Dasotraline Binge Eating Disorder Extension Study
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Intervention: Dasotraline
Intervention description: Dasotraline 4, 6, 8 mg flexibly dosed once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: open-label
Enrollment: 533.0
Sex: All
Minimum age: 18 Years
Maximum age: 56 Years
Healthy volunteers: No

Summary:

      Binge Eating Disorder Extension Study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the treatment period of a dasotraline core study (ie, SEP360 221 or
             SEP360-321) for the treatment of BED.

          -  Subject has agreed to participate by providing written informed consent and is willing
             and able to comply with the protocol, in the opinion of the investigator.

          -  Subject has not taken any medication other than the study drug for the purpose of
             controlling BED symptoms during the core study.

          -  Female subject must have a negative urine pregnancy test at open label (OL) Baseline;
             females who are post-menopausal (defined as at least 12 months of spontaneous
             amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will
             be exempted from the pregnancy test.

          -  Female subject of childbearing potential and male subject with female partner of
             childbearing potential must agree to use an effective and medically acceptable form of
             birth control (see Section 22, Appendix III) throughout the study period. Note:
             Continued use of an effective and medically acceptable form of birth control is
             recommended for 30 days after study completion.

          -  Subject is judged by the investigator to be suitable for participation in a 12 month
             clinical trial involving open-label dasotraline treatment.

          -  Subject can read well enough to understand the informed consent form and other subject
             materials.

        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 is considered a suicide risk in the investigator's opinion or has any previous
             history of suicide attempt within the past 12 months.

          -  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) on the C SSRS assessment at OL Baseline. Subjects who answer
             "yes" to this question must be referred to the Investigator for follow up evaluation.

          -  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 is breastfeeding.

          -  Subject is at high risk of non-compliance in the investigator's opinion.