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
New York, New York 10128
183
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New York, NY
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One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
264
mi
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Cherry Hill, NJ
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1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
2599
mi
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Medford, OR
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1763
mi
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San Antonio, TX
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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...
1263
mi
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South Miami, FL
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Akron, Ohio 44311
Phone: 330-252-1500
544
mi
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Akron, OH
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Allentown, Pennsylvania 18104
Principal Investigator: Paul Gross
Phone: 610-820-0342
259
mi
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Allentown, PA
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Alpharetta, Georgia 30005
Phone: 770-817-9200
910
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Alpharetta, GA
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Anderson, South Carolina 29621
Phone: 864-261-9563
826
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Anderson, SC
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Atlanta, Georgia 30342
Phone: 404-851-9934
927
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Atlanta, GA
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Austin, Texas 78737
1700
mi
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Austin, TX
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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...
4
mi
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Belmont, MA
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436 North Roxbury Drive
Beverly Hills, California 90210
Phone: 424-284-3171
2596
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Beverly Hills, CA
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Boston, Massachusetts 02135
2
mi
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Boston, MA
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Cincinnati, Ohio 45242
Principal Investigator: Janell Lundgren
Phone: 513-791-7760
725
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Cincinnati, OH
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Colorado Springs, Colorado 80910
1773
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160 West Street
Cromwell, Connecticut 06416
96
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Cromwell, CT
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Dayton, Ohio 45408
Phone: 937-424-1050
706
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Denver, Colorado 80209
Phone: 720-941-9363
1762
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Denver, CO
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Encino, California 91316
Phone: 818-705-7451
2599
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Fort Myers, Florida 33912
1252
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Garden Grove, California 92845
Phone: 714-799-7799
2585
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Greer, South Carolina 29650
Principal Investigator: William Ellison
Phone: 864-877-9239
792
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Greer, SC
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Herndon, Virginia 20170
Phone: 703-787-9090
403
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Herndon, VA
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Houston, Texas
Principal Investigator: Shonna Piegari
Phone: 713-838-2022
1601
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Houston, TX
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Indianapolis, Indiana 46260
Phone: 317-229-6202
801
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Indianapolis, IN
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Jacksonville, Florida 32216
Principal Investigator: John Mark Joyce, MD
Phone: 904-281-5757
1016
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Libertyville, Illinois 60048
Principal Investigator: Michael Greenbaum
Phone: 847-549-7214
859
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Libertyville, IL
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Marietta, Georgia 30060
931
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Mason, Ohio
Phone: 513-536-4673
719
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6401 Poplar Avenue
Memphis, Tennessee 38119
1124
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Memphis, TN
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Methuen, Massachusetts 01844
25
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Methuen, MA
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Mount Kisco, New York 10549
157
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Mount Kisco, NY
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Mount Pleasant, South Carolina 29464
813
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Murray, Utah 84123
Phone: 801-261-8930
2094
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Nashville, Tennessee 37203
940
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New York, New York 10022
185
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Newport Beach, California 92660
Phone: 949-752-7936
2582
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North Miami, Florida 33161
Principal Investigator: Scott Segal
Phone: 305-722-8444
1249
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Oklahoma City, Oklahoma 73103
Phone: 405-235-8188
1489
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Oklahoma City, OK
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Orlando, Florida 32806
Principal Investigator: Linda Harper
Phone: 407-425-5100
1115
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Phoenix, Arizona 85032
2283
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Plano, Texas 75093
Phone: 972-267-1988
1533
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Portland, Oregon 97214
Principal Investigator: Beal Essink
Phone: 503-276-6224
2530
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Portland, OR
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Portsmouth, New Hampshire 03801
51
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7301 Mission Road
Prairie Village, Kansas 66208
1250
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Prairie Village, KS
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Princeton, New Jersey 08540
Phone: 609-921-3555
231
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Princeton, NJ
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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...
606
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Raleigh, NC
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1044
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Saint Charles, MO
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Salem, Oregon 97301
Phone: 509-540-0100
2555
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8122 Datapoint Drive
San Antonio, Texas 78229
1762
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San Marcos, California 92078
2562
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Santa Ana, California 92705
Phone: 714-542-3008
2579
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Seattle, Washington 98104
Phone: 206-624-4587
2483
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Watertown, Massachusetts
Principal Investigator: Daniel Rutrick
Phone: 617-744-8542
4
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Wichita, Kansas 67226
Phone: 316-425-6333
1418
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Woodstock, Vermont 05091
Phone: 802-457-4904
112
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Woodstock, VT
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