Dasotraline Binge Eating Disorder Extension Study

• Status: Completed
• Trial end date: 2019-06-24
• Target enrollment: 0
• Participant gender: All

Summary

Binge Eating Disorder Extension Study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion

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.