Research Health Center, Inc.
🇺🇸
Hialeah, Florida, United States
Atlanta Center for Medical Research
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Atlanta, Georgia, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Orlando, Florida, United States
BioBehavioral Research of Austin P.C.
🇺🇸
Austin, Texas, United States