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Dasotraline Pediatric Extension Study

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ClinicalTrials.gov Identifier: NCT02457819
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : January 10, 2018
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 : 330 participants
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 AEs (or SAEs), and AEs (or SAEs) leading to discontinuation [ Time Frame: 26 Weeks ]

Secondary Outcome Measures :
  1. Clinical laboratory evaluations (serum chemistry) [ Time Frame: 26 Weeks ]
  2. Clinical laboratory evaluations (hematology) [ Time Frame: 26 Weeks ]
  3. Clinical laboratory evaluations (lipid panel) [ Time Frame: 26 Weeks ]
  4. Clinical laboratory evaluations (thyroid function panel) [ Time Frame: 26 Weeks ]
  5. Clinical laboratory evaluations (urinalysis) [ Time Frame: 26 Weeks ]
  6. Clinical laboratory evaluations (sex hormones) [ Time Frame: 26 Weeks ]
  7. Clinical evaluations (physical examination) [ Time Frame: 26 weeks ]
  8. Clinical evaluations (vital signs) [ Time Frame: 26 weeks ]
  9. Clinical evaluations (body height and weight) [ Time Frame: 26 weeks ]
  10. Clinical evaluations (Tanner Staging) [ Time Frame: 26 weeks ]
  11. Clinical evaluations (12 lead ECG) [ Time Frame: 26 weeks ]
  12. Frequency and severity of suicidal ideation using the C SSRS. [ Time Frame: 26 Weeks ]
  13. Frequency and severity of suicidal behavior using the C SSRS. [ Time Frame: 26 Weeks ]
  14. Change in ADHD RS IV HV total score. [ Time Frame: 26 Weeks ]
  15. Change in the inattentiveness and hyperactivity subscales of the ADHD RS IV HV. [ Time Frame: 26 Weeks ]
  16. Change in CGI S score. [ Time Frame: 26 weeks ]
  17. Change in Conners 3 P total score and subscale scores (Oppositional, Cognitive problems, Hyperactivity, and ADHD Index). [ Time Frame: 26 Weeks ]
  18. Change in CSHQ total score and 8 subscale scores (bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness). [ Time Frame: 26 Weeks ]
  19. Change in WFIRS-P total score and 6 domain scores (family, school learning behavior, life skills, child's self-concept, social activities, and risky activities). [ Time Frame: 26 Weeks ]
  20. Assess potential withdrawal symptoms following discontinuation of dasotraline using the following assessments DESS scale and the PWC [ Time Frame: 26 Weeks ]


Information from the National Library of Medicine

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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


  Show 36 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Dasotraline Medical Director Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02457819     History of Changes
Other Study ID Numbers: SEP360-310
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
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
Signs and Symptoms