Phase 3
Completed N=132
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.
Source: ClinicalTrials.gov NCT02734693 ↗Enrolled (actual)
132
Serious AEs
0.8%
Results posted
Mar 2020
Primary outcomePrimary: 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) — 1.99; -3.19 Units on a scale — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
1.99; -3.19 | <0.001 sig |
| SECONDARY 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) |
0.79; -0.67 | — |
| SECONDARY 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) |
0.16; -1.44 | — |
| SECONDARY Change From Baseline at Day 15 in Permanent Product Measure of Performance (PERMP)-Attempted and Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose) |
-1.07; 22.60; -1.96; 22.09 | 0.002 sig |
Eligibility Criteria
Inclusion Criteria
- 1. Subject is 6 - 12 years old, inclusive at screening and randomization. 2. 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 on a treatment regimen of a methylphenidate formulation within the approved labeled dose range for ADHD for at least 6 weeks prior to Day -7 with the same dose level for at least 1 week immediately prior to Day -7. Note: if any doses of methylphenidate were missed during the week prior to Day-7, the subject's eligibility will be discussed with the Medical Monitor.
- In the opinion of the investigator, methylphenidate 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. 7. 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 body mass index (BMI)-for-age from the World Health Organization (WHO) growth charts and weighs at least 21 kg.
- Subject must report a history of being able to swallow capsules. 12. 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.
Exclusion Criteria
- 1. Subject or parent/legal guardian has commitments during the study that would interfere with attending study visits.
- Subject, on Day 1, has not demonstrated evidence of worsening of ADHD symptoms as measured by ADHD-RS-IV HV total score ≥ 26 and at least a 30% worsening in ADHD-RS-IV HV total score since the last assessment and following a minimum 72-hour washout from prior methylphenidate treatment.
- Subject is currently being treated for ADHD with an amphetamine-based product, or has been treated with an amphetamine-based product in the 6 weeks prior to the start of screening.
- Subject is currently being treated for ADHD with a non-methylphenidate product, or has been treated with a non-methylphenidate product in the 6 weeks prior to the
Data sourced from ClinicalTrials.gov (NCT02734693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.