Attention Deficit Hyperactivity DisorderPhase 2/3NCT02428088
Dasotraline Pediatric ADHD Study
A Phase 2/3 study testing Dasotraline in people with Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 43 sites in United States.
Trial summary
This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Dasotraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 43 sitesUnited States
- Study dates
- Apr 2015to Jul 2016
- Phase
- Phase 2/3
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
- Subject and the subject's parent/legal guardian must be judged by the investigator to be willing and able to comply with the study procedures and visit schedules.
- Subject, male or female, must be between 6 and 12 years of age, inclusive, at the time of consent/assent and at Baseline.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) at screening established by a comprehensive psychiatric evaluation that reviews DSM 5 criteria is confirmed using the K-SADS-PL at Screening.
- Subject has an ADHD RS IV HV score of ≥ 28.
- Subject has a CGI S score of ≥ 4.
Show all 18Show fewer
- Subject, if female, must not be pregnant or breastfeeding, and if ≥ 8 years of age must have a negative pregnancy test.
- Female subject:
- must be unable to become pregnant (eg, premenarchal, surgically sterile, etc);
- OR
- practice true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken;
- OR
- is sexually active and willing to use a medically effective method of birth control (see Appendix VII) from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken.
- Male subject must be willing to remain sexually abstinent (consistent with lifestyle) or be using an effective method of birth control from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken.
- Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical and neurological examinations, vital signs, medical history, and clinical laboratory values (hematology, chemistry, and urinalysis). Note: If any of the hematology, chemistry, or urinalysis results are not within the laboratory's reference range, then the subject may be included only if the investigator determines the deviations to be not clinically relevant.
- Subject weighs at least 21 kg and is within 3rd to 97th percentile for gender specific body-mass-index (BMI)-for-age from the World Health Organization (WHO) growth charts (see Appendices II and IX).
- Subject's parent/legal guardian must report a history of the subject being able to swallow capsules.
- Subject and subject's parents/legal guardians must be able to fully comprehend the informed consent/assent form (as applicable), understand all study procedures, and be able to communicate satisfactorily with the Investigator and study coordinator.
Who cannot join
- Subject or parent/legal guardian has commitments during the study that would interfere with attending study visits.
- Subject currently has a diagnosis of asthma that has required daily treatment with bronchodilators or nebulizer treatments in the 30 days prior to screening and/or who may require daily treatments with these agents over the course of the trial. Intermittent use of bronchodilators is not exclusionary. Subjects who have a history of requiring persistent asthma treatment should be discussed wit the medical monitor prior to enrolment.
- Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (eg, malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion. Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.
- Subject has a history or presence of abnormal ECGs, which in the investigator's opinion is clinically significant. Screening site ECGs will be centrally over-read, and eligibility will be determined by the investigator based on the results of the over-read report.
- Subject has any documented diagnosis of Bipolar I or II Disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, any history of psychosis, autism spectrum disorder, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. Note: Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment.
- Subject has generalized anxiety disorder that has been the primary focus of treatment at any time during the 12 months prior to screening or that required pharmacotherapy any time in the 6 months prior to screening.
Show all 29Show fewer
- Subject has failed 2 adequate courses of stimulant or non-stimulant treatment for ADHD, as judged by the investigator.
- Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood (eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is exclusionary. Subject taking anticonvulsants for seizure control currently or within the past 2 years is not eligible for study participation.
- Subject has uncontrolled thyroid disorder indicated by free T4, free T3, or thyroid stimulating hormone (TSH) outside the limit of normal for the reference laboratory.
- 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) for any lifetime history on the C SSRS Children's Lifetime/Recent assessment at screening.
- Subject has any history of attempted suicide, in the opinion of the investigator.
- Subject does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
- Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions or has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulations.
- Subject has history of intolerance to stimulants.
- Subject has taken any antipsychotic medication within 8 weeks prior to screening.
- Subject taking any medication, including health food supplements with purported psychotropic activity (for example, St. John's Wort), must have a minimum washout of 7 days prior to Day 1.
