Dasotraline Pediatric Extension Study

Completed · Phase 3

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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

Key facts

Study ID

NCT02457819

Run by

Sumitomo Pharma America, Inc.

People needed

237

Starts

2015-06-30

Expected to finish

2017-02-02

Last updated by the study team

2020-01-28

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Harmonex Neuroscience Research, Inc — Dothan, Alabama, United States
• ProScience Research Group — Culver City, California, United States
• Elite Clinical Trials, Inc. — Wildomar, California, United States
• MCB Clinical Research Centers, LLC — Colorado Springs, Colorado, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Indago Research Health Center, Inc. — Hialeah, Florida, United States
• Clinical Neuroscience Solutions, Inc — Jacksonville, Florida, United States
• Florida Clinical Research Center, LLC — Maitland, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Miami Research Associates, LLC — South Miami, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Baber Research Group, Inc. — Naperville, Illinois, United States
• Goldpoint Clinical Research, LLC. — Indianapolis, Indiana, United States
• Pedia Research,LLC — Newburgh, Indiana, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Pedia Research,LLC — Owensboro, Kentucky, United States
• Neurobehavioral Medicine Group, Clinical Trials Division — Bloomfield Hills, Michigan, 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
• Center for Psychiatry and Behavioral Medicine, Inc. — Las Vegas, Nevada, United States
• Pharmaceutical Research Associates, Inc. — Marlton, New Jersey, United States
• Richarmond Behavioral Associates — Staten Island, New York, United States
• University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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