Open-label Safety Study in Adults With ADHD

NCT02160262 | Completed Phase 3 DMC

• 1 other identifier: SEP360-304
• Study Type: interventional
• Target: 724
• Locations: 1 country
• Sites: 65

Brief Summary

To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with Attention Deficit Hyperactivity Disorder (ADHD)

Conditions

Adult Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• The incidence of AEs (or SAEs), and AEs (or SAEs) leading to discontinuation.

  12 months

Secondary Outcomes (14)

• Clinical evaluations (vital signs, physical examination, body weight, and 12 lead ECG)

  12 Months

• Clinical laboratory evaluations (serum chemistry, hematology, lipid panel, thyroid panel, and urinalysis)

  12 months

• Drug Effects Questionnaire (DEQ)

  12 months

• Frequency and severity of suicidal ideation and suicidal behavior using the Columbia - Suicide Severity Rating Scale (C SSRS)

  12 months

• Change from baseline in ADHD RS IV with adult prompts total score

  12 months

Study Arms (1)

Dasotraline

EXPERIMENTAL

Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed

Drug: Dasotraline

Interventions

Dasotraline DRUG

Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed, once daily

Dasotraline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject meets DSM 5 criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) established by a comprehensive psychiatric evaluation that reviews DSM 5 criteria. Diagnosis is confirmed by CAADID Part 2 with checklist for DSM 5.
• Subject has an ADHD RS IV with adult prompts score of ≥ 22 at screening and baseline.
• 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 is 18 to 55 years old, inclusive, at the time of informed consent.
• Subject is male or a non-pregnant, non lactating female.
• Female subjects must have a negative serum pregnancy test; 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 subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period.
• Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug at screening.
• 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.

You may not qualify if:

• Subject has a psychiatric disorder other than ADHD that has been the primary focus of treatment at any time during the 12 months prior to screening.
• Subject has a past history of, or current presentation consistent with, bipolar disorder (including bipolar I and bipolar II), schizophrenia, schizoaffective disorder, or any other psychotic disorder, or a personality disorder per DSM 5 criteria.
• Subject has a history of substance abuse or drug dependence (excluding nicotine and caffeine) within the 12 months prior to screening, as defined by the DSM 5 criteria.
• Subject has a history of epilepsy, seizures (except childhood febrile seizures), unexplained syncope or other unexplained blackouts (except single incident), or head trauma with loss of consciousness lasting more than 5 minutes.
• Subject has a currently active medical condition (other than ADHD) that, in the opinion of the investigator, could interfere with the ability of the subject to participate in the study.
• Subject is currently taking or has taken within the previous 6 months an anticonvulsant medication (eg, phenytoin, carbamazepine, lamotrigine, valproic acid, etc); antipsychotic medication; or lithium (any lithium preparation or formulation).
• Subject is currently taking an alpha 2 adrenergic receptor agonist (including clonidine and guanfacine), or serotonin-norepinephrine reuptake inhibitor (SNRI; eg, venlafaxine), or dopamine-norepinephrine reuptake inhibitor (DNRI; eg, bupropion), or monoamine oxidase \[MAO\] inhibitor. Note: Subjects who discontinue these medications and wash-out from them for a minimum of 7 days prior to the first dose of study drug will be allowed to enroll in the study.
• Subject is currently undergoing Cognitive Behavioral Therapy (CBT).
• Subject has a Body Mass Index (BMI) less than 18 or greater than 35 kg/m2 (see Appendix V).
• 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 screening (in the past month). Subjects who answer "yes" to this question must be referred to the investigator for follow up evaluation.
• Subject has attempted suicide within 1 year prior to the screening period.
• Subject has history of positive test for Hepatitis B surface antigen or Hepatitis C antibody and has liver function test results at screening above the upper limit of normal for the reference lab.
• Subject is known to have tested positive for human immunodeficiency virus (HIV).
• Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the investigator considers to be inappropriate to allow participation in the study.
• The subject's screening ECG shows a corrected QT interval using Fridericia's formula (QTcF) of ≥ 450 msec for male subjects or ≥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (65)

Southern California Research LLC

Beverly Hills, California, 90210, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Synergy Clinical Research of Escondido

Escondido, California, 92025, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Excell Research, Inc

Oceanside, California, 92056, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Florida Clinical Research Center LLC

Bradenton, Florida, 34208, United States

Location

Gulfcoast Clinical Research

Fort Myers, Florida, 33912, United States

Location

Broward Research Group, Inc.

Hollywood, Florida, 33026, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Geroge M. Joseph MD, PA

Jacksonville Beach, Florida, 32350, United States

Location

Compass Research North, LLC

Leesburg, Florida, 34748, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Acumentality

Melbourne, Florida, 32901, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30005, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Goldpoint Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Alpine Clinic

Lafayette, Indiana, 47905, United States

Location

Psychiatric Associates

Overland Park, Kansas, 90720, United States

Location

Lake Charles Clinical Trials LLC

Lake Charles, Louisiana, 70601, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Psychiatric Care & Research Center

O'Fallon, Missouri, 63368, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Premeir Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Bioscience Research

Mount Kisco, New York, 10549, United States

Location

Village Clinical Research Inc.

New York, New York, 10003, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Medical & Behavioral Health Research

New York, New York, 10023, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Fieve Clinical Research

New York, New York, 10168, United States

Location

Woodhull Medical & Mental Health Center

Staten Island, New York, 10305, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Neuro-Behavioral Clinical Research

Canton, Ohio, 44718, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 32350, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, 97214, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Keystone Clinical Studies, LLC

Norristown, Pennsylvania, 19403, United States

Location

Sleep Diagnosists and Treatment Centers

West Chester, Pennsylvania, 19380, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Research Strategies of Memphis, LLC

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

Houston Clinical Trials, LLC

Houston, Texas, 77098, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Family Psychiatry of the Woodlands

The Woodlands, Texas, 77381, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

NeuroScience, Inc

Herndon, Virginia, 20170, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Dean Foundation

Middleton, Wisconsin, 53562, United States

Location

Eastside Therapeutic Resource

Middleton, Wisconsin, 53562, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• SEP289 Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2014
• First Posted: June 10, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-05

Locations

US (65)