Open-label Safety Study in Adults With ADHD

May 1, 2017 updated by: Sunovion

A Phase 3, 12-Month, Multicenter, Open-label, Flexibly-dosed, Safety Study of SEP 225289 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with ADHD by the incidence of adverse events (AEs; or serious AEs), AEs (or SAEs) leading to discontinuation

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
724

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Southern California Research LLC
      • Encino, California, United States, 91316
        • Pharmacology Research Institute
      • Escondido, California, United States, 92025
        • Synergy Clinical Research of Escondido
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, LLC
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Oceanside, California, United States, 92056
        • Excell Research, Inc
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • MCB Clinical Research Centers, LLC
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center LLC
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Clinical Research
      • Hollywood, Florida, United States, 33026
        • Broward Research Group, Inc.
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Jacksonville Beach, Florida, United States, 32350
        • Geroge M. Joseph MD, PA
      • Leesburg, Florida, United States, 34748
        • Compass Research North, LLC
      • Maitland, Florida, United States, 32751
        • Florida Clinical Research Center, LLC
      • Melbourne, Florida, United States, 32901
        • Acumentality
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Institute for Advanced Medical Research
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Goldpoint Clinical Research
      • Lafayette, Indiana, United States, 47905
        • Alpine Clinic
    • Kansas
      • Overland Park, Kansas, United States, 90720
        • Psychiatric Associates
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Lake Charles Clinical Trials LLC
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Rochester Center for Behavioral Medicine
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Psychiatric Care & Research Center
      • Saint Charles, Missouri, United States, 63304
        • Midwest Research Group
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Premeir Psychiatric Research Institute, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Center for Psychiatry and Behavioral Medicine, Inc.
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Center For Emotional Fitness
    • New York
      • Mount Kisco, New York, United States, 10549
        • Bioscience Research
      • New York, New York, United States, 10128
        • The Medical Research Network, LLC
      • New York, New York, United States, 10168
        • Fieve Clinical Research
      • New York, New York, United States, 10016
        • NYU School of Medicine
      • New York, New York, United States, 10003
        • Village Clinical Research Inc.
      • New York, New York, United States, 10023
        • Medical & Behavioral Health Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
      • Staten Island, New York, United States, 10305
        • Woodhull Medical & Mental Health Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neuro-Behavioral Clinical Research
      • Dayton, Ohio, United States, 32350
        • Midwest Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research Group
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network
      • Portland, Oregon, United States, 97214
        • Oregon Center for Clinical Investigations, Inc.
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
      • Norristown, Pennsylvania, United States, 19403
        • Keystone Clinical Studies, LLC
      • West Chester, Pennsylvania, United States, 19380
        • Sleep Diagnosists and Treatment Centers
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions
      • Memphis, Tennessee, United States, 38119
        • Research Strategies of Memphis, LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research, LLC
      • Houston, Texas, United States, 77098
        • Houston Clinical Trials, LLC
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc
      • The Woodlands, Texas, United States, 77381
        • Family Psychiatry of The Woodlands
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Neuropsychiatric Associates
    • Virginia
      • Herndon, Virginia, United States, 20170
        • Neuroscience, Inc
    • Washington
      • Seattle, Washington, United States, 98104
        • Summit Research Network (Seattle) Llc
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation
      • Middleton, Wisconsin, United States, 53562
        • Eastside Therapeutic Resource

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • The subject's screening serum chemistry results show an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value ≥ 2 times the upper limit of normal (ULN), or a blood urea nitrogen (BUN) value ≥ 1.5 times the ULN for the reference laboratory.
  • Subject is currently participating or has participated in a clinical trial within the last 90 days or has participated in more than 2 clinical trials within the past year. This includes studies using marketed compounds or devices.
  • Subject has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulation.
  • Subject has previously been randomized in a clinical trial of dasotraline.
  • Subject is likely to be noncompliant in the investigator's opinion.
  • Subject is an investigational site staff member or the relative of an investigational site staff member.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Dasotraline
Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed
Drug: Dasotraline
Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed, once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The incidence of AEs (or SAEs), and AEs (or SAEs) leading to discontinuation.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Clinical evaluations (vital signs, physical examination, body weight, and 12 lead ECG)
Time Frame: 12 Months
12 Months
Clinical laboratory evaluations (serum chemistry, hematology, lipid panel, thyroid panel, and urinalysis)
Time Frame: 12 months
12 months
Drug Effects Questionnaire (DEQ)
Time Frame: 12 months
12 months
Frequency and severity of suicidal ideation and suicidal behavior using the Columbia - Suicide Severity Rating Scale (C SSRS)
Time Frame: 12 months
12 months
Change from baseline in ADHD RS IV with adult prompts total score
Time Frame: 12 months
12 months
Change from baseline in Clinical Global Impression - Severity (CGI S) score
Time Frame: 12 months
12 months
Change from baseline in the ADHD RS IV with adult prompts inattentiveness and hyperactivity-impulsivity subscale scores
Time Frame: 12 months
12 months
Change from baseline in AIM A in global domain scores (Performance and Daily Functioning, Impact of Symptoms: Daily Interference, Impact of Symptoms: Bother/Concern, Relationships/Communication, Living with ADHD, and General Well-being)
Time Frame: 12 months
12 months
Change from baseline in Sheehan Disability Scale (SDS) total score
Time Frame: 12 months
12 months
Change from baseline in Sheehan Disability Scale (SDS) domain scores: work/school, family life, social life
Time Frame: 12 months
12 months
Change from baseline in Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF®) A Global Executive Composite raw score and Behavioral Regulation Index (BRI) raw score and Metacognition Index (MI) raw score.
Time Frame: 12 months
12 months
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores.
Time Frame: 12 months
12 months
Change from baseline in BRIEF-A Global Executive Composite T-score and BRI T-score and MI T-score.
Time Frame: 12 months
12 months
Symptoms of withdrawal using Physician Withdrawal Checklist (PWC) scores, Study Medication Withdrawal Questionnaire (SMWQ) scores, Montgomery-Asberg Depression Rating Scale (MADRS) scores, Hamilton Anxiety Rating Scale (HAM-A) scores
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunovion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: SEP289 Medical Director, Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEP360-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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