Dasotraline Pediatric ADHD Study

NCT02428088 | Completed Phase 2 DMC

• 1 other identifier: SEP360-202
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 43

Brief Summary

This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline at Week 6 in ADHD symptoms as measured by ADHD RS IV HV.

  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.

  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.

  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.

  Baseline, Weeks 1,2,3,4,5,6

• Change from baseline in CGI-S scale at Weeks 1, 2, 3, 4, 5, and 6.

  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.

  Baseline, Weeks 1,2,3,4,5,6

Study Arms (3)

Dasotraline 2 mg

EXPERIMENTAL

Dasotraline 2 mg

Drug: Dasotraline

Dasotraline 4 mg

EXPERIMENTAL

Dasotraline 4 mg

Drug: Dasotraline

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Comparator

Interventions

Dasotraline DRUG

Dasotraline 2 mg once daily

Also known as: SEP-225289

Dasotraline 2 mg

Placebo Comparator DRUG

Placebo once daily

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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);
• 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;
• 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.

You may not qualify if:

• Subject or parent/legal guardian has commitments during the study that would interfere with attending study visits.
• 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.
• Subject has failed 2 adequate courses of stimulant or non-stimulant treatment for ADHD, as judged by the investigator.
• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (43)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

Synergy Research

National City, California, 91950, United States

Location

California Clinical Trials

Paramount, California, 90723, United States

Location

PCSD-Feighner Research

San Diego, California, 92108, United States

Location

Elite Clinical Trials, Inc.

Wildomar, California, 92595, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Gulfcoast Clinical Research

Fort Myers, Florida, 33912, United States

Location

Sarkis Clinical Trials - Parent

Gainesville, Florida, 32607, United States

Location

Palm Springs Research Institute

Hialeah, Florida, 33012, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32806, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Capstone Clinical Research, Inc.

Libertyville, Illinois, 60048, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

Goldpoint Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Pedia Research,LLC

Newburgh, Indiana, 47630, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Pedia Research,LLC

Owensboro, Kentucky, 42301, United States

Location

Hugo W. Moser Research Institute at Kennedy Krieger

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Neurobehaviorial Medicine Group, PLLC

Bloomfield Hills, Michigan, 48302, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Pharmaceutical Research Associates, Inc.

Marlton, New Jersey, 08053, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Duke University Medical Center - Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

BioBehavioral Research of Austin P.C.

Austin, Texas, 78759, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75228, United States

Location

Bayou City Research Corporation

Houston, Texas, 77007, 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

Road Runner Research

San Antonio, Texas, 78258, United States

Location

Family Psychiatry of The Woodlands, P.A.

The Woodlands, Texas, 77381, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Related Publications (1)

• Findling 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.

  PMID: 30694697 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine; SEP 225289

Condition Hierarchy (Ancestors)

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

Study Officials

• Dasotraline Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 28, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

US (43)