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

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhodes Pharmaceuticals, L.P.
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Male and female subjects ages 48 months to 68 months inclusive at time of consent

• Meets 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 six months

• Age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the ADHD-RS-IV Preschool Version (rated over past six months)

• Score of <65 on the Child Global Assessment Scale

• Must have a score of ≥4 on the Clinical Global Impressions Severity (CGI-S) at Visit 2

• Estimated IQ ≥80 on the Kaufman Brief Intelligence Test, Second Edition (KBIT-2)

• The subject has a parent or legal guardian who will give written informed consent for the subject to participate in the study

• Subject and parent or legal guardian must be 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 or legally authorized representative must be willing and able to comply with all requirements of this protocol

• Systolic and diastolic blood pressure below the 95th percentile for age and gender

Exclusion Criteria:

• The subject has had a lack of response to a trial of adequate dose and duration of MPH or intolerance to previous MPH treatment

• The subject is using any other current psychotropic medication except clonidine, guanfacine, atomoxetine and /or stimulants or has taken an investigational drug in the 30 days prior to screening

• The subject has used monoamine oxidase inhibitors within 14 days of the screening visit

• The subject plans 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 start any additional psychotherapy outside of the trial during the duration of the study

• The subject has a history of chronic vocal or motor tics or Tourette's syndrome

• The subject has any clinically significant ECG abnormalities at screening

• The subject has any major medical conditions that would interfere with involvement in a study or could be affected negatively by methylphenidate

• The subject has 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 put the subject at risk if he/she participates in the trial or could confound 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, depression, severe anxiety disorder, obsessive compulsive disorder or autistic spectrum disorder) in addition to ADHD that requires treatment with additional medication or, in the opinion of the PI, would contraindicate study participation History or presence of suicidal ideation or significant self-injurious behavior

• The subject shows evidence of current physical, sexual, or emotional abuse

• Both biological parents of the subject have a history of bipolar disorder