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

NCT ID: NCT02683265

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-25
• Study Completion Date: 2018-03-27

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Aptensio XR

Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg Aptensio XR)

Group Type: EXPERIMENTAL

Aptensio XR

Intervention Type: DRUG

Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg) administered orally, once daily

Placebo comparator

Placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules

Interventions

Aptensio XR

Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg) administered orally, once daily

Intervention Type: DRUG

Placebo

Placebo capsules

Intervention Type: DRUG

Other Intervention Names

methylphenidate, extended release; Dose-matched placebo

Eligibility Criteria

Inclusion Criteria

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

2. 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)

3. ADHD symptoms must have been present for at least 6 months

4. Age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the ADHD-RS-IV Preschool Version

5. Score of < 65 on the Child Global Assessment Scale (CGAS)

6. 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)

7. 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.

8. The subject had a parent or legal guardian who would give written informed consent for the subject to participate in the study

9. Subject and parent or legal guardian must have been able to speak and understand English

10. Subject must live with primary caretaker/rater and have been living with primary caretaker for at least 6 months

11. Subject and parent/guardian must have been willing and able to comply with all requirements of the protocol

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

Exclusion Criteria

1. The subject had a lack of response to a trial of adequate dose and duration of MPH or intolerance to previous methylphenidate (MPH) treatment

2. 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

3. The subject had used monoamine oxidase inhibitors (MAOIs) within 14 days of the screening visit

4. The subject planned to use prohibited drugs or agents at any point between the screening visit and the end of the study

5. Use of anticonvulsants, antidepressants, or antipsychotics in the 30 days prior to screening

6. The subject should not plan to start any additional psychotherapy outside of the trial during the duration of the study

7. The subject had a history of chronic vocal or motor tics or Tourette's syndrome

8. The subject had any clinically significant ECG abnormalities at screening

9. The subject had any major medical conditions that would have interfered with involvement in the study or could have been affected negatively by methylphenidate

10. 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

11. 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

12. Family history (parent or sibling) of structural cardiovascular disease

13. Current or recent (past 12 months) history of drug abuse in someone living in the subject's home

14. 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 required treatment with additional medication or, in the opinion of the PI, would have contraindicated study participation

15. History or presence of suicidal ideation or significant self-injurious behavior

16. The subject showed evidence of current physical, sexual, or emotional abuse

17. Both biological parents of the subject had a history of bipolar disorder

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhodes Pharmaceuticals, L.P.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Childress, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Psychiatry And Behavioral Medicine Inc.

Locations

Center for Psychiatry and Behavioral Medicine Inc.

Las Vegas, Nevada, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7047252/

Related Info

Other Identifiers

RP-BP-EF003

Identifier Type: -

Identifier Source: org_study_id