A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.

NCT03231800 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: SEP-360-311
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 8

Brief Summary

A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.

Conditions

Attention-Deficit Hyperactivity Disorder (ADHD)

Keywords

Attention-Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose)

  The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.

  Baseline to Day 15

Secondary Outcomes (4)

• Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)

  Baseline to Day 15

• Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)

  Baseline to Day 15

• Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Attempted Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)

  Baseline to Day 15

• Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)

  Baseline to Day 15

Study Arms (2)

Dasotraline

EXPERIMENTAL

Dasotraline capsule 2mg/day

Drug: dasotraline

Placebo

PLACEBO COMPARATOR

Placebo capsule

Drug: Placebo

Interventions

dasotraline DRUG

dasotraline 2mg capsule once daily

Also known as: SEP-225289

Dasotraline

Placebo DRUG

Placebo capsule 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 is 6 - 12 years old, inclusive at screening and randomization.
• Subject weighs ≤ 30 kg at the time of screening.
• At least one of the subject's parents/legal guardians must give written informed consent, including privacy authorization, prior to study participation. The subject will provide informed assent prior to study participation.
• 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 and confirmed using the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) at screening.
• Subject is currently either untreated for ADHD or receiving a treatment regimen of a stimulant medication prescribed as monotherapy (i.e., methylphenidate, mixed amphetamine salts, lisdexamphetamine, or dextroamphetamine) within the approved labeled dose range for ADHD..
• In the opinion of the investigator, the subject is not treatment refractory.
• Any subject not receiving ADHD medication at screening must display clinically significant ADHD symptoms, as measured by an ADHD-RS-IV score ≥ 26 at screening and Day -7.
• For any subject receiving monotherapy stimulant treatment for ADHD, that treatment must be well tolerated and clinically effective based on clinical assessment and informant interview, as well as, review of available medical records. Note: The ADHD Rating Scale Version IV - Home Version (modified for investigator administration) (ADHD RS IV HV) will be administered at Screening by the investigator to inform clinical evaluation.
• Subject is male or a non-pregnant, non-lactating female.
• Subject, if female, must not be pregnant or breastfeeding, and if ≥ 8 years of age must have a negative serum pregnancy test at screening.
• Female subjects of childbearing potential and male subjects with female partners of childbearing potential must practice true abstinence (consistent with lifestyle) and must agree to remain abstinent or agree to use an effective and medically acceptable form of birth control, from the time of informed consent/assent to at least 14 days after the last dose of the 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, 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 can be included only if the investigator determines the deviations to be not clinically relevant.
• Subject is within the 3rd to 97th percentile for gender specific weight-for-age from the Centers for Disease Control and Prevention (CDC) growth charts
• Subject must report a history of being able to swallow capsules.
• Subject and subject's parent/legal guardian must be able to fully comprehend the informed consent/assent forms, understand and be willing and able to comply with all study procedures and visit schedule, and be able to communicate satisfactorily with the investigator and study coordinator.

You may not qualify if:

• Subject or parent/legal guardian has commitments during the study that would interfere with attending study visits.
• Subject is currently being treated for ADHD with a non-stimulant product, or has been treated with a non-stimulant product in the 4 weeks prior to the start of screening.
• Subject has failed 2 adequate courses (dose and duration) of stimulant or non-stimulant treatment for ADHD.
• Subject is considered treatment refractory, as judged by the investigator.
• 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 diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, 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 a first-degree relative (biological parent or sibling) with a history of schizophrenia, schizoaffective disorder, bipolar I disorder, or bipolar II disorder.
• Subject has generalized anxiety disorder or panic disorder that has been the primary focus of treatment at any time during the 12 months prior to screening or that has required pharmacotherapy any time during the 6 months prior to screening.
• 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)
• Subjects with a history of persistent neurological symptoms attributable to serious head injury.
• Subjects taking anticonvulsants for seizure control currently or within the past 2 years are not eligible for study participation.
• Subject has uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone (TSH) ≤ 0.8 x the lower limit of normal (LLN) or ≥ 1.25 x the upper limit of normal (ULN) 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 or clinically significant suicidal ideation, in the opinion of the investigator.
• Subject has a history of severe allergies to more than 1 class of medication 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (8)

Avida Inc

Newport Beach, California, 92660, United States

Location

Meridien Research

Bradenton, Florida, 34201, United States

Location

Meridien Research

Maitland, Florida, 32751, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33134, United States

Location

South Shore Psychiatric Services PC

Hingham, Massachusetts, 02043, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc

Las Vegas, Nevada, 89128, United States

Location

Bayou City Research, Ltd

Houston, Texas, 77007, United States

Location

Ericksen Reasearch and Development

Clinton, Utah, 84015, United States

Location

Related Publications (1)

• Wigal S, Tsai J, Bates JA, Sarma K, Tortorich D, Zhu H, Goldman R. A Randomized, Placebo-Controlled Laboratory Classroom Study of the Efficacy and Safety of Dasotraline in Children With ADHD. J Atten Disord. 2022 Aug;26(10):1357-1368. doi: 10.1177/10870547211073477. Epub 2022 Jan 20.

  PMID: 35048745 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

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

ClinicalTrialDisclosure@sunovion.com

1-866-503-6351

Study Officials

• CNS Mecdical Director

  Sunovion Pharmacetuicals Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in children with ADHD in a laboratory classroom setting

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 27, 2017
• Study Start: July 31, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: July 8, 2020
• Results First Posted: June 24, 2020

Record last verified: 2020-06

Locations

US (8)