- Subject taking any antidepressant medication (eg, bupropion, selective serotonin reuptake inhibitor [SSRI]/ serotonin norepinephrine reuptake inhibitor [SNRI], monoamine oxidase [MAO] inhibitor, tricyclic, etc) must have a minimum washout of 7 days prior to Day 1.
- Subject is currently undergoing Cognitive Behavioral Therapy (CBT) for the treatment of ADHD, has initiated behavioral therapy (including school based interventions) less than 1 month prior to screening, or is receiving behavioral therapy and in the opinion of the investigator will not be able to follow a stable routine for the duration of the study.
- Subject or subject's family anticipates a move outside the geographic range of investigative site during the study period, or plans extended travel inconsistent with the recommended visit interval during study duration.
- Subject has a history of, or current malignancy except for non melanomatous skin cancer.
- 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 laboratory.
- Subject is known to have tested positive for human immunodeficiency virus (HIV).
- Subject has participated in any investigational study within 90 days prior to screening or is currently participating in another clinical trial.
- Subject has a history of substance or alcohol use disorder (excluding caffeine) within the 12 months prior to screening, as defined by the DSM 5 criteria, or is currently using tobacco or other nicotine-containing products, or has a positive urine drug screen (UDS) or breath alcohol test at screening. Note: Subjects with a positive UDS may be allowed to continue in the study, provided that the investigator determines that the positive test is as a result of taking prescription medicine(s) as prescribed.
- Subject requires treatment with any disallowed medications during the study.
- Subject has experienced significant blood loss within 60 days prior to screening.
- Subject has previously been enrolled in a clinical trial of dasotraline (SEP 225289).
- Subject's parent/legal guardian is an investigational site staff member or the relative of an investigational site staff member.
- Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
BioBehavioral Research of Austin P.C.
Austin, Texas, 78759
Hugo W. Moser Research Institute at Kennedy Krieger
Baltimore, Maryland, 21205
Neurobehaviorial Medicine Group, PLLC
Bloomfield Hills, Michigan, 48302
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, 45219
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
Pillar Clinical Research, LLC
Dallas, Texas, 75228
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Harmonex Neuroscience Research
Dothan, Alabama, 36303
Duke University Medical Center - Duke Child and Family Study Center
Durham, North Carolina, 27705
Gulfcoast Clinical Research
Fort Myers, Florida, 33912
Sarkis Clinical Trials - Parent
Gainesville, Florida, 32607
Cyn3rgy Research
Gresham, Oregon, 97030
Palm Springs Research Institute
Hialeah, Florida, 33012
Bayou City Research Corporation
Houston, Texas, 77007
Houston Clinical Trials, LLC
Houston, Texas, 77098
Goldpoint Clinical Research
Indianapolis, Indiana, 46260
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Capstone Clinical Research, Inc.
Libertyville, Illinois, 60048
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
Pharmaceutical Research Associates, Inc.
Marlton, New Jersey, 08053
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Baber Research Group
Naperville, Illinois, 60563
Synergy Research
National City, California, 91950
Pedia Research,LLC
Newburgh, Indiana, 47630
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Aspen Clinical Research
Orem, Utah, 84058
Clinical Neuroscience Solutions
Orlando, Florida, 32806
Psychiatric Associates
Overland Park, Kansas, 66211
Pedia Research,LLC
Owensboro, Kentucky, 42301
California Clinical Trials
Paramount, California, 90723
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
Road Runner Research
San Antonio, Texas, 78258
PCSD-Feighner Research
San Diego, California, 92108
Richmond Behavioral Associates
Staten Island, New York, 10312
Family Psychiatry of The Woodlands, P.A.
The Woodlands, Texas, 77381
Elite Clinical Trials, Inc.
Wildomar, California, 92595
About this study
Official title: A 6-week, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-group Efficacy and Safety Study of Dasotraline Versus Placebo in Subjects 6 to 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD)
This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.
Read the detailed description
This is a randomized, double blind, multicenter, placebo-controlled, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in subjects 6 to 12 years of age with ADHD using 2 doses of dasotraline (2 mg/day and 4 mg/day) versus placebo over a 6 week treatment period. The study will consist of screening, treatment, and end of study visits.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Dasotraline, Placebo Comparator
- 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
Also called SEP-225289
Dasotraline 2 mg once daily
DasotralineDrug
Also called SEP-225289
Dasotraline 4 mg once daily
Placebo ComparatorDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Dasotraline 2 mg | Experimental | Dasotraline 2 mg Receives: Drug: Dasotraline |
| Dasotraline 4 mg | Experimental | Dasotraline 4 mg Receives: Drug: Dasotraline |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at Week 6 in ADHD symptoms as measured by ADHD RS IV HV.
Measured: Baseline, 6 Weeks
Secondary outcomes (25)
Change from baseline in ADHD symptoms as measured by in ADHD RS IV HV at Weeks 1, 2, 3, 4, and 5.
Measured: Baseline, Weeks 1,2,3,4,5
Change from baseline in the inattentiveness and hyperactivity subscales of the ADHD RS IV HV at Weeks 1, 2, 3, 4, 5, and 6.
Measured: Baseline, Weeks 1,2,3,4,5,6
The percentage of responders at Weeks 1, 2, 3, 4, 5, and 6. A responder is defined as a subject with a ≥ 30% improvement in ADHD symptoms compared with baseline as measured by the ADHD RS IV HV.
Measured: Baseline, Weeks 1,2,3,4,5,6
Change from baseline in CGI-S scale at Weeks 1, 2, 3, 4, 5, and 6.
Measured: Baseline, Weeks 1,2,3,4,5,6
Change from baseline in Conners 3 P total score and subscale scores (Oppositional, Cognitive problems, Hyperactivity, and ADHD Index) at Weeks 1, 2, 3, 4, 5, and 6.
Measured: Baseline, Weeks 1,2,3,4,5,6
Change from baseline in Conners 3 T total score at Weeks 3 and 6.
Measured: Baseline, Weeks 3, 6
Change from baseline in WPREMB R total score and subscores at Weeks 1, 2, 3, 4, 5, and 6.
Measured: Baseline, Weeks 1,2,3,4,5,6
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations.
Measured: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (serum chemistry).
Measured: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (hematology).
Measured: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (lipid panel).
Measured: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (thyroid panel).
Measured: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (sex hormones).
Measured: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (urinalysis).
Measured: Baseline, 6 Weeks
Absolute values and changes from baseline in 12 lead ECGs.
Measured: Baseline, 6 Weeks
Absolute values and changes from baseline in vital signs.
Measured: Baseline, 6 Weeks
Absolute values and changes from baseline in body weights.
Measured: Baseline, 6 Weeks
Change from baseline in CSHQ total score and 8 subscale scores (bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness) at Weeks 1, 2, 3, 4, 5, and 6.
Measured: Baseline, Weeks 1,2,3,4,5,6
Change from baseline in Tanner staging at Week 6.
Measured: 6 Weeks
Frequency of suicidal ideation and suicidal behavior as assessed by the C SSRS.
Measured: 6 Weeks
Severity of suicidal ideation and suicidal behavior as assessed by the C SSRS.
Measured: 6 Weeks
Dasotraline plasma concentration for PK at Weeks 2, 4, and 6.
Measured: Baseline, Weeks 2,4,6
Change from baseline in DHPG concentration at Weeks 2, 4, and 6.
Measured: Baseline, Weeks 2,4,6
Change from baseline in NE concentration at Weeks 2, 4, and 6.
Measured: Baseline, Weeks 2,4,6
Change from baseline in WFIRS P total score and 6 domain scores (family, learning and school, life skills, child's self-concept, social activities and risky activities) at Week 3 and 6.
Measured: Baseline, Weeks 3,6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dasotraline Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428088
- Sponsor's protocol ID
- SEP360-202
- Status last verified
- Mar 2021
- First submitted
- 20 Apr 2015
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gumenyuk S, Ogirala A, Szabo ST, Koblan K, Hopkins SC, Ufer M. Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System. Clin Drug Investig. 2026 Apr;46(4):455-465. doi: 10.1007/s40261-026-01525-3. Epub 2026 Feb 16.
PubMed 41697570Findling RL, Adler LA, Spencer TJ, Goldman R, Hopkins SC, Koblan KS, Kent J, Hsu J, Loebel A. Dasotraline in Children with Attention-Deficit/Hyperactivity Disorder: A Six-Week, Placebo-Controlled, Fixed-Dose Trial. J Child Adolesc Psychopharmacol. 2019 Mar;29(2):80-89. doi: 10.1089/cap.2018.0083. Epub 2019 Jan 29.
PubMed 30694697
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-group Efficacy and Safety Study of Dasotraline Versus Placebo in Subjects 6 to 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02428088
- Acronym / sponsor ID
- SEP360-202
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.
Detailed description
This is a randomized, double blind, multicenter, placebo-controlled, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in subjects 6 to 12 years of age with ADHD using 2 doses of dasotraline (2 mg/day and 4 mg/day) versus placebo over a 6 week treatment period. The study will consist of screening, treatment, and end of study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dasotraline 2 mg | Experimental | Drug: DasotralineDasotraline 2 mg |
| Dasotraline 4 mg | Experimental | Drug: DasotralineDasotraline 4 mg |
| Placebo | Placebo comparator | Drug: Placebo ComparatorPlacebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
- Subject and the subject's parent/legal guardian must be judged by the investigator to be willing and able to comply with the study procedures and visit schedules.
- Subject, male or female, must be between 6 and 12 years of age, inclusive, at the time of consent/assent and at Baseline.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) at screening established by a comprehensive psychiatric evaluation that reviews DSM 5 criteria is confirmed using the K-SADS-PL at Screening.
- Subject has an ADHD RS IV HV score of ≥ 28.
Key exclusion criteria (29 listed)
- Subject or parent/legal guardian has commitments during the study that would interfere with attending study visits.
- Subject currently has a diagnosis of asthma that has required daily treatment with bronchodilators or nebulizer treatments in the 30 days prior to screening and/or who may require daily treatments with these agents over the course of the trial. Intermittent use of bronchodilators is not exclusionary. Subjects who have a history of requiring persistent asthma treatment should be discussed wit the medical monitor prior to enrolment.
- Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (eg, malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion. Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.
- Subject has a history or presence of abnormal ECGs, which in the investigator's opinion is clinically significant. Screening site ECGs will be centrally over-read, and eligibility will be determined by the investigator based on the results of the over-read report.
- Subject has any documented diagnosis of Bipolar I or II Disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, any history of psychosis, autism spectrum disorder, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. Note: Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasotralineAlso: SEP-225289Dasotraline 2 mg once daily | Drug | Dasotraline 2 mg |
| DasotralineAlso: SEP-225289Dasotraline 4 mg once daily | Drug | Dasotraline 4 mg |
| Placebo ComparatorPlacebo once daily | Drug | Placebo |
Primary outcome
Change from baseline at Week 6 in ADHD symptoms as measured by ADHD RS IV HV.
Time frame: Baseline, 6 Weeks
25 secondary outcomes
Change from baseline in ADHD symptoms as measured by in ADHD RS IV HV at Weeks 1, 2, 3, 4, and 5.
Time frame: Baseline, Weeks 1,2,3,4,5
Change from baseline in the inattentiveness and hyperactivity subscales of the ADHD RS IV HV at Weeks 1, 2, 3, 4, 5, and 6.
Time frame: Baseline, Weeks 1,2,3,4,5,6
The percentage of responders at Weeks 1, 2, 3, 4, 5, and 6. A responder is defined as a subject with a ≥ 30% improvement in ADHD symptoms compared with baseline as measured by the ADHD RS IV HV.
Time frame: Baseline, Weeks 1,2,3,4,5,6
Change from baseline in CGI-S scale at Weeks 1, 2, 3, 4, 5, and 6.
Time frame: Baseline, Weeks 1,2,3,4,5,6
Change from baseline in Conners 3 P total score and subscale scores (Oppositional, Cognitive problems, Hyperactivity, and ADHD Index) at Weeks 1, 2, 3, 4, 5, and 6.
Time frame: Baseline, Weeks 1,2,3,4,5,6
Change from baseline in Conners 3 T total score at Weeks 3 and 6.
Time frame: Baseline, Weeks 3, 6
Change from baseline in WPREMB R total score and subscores at Weeks 1, 2, 3, 4, 5, and 6.
Time frame: Baseline, Weeks 1,2,3,4,5,6
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations.
Time frame: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (serum chemistry).
Time frame: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (hematology).
Time frame: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (lipid panel).
Time frame: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (thyroid panel).
Time frame: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (sex hormones).
Time frame: Baseline, 6 Weeks
Absolute values and change from baseline in clinical laboratory evaluations (urinalysis).
Time frame: Baseline, 6 Weeks
Absolute values and changes from baseline in 12 lead ECGs.
Time frame: Baseline, 6 Weeks
Absolute values and changes from baseline in vital signs.
Time frame: Baseline, 6 Weeks
Absolute values and changes from baseline in body weights.
Time frame: Baseline, 6 Weeks
Change from baseline in CSHQ total score and 8 subscale scores (bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness) at Weeks 1, 2, 3, 4, 5, and 6.
Time frame: Baseline, Weeks 1,2,3,4,5,6
Change from baseline in Tanner staging at Week 6.
Time frame: 6 Weeks
Frequency of suicidal ideation and suicidal behavior as assessed by the C SSRS.
Time frame: 6 Weeks
Severity of suicidal ideation and suicidal behavior as assessed by the C SSRS.
Time frame: 6 Weeks
Dasotraline plasma concentration for PK at Weeks 2, 4, and 6.
Time frame: Baseline, Weeks 2,4,6
Change from baseline in DHPG concentration at Weeks 2, 4, and 6.
Time frame: Baseline, Weeks 2,4,6
Change from baseline in NE concentration at Weeks 2, 4, and 6.
Time frame: Baseline, Weeks 2,4,6
Change from baseline in WFIRS P total score and 6 domain scores (family, learning and school, life skills, child's self-concept, social activities and risky activities) at Week 3 and 6.
Time frame: Baseline, Weeks 3,6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 41697570Gumenyuk S, Ogirala A, Szabo ST, Koblan K, Hopkins SC, Ufer M. Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System. Clin Drug Investig. 2026 Apr;46(4):455-465. doi: 10.1007/s40261-026-01525-3. Epub 2026 Feb 16.
- Derived from this study: PubMed 30694697Findling RL, Adler LA, Spencer TJ, Goldman R, Hopkins SC, Koblan KS, Kent J, Hsu J, Loebel A. Dasotraline in Children with Attention-Deficit/Hyperactivity Disorder: A Six-Week, Placebo-Controlled, Fixed-Dose Trial. J Child Adolesc Psychopharmacol. 2019 Mar;29(2):80-89. doi: 10.1089/cap.2018.0083. Epub 2019 Jan 29.
Related trials for Attention Deficit Hyperactivity Disorder
Not yet recruiting
Development and Evaluation of a Digital Game Intervention Targeting Children Vulnerable to ADHD
ADHD or ADHD Traits
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingObservational study
Multimodal Biomarkers Predicting Medication-Induced Adverse Effects in Children With ADHD
ADHD
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Not yet recruitingObservational study
Phase 1: Thrive Together
Attention-Deficit/Hyperactivity Disorder (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dasotraline Medical Director, MD study director
Sumitomo Pharma America, Inc.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dasotraline in people with Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 43 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 18 inclusion and 29 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline at Week 6 in ADHD symptoms as measured by ADHD RS IV HV. (time frame: Baseline, 6 Weeks). 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 NCT02428088, which also lists 2 linked publications.
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 18 Mar 2021.