Dasotraline Pediatric Extension Study

An Open-label, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Dasotraline

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.

• Study Type: Interventional
• Enrollment (Actual): 237
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Harmonex Neuroscience Research, Inc
  • California
    • Culver City, California, United States, 90230
      • Proscience Research Group
    • Wildomar, California, United States, 92595
      • Elite Clinical Trials, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers, LLC
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33012
      • Indago Research Health Center, Inc.
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • South Miami, Florida, United States, 33143
      • Miami Research Associates, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
  • Illinois
    • Libertyville, Illinois, United States, 60418
      • Capstone Clinical Research
    • Naperville, Illinois, United States, 630-896-3530
      • Baber Research Group, Inc.
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Goldpoint Clinical Research, LLC.
    • Newburgh, Indiana, United States, 47630
      • Pedia Research,LLC
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Pedia Research,LLC
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Neurobehavioral Medicine Group, Clinical Trials Division
    • Rochester Hills, Michigan, United States, 48307
      • Clinical Trials group at the Rochester Center for Behavioral Medicine
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates - Midwest Research Group
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry and Behavioral Medicine, Inc.
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Pharmaceutical Research Associates, Inc.
  • New York
    • Staten Island, New York, United States, 10312
      • Richarmond Behavioral Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
    • Oklahoma City, Oklahoma, United States, 73116
      • Cutting Edge Research Group
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • BioBehavioral Research of Austin P.C.
    • Houston, Texas, United States, 77007
      • Bayou City Research, Ltd.
    • Houston, Texas, United States, 77098
      • Houston Clinical Trials, LLC
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78258
      • Road Runner Research, Ltd.
    • The Woodlands, Texas, United States, 77381
      • Family Psychiatry of The Woodlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dasotraline; Dasotraline 2, 4, 6 mg	Drug: Dasotraline; Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.	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).	26 Weeks
Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.	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.	26 weeks

Collaborators and Investigators

• Sponsor: Sunovion
• Investigators: Study Director: Dasotraline Medical Director, Sunovion

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2015
• Primary Completion (Actual): February 2, 2017
• Study Completion (Actual): February 2, 2017

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: SEP360-310