Phase 4 Completed N=119 Randomized Quadruple-blind Other

A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD

Attention Deficit Disorder With Hyperactivity

Source: ClinicalTrials.gov NCT02683265 ↗

Enrolled (actual)

119

Serious AEs

0.5%

Results posted

Feb 2023

Primary outcomePrimary: Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind. — 6.3; 17.3 score on a scale

◆ 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 This can indicate results are unpublished — a known publication-bias signal.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

This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD. Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD (combined, inattentive or hyperactive/impulsive) will be enrolled. There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include washout if applicable, an enrollment & parent training phase lasting 2-4 weeks, an eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a 6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR® responders, and a two-week follow-up call after study completion or early discontinuation to assess for ongoing adverse events and concomitant medications. Up to 150 subjects will be enrolled in this trial to allow for subjects who improve significantly during the behavior training phase and drop-outs. Once 74 subjects have completed the double-blind phase, no additional subjects will be enrolled in the trial. Subjects who are already enrolled at that time will be allowed to complete the trial. The primary objective of this study is to establish that an optimal dose of Aptensio XR® will result in a significant reduction in ADHD symptoms compared with placebo in children ages 4 to under 6 years.

Outcome Measures

Outcome	Result	p-value
PRIMARY Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind.	6.3; 17.3	—
SECONDARY Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Hyperactivity-Impulsivity Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.	3.36; 9.37	—
SECONDARY Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Inattention Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.	2.9; 7.9	—
SECONDARY Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.	7; 13; 15; 14; 8; 11	—
SECONDARY Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).	6; 5; 8; 6; 3; 4	—
SECONDARY Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind	1.92; 7.73; 1.00; 3.67; 3.79; 3.83	—

Eligibility Criteria

Inclusion Criteria

Male and female subjects ages 48 months to 68 months inclusive at time of consent
Met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for ADHD, combined, hyperactive/impulsive or inattentive presentation made during a clinical interview by an experienced clinician and confirmed with Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)
ADHD symptoms must have been present for at least 6 months
Age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the ADHD-RS-IV Preschool Version
Score of < 65 on the Child Global Assessment Scale (CGAS)
Must have had a CGI-S score of ≥ 4 at Visit 2 (subjects who were granted a waiver to bypass parental training, and did not have a Visit 2, were still qualified to continue in the study based on their CGI-S score at screening)
Estimated intelligence quotient (IQ) ≥ 80 on the Kaufman Brief Intelligence Test, 2nd edition (KBIT-2). If results from the KBIT-2 were deemed invalid because of significant ADHD symptomatology, the PI could submit additional documentation to support average cognitive functioning. This documentation could include progress reports from preschool or other previous testing. These exceptions were evaluated by the Medical Monitor and Study PIs on a case-by-case basis for inclusion.
The subject had a parent or legal guardian who would give written informed consent for the subject to participate in the study
Subject and parent or legal guardian must have been able to speak and understand English
Subject must live with primary caretaker/rater and have been living with primary caretaker for at least 6 months
Subject and parent/guardian must have been willing and able to comply with all requirements of the protocol
Systolic and diastolic blood pressure below the 95th percentile for age and gender

Exclusion Criteria

The subject had a lack of response to a trial of adequate dose and duration of MPH or intolerance to previous methylphenidate (MPH) treatment
The subject was using any other current psychotropic medication except clonidine, guanfacine, atomoxetine and/or stimulants or had taken an investigational drug in the 30 days prior to screening
The subject had used monoamine oxidase inhibitors (MAOIs) within 14 days of the screening visit
The subject planned to use prohibited drugs or agents at any point between the screening visit and the end of the study
Use of anticonvulsants, antidepressants, or antipsychotics in the 30 days prior to screening
The subject should not plan to start any additional psychotherapy outside of the trial during the duration of the study
The subject had a history of chronic vocal or motor tics or Tourette's syndrome
The subject had any clinically significant ECG abnormalities at screening
The subject had any major medical conditions that would have interfered with involvement in the study or could have been affected negatively by methylphenidate
The subject had chronic medical illnesses including a seizure disorder (excluding a history of febrile seizures), severe hypertension, untreated thyroid disease, known structural cardiac abnormalities, serious arrhythmias, cardiomyopathy, glaucoma, or a family history of sudden death
History (in the past 12 months) or presence of clinically-significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease that in the opinion of the investigator could have put the subject at risk if he/she participated in the trial or which could have confounded study results
Family history (parent or sibling) of structural cardiovascular disease
Current or recent (past 12 months) history of drug abuse in someone living in the subject's home
Current symptoms or history of major psychiatric illness (for example schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder, depre

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02683265). 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.