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Dasotraline Pediatric Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02457819
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : January 18, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sunovion

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

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Dasotraline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: An Open-label, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Actual Study Start Date : June 30, 2015
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : February 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dasotraline
Dasotraline 2, 4, 6 mg
Drug: Dasotraline
Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed




Primary Outcome Measures :
  1. The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation [ Time Frame: 26 Weeks ]
    Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.


Secondary Outcome Measures :
  1. Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score. [ Time Frame: 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).


  2. Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457819


Locations
Show Show 36 study locations
Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Dasotraline Medical Director Sunovion
  Study Documents (Full-Text)

Documents provided by Sunovion:
Study Protocol  [PDF] January 20, 2016
Statistical Analysis Plan  [PDF] March 9, 2017

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02457819    
Other Study ID Numbers: SEP360-310
First Posted: May 29, 2015    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 28, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases