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)
1 other identifier
interventional
237
1 country
36
Brief Summary
This is an open label 26 week extension study for subjects who completed SEP360-202.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2015
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedStudy Start
First participant enrolled
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2017
CompletedResults Posted
Study results publicly available
January 18, 2020
CompletedJanuary 28, 2020
January 1, 2020
1.6 years
May 20, 2015
January 4, 2020
January 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.
26 Weeks
Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.
26 weeks
Study Arms (1)
Dasotraline
EXPERIMENTALDasotraline 2, 4, 6 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Harmonex Neuroscience Research, Inc
Dothan, Alabama, 36303, United States
ProScience Research Group
Culver City, California, 90230, United States
Elite Clinical Trials, Inc.
Wildomar, California, 92595, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Indago Research Health Center, Inc.
Hialeah, Florida, 33012, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Miami Research Associates, LLC
South Miami, Florida, 33143, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Capstone Clinical Research
Libertyville, Illinois, 60418, United States
Baber Research Group, Inc.
Naperville, Illinois, 630-896-3530, United States
Goldpoint Clinical Research, LLC.
Indianapolis, Indiana, 46260, United States
Pedia Research,LLC
Newburgh, Indiana, 47630, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Pedia Research,LLC
Owensboro, Kentucky, 42301, United States
Neurobehavioral Medicine Group, Clinical Trials Division
Bloomfield Hills, Michigan, 48302, United States
Clinical Trials group at the Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128, United States
Pharmaceutical Research Associates, Inc.
Marlton, New Jersey, 08053, United States
Richarmond Behavioral Associates
Staten Island, New York, 10312, United States
University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
BioBehavioral Research of Austin P.C.
Austin, Texas, 78759, United States
Bayou City Research, Ltd.
Houston, Texas, 77007, United States
Houston Clinical Trials, LLC
Houston, Texas, 77098, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Road Runner Research, Ltd.
San Antonio, Texas, 78258, United States
Family Psychiatry of the Woodlands
The Woodlands, Texas, 77381, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CNS Medical Director
- Organization
- Sunovion Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Dasotraline Medical Director
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2015
First Posted
May 29, 2015
Study Start
June 30, 2015
Primary Completion
February 2, 2017
Study Completion
February 2, 2017
Last Updated
January 28, 2020
Results First Posted
January 18, 2020
Record last verified: 2020-01