Clinical trial NCT02457819: Dasotraline Pediatric Extension Study
Official title: An Open-label, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-29
Enrollment: 237
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
timeFrame: 26 Weeks
Secondary outcomes:
measure: Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.
timeFrame: 26 Weeks
measure: Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research, Inc
state: Alabama
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Indago Research Health Center, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC.
state: Indiana
city: Newburgh
country: United States
facility: Pedia Research,LLC
state: Indiana
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Owensboro
country: United States
facility: Pedia Research,LLC
state: Kentucky
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group, Clinical Trials Division
state: Michigan
city: Rochester Hills
country: United States
facility: Clinical Trials group at the Rochester Center for Behavioral Medicine
state: Michigan
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Marlton
country: United States
facility: Pharmaceutical Research Associates, Inc.
state: New Jersey
city: Staten Island
country: United States
facility: Richarmond Behavioral Associates
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: BioBehavioral Research of Austin P.C.
state: Texas
city: Houston
country: United States
facility: Bayou City Research, Ltd.
state: Texas
city: Houston
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of the Woodlands
state: Texas
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Dasotraline Medical Director
role: STUDY_DIRECTOR
References: