Dasotraline Pediatric Extension Study

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457819
• Other study ID #: SEP360-310
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2015
• Est. completion date: February 2, 2017

Study information

• Verified date: January 2020
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Dasotraline
Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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