Dasotraline Binge Eating Disorder Extension Study



Status:Active, not recruiting
Conditions:Psychiatric, Psychiatric, Psychiatric, Eating Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 56
Updated:12/20/2018
Start Date:February 29, 2016
End Date:June 30, 2019

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An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults With Binge-eating Disorder

Binge Eating Disorder Extension Study.

This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults
with Binge Eating Disorder.

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.
We found this trial at
57
sites
Orlando, Florida 32806
Principal Investigator: Linda Harper
Phone: 407-425-5100
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One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
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1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Principal Investigator: Americo Padilla, MD
Phone: 305-279-0015
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Akron, Ohio 44311
Phone: 330-252-1500
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Allentown, Pennsylvania 18104
Principal Investigator: Paul Gross
Phone: 610-820-0342
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Alpharetta, Georgia 30005
Phone: 770-817-9200
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Anderson, South Carolina 29621
Phone: 864-261-9563
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Atlanta, Georgia 30342
Phone: 404-851-9934
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Austin, Texas 78737
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115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
Phone: 617-855-2911
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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436 North Roxbury Drive
Beverly Hills, California 90210
Phone: 424-284-3171
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Boston, Massachusetts 02135
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Cincinnati, Ohio 45242
Principal Investigator: Janell Lundgren
Phone: 513-791-7760
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Colorado Springs, Colorado 80910
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160 West Street
Cromwell, Connecticut 06416
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Dayton, Ohio 45408
Phone: 937-424-1050
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Denver, Colorado 80209
Phone: 720-941-9363
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Encino, California 91316
Phone: 818-705-7451
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Fort Myers, Florida 33912
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Garden Grove, California 92845
Phone: 714-799-7799
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Greer, South Carolina 29650
Principal Investigator: William Ellison
Phone: 864-877-9239
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Herndon, Virginia 20170
Phone: 703-787-9090
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Houston, Texas
Principal Investigator: Shonna Piegari
Phone: 713-838-2022
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Indianapolis, Indiana 46260
Phone: 317-229-6202
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Jacksonville, Florida 32216
Principal Investigator: John Mark Joyce, MD
Phone: 904-281-5757
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Libertyville, Illinois 60048
Principal Investigator: Michael Greenbaum
Phone: 847-549-7214
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Marietta, Georgia 30060
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Mason, Ohio
Phone: 513-536-4673
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6401 Poplar Avenue
Memphis, Tennessee 38119
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Methuen, Massachusetts 01844
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Mount Kisco, New York 10549
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Mount Pleasant, South Carolina 29464
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Murray, Utah 84123
Phone: 801-261-8930
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Nashville, Tennessee 37203
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New York, New York 10128
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New York, New York 10022
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Newport Beach, California 92660
Phone: 949-752-7936
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North Miami, Florida 33161
Principal Investigator: Scott Segal
Phone: 305-722-8444
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Oklahoma City, Oklahoma 73103
Phone: 405-235-8188
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Phoenix, Arizona 85032
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Plano, Texas 75093
Phone: 972-267-1988
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Portland, Oregon 97214
Principal Investigator: Beal Essink
Phone: 503-276-6224
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Portsmouth, New Hampshire 03801
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7301 Mission Road
Prairie Village, Kansas 66208
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Princeton, New Jersey 08540
Phone: 609-921-3555
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Wayne Harper
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Salem, Oregon 97301
Phone: 509-540-0100
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8122 Datapoint Drive
San Antonio, Texas 78229
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San Marcos, California 92078
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Santa Ana, California 92705
Phone: 714-542-3008
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Seattle, Washington 98104
Phone: 206-624-4587
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Watertown, Massachusetts
Principal Investigator: Daniel Rutrick
Phone: 617-744-8542
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Wichita, Kansas 67226
Phone: 316-425-6333
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Woodstock, Vermont 05091
Phone: 802-457-4904
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