Dasotraline Pediatric Extension Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Dasotraline
Intervention description: Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 237.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

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

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.