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Adult Attention Deficit Hyperactivity DisorderPhase 3NCT02160262

Open-label Safety Study in Adults With ADHD

A Phase 3 study testing Dasotraline in people with Adult Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 years
What is being tested?
Dasotraline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
724 participants
Where
65 sitesUnited States
Study dates
Jun 2014to May 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Institute for Advanced Medical Research

    Alpharetta, Georgia, 30005

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205

  • Southern California Research LLC

    Beverly Hills, California, 90210

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Florida Clinical Research Center LLC

    Bradenton, Florida, 34208

  • Neuro-Behavioral Clinical Research

    Canton, Ohio, 44718

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • MCB Clinical Research Centers, LLC

    Colorado Springs, Colorado, 80910

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Pillar Clinical Research, LLC

    Dallas, Texas, 75243

  • Midwest Clinical Research Center

    Dayton, Ohio, 32350

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Pharmacology Research Institute

    Encino, California, 91316

  • Synergy Clinical Research of Escondido

    Escondido, California, 92025

  • Gulfcoast Clinical Research

    Fort Myers, Florida, 33912

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • NeuroScience, Inc

    Herndon, Virginia, 20170

  • Broward Research Group, Inc.

    Hollywood, Florida, 33026

  • Houston Clinical Trials, LLC

    Houston, Texas, 77098

  • Goldpoint Clinical Research

    Indianapolis, Indiana, 46260

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Geroge M. Joseph MD, PA

    Jacksonville Beach, Florida, 32350

  • Alpine Clinic

    Lafayette, Indiana, 47905

  • Lake Charles Clinical Trials LLC

    Lake Charles, Louisiana, 70601

  • Center for Psychiatry and Behavioral Medicine, Inc.

    Las Vegas, Nevada, 89128

  • Compass Research North, LLC

    Leesburg, Florida, 34748

  • Premeir Psychiatric Research Institute, LLC

    Lincoln, Nebraska, 68526

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Acumentality

    Melbourne, Florida, 32901

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119

  • Research Strategies of Memphis, LLC

    Memphis, Tennessee, 38119

  • Dean Foundation

    Middleton, Wisconsin, 53562

  • Eastside Therapeutic Resource

    Middleton, Wisconsin, 53562

  • Bioscience Research

    Mount Kisco, New York, 10549

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Village Clinical Research Inc.

    New York, New York, 10003

  • NYU School of Medicine

    New York, New York, 10016

  • Medical & Behavioral Health Research

    New York, New York, 10023

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Fieve Clinical Research

    New York, New York, 10168

  • Keystone Clinical Studies, LLC

    Norristown, Pennsylvania, 19403

  • Psychiatric Care & Research Center

    O'Fallon, Missouri, 63368

  • Excell Research, Inc

    Oceanside, California, 92056

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Psychiatric Associates

    Overland Park, Kansas, 90720

  • Summit Research Network

    Portland, Oregon, 97210

  • Oregon Center for Clinical Investigations, Inc.

    Portland, Oregon, 97214

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • Midwest Research Group

    Saint Charles, Missouri, 63304

  • Clinical Trials of Texas, Inc

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Carman Research

    Smyrna, Georgia, 30080

  • Woodhull Medical & Mental Health Center

    Staten Island, New York, 10305

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Family Psychiatry of the Woodlands

    The Woodlands, Texas, 77381

  • Sleep Diagnosists and Treatment Centers

    West Chester, Pennsylvania, 19380

  • Neuropsychiatric Associates

    Woodstock, Vermont, 05091

Other trials in United States

About this study

Official title: 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)

Read the 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

Being tested
Dasotraline
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasotralineDrug

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

Study groups in NCT02160262
Study groupRoleWhat they receive
DasotralineExperimentalDasotraline 4 mg, 6 mg, 8 mg, flexibly dosed
Receives: Drug: Dasotraline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Secondary outcomes (14)

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

    Measured: 12 Months

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

    Measured: 12 months

  3. Drug Effects Questionnaire (DEQ)

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

  6. Change from baseline in Clinical Global Impression - Severity (CGI S) score

    Measured: 12 months

  7. Change from baseline in the ADHD RS IV with adult prompts inattentiveness and hyperactivity-impulsivity subscale scores

    Measured: 12 months

  8. 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)

    Measured: 12 months

  9. Change from baseline in Sheehan Disability Scale (SDS) total score

    Measured: 12 months

  10. Change from baseline in Sheehan Disability Scale (SDS) domain scores: work/school, family life, social life

    Measured: 12 months

  11. 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.

    Measured: 12 months

  12. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores.

    Measured: 12 months

  13. Change from baseline in BRIEF-A Global Executive Composite T-score and BRI T-score and MI T-score.

    Measured: 12 months

  14. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
724 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160262
Sponsor's protocol ID
SEP360-304
Status last verified
May 2017
First submitted
8 Jun 2014
Last updated
2 May 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dasotraline in people with Adult Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of AEs (or SAEs), and AEs (or SAEs) leading to discontinuation. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02160262.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.

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