Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT ID: NCT04507204

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2022-01-31

Brief Summary

The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with the active comparator group (Concerta) over time.

Detailed Description

This phase IV study is a prospective, open-label, randomized, pragmatic study to investigate the treatment effectiveness of Adhansia XR at Month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with the active comparator group (OROS MPH or Concerta) over time. Additional outcome assessments for both treatment arms include Health-Related Quality of Life (HRQoL) during the 6-month follow-up period. The burden of illness (BOI) will be investigated by collecting additional measures such as healthcare resource utilization (HCRU), broader treatment patterns, and comorbidities.

Conditions

Attention-Deficit/Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adhansia XR

Adhansia XR capsules taken orally once daily with or without food.

Group Type: EXPERIMENTAL

Adhansia XR

Intervention Type: DRUG

Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)

Concerta

Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.

Group Type: ACTIVE_COMPARATOR

Concerta

Intervention Type: DRUG

An osmotic-controlled oral release delivery system (OROS) of methylphenidate HCl (MPH) extended-release tablets taken once daily (18 mg, 27 mg, 36 mg, and 54 mg)

Interventions

Adhansia XR

Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)

Intervention Type: DRUG

Concerta

An osmotic-controlled oral release delivery system (OROS) of methylphenidate HCl (MPH) extended-release tablets taken once daily (18 mg, 27 mg, 36 mg, and 54 mg)

Intervention Type: DRUG

Other Intervention Names

Methylphenidate hydrochloride (HCl) extended release; Methylphenidate hydrochloride (HCl)

Eligibility Criteria

Inclusion Criteria

• Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) has made the decision to prescribe an extended-release methylphenidate (ER MPH) product to the patient for potential improvement of symptoms throughout and later in the day, independent of this study.
• Patient must be 12 years of age or older.

Exclusion Criteria

• Patient must be willing to take only the assigned study medication per HCP instructions based on FDA label guidance for treatment of their ADHD for the first 2 months of the study (i.e. full titration period). Patients should not be on any other medication, or starting any new non-medication treatment, proven to have effect on ADHD in the first two months of the study.

• Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol.
• Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), or sympathomimetic amines, history of serious adverse reactions to MPH or AMP or be known to be non-responsive to MPH or AMP treatment.
• Patient is currently stable on their ADHD treatment regimen.
• Female patients of child bearing potential who are pregnant, planning on becoming pregnant or breastfeeding.
• Patient with any known conditions that are contraindicated for either Adhansia XR or OROS MPH (or Concerta) use, as documented in the US Full Prescribing Information, including patients with any known serious structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
• Patients with a known sensitivity to the food dye tartrazine (Federal Food, Drug, and Cosmetic Yellow No. 5).
• Suicidal Ideation

• The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered at screening and at Month-2, Month-4, and Month-6, but also depends on the judgment of the HCP.
• Inability or unwillingness of the patient (or parent/guardian if patient is a minor) to complete the study-required electronic questionnaires and provide required information through electronic means.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harmonex, Inc.

Dothan, Alabama, United States

Southern California Research LLC

Beverly Hills, California, United States

CT Clinical Research

Cromwell, Connecticut, United States

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Reliable Clinical Research, LLC

Hialeah, Florida, United States

Eastern Research. Inc.

Hialeah, Florida, United States

Wellness Research Center Inc.

Miami, Florida, United States

AdventHealth Medical Group Pediatrics at Orange City

Orange City, Florida, United States

Pediatric Epilepsy & Neurology Specialists

Tampa, Florida, United States

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, United States

Revive Research Institute

Elgin, Illinois, United States

AMR-Baber Research Inc.

Naperville, Illinois, United States

BTC of New Bedford, LLC

New Bedford, Massachusetts, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Psychiatric Care and Research Center

O'Fallon, Missouri, United States

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, United States

Clinical Research of Southern Nevada, LLC

Las Vegas, Nevada, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Bioscience Research, LLC

Mount Kisco, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Mid-Ohio Behavioral Health

Columbus, Ohio, United States

SFM Clinical Trials

Scotland, Pennsylvania, United States

Rainbow Research

Barnwell, South Carolina, United States

FutureSearch Trials of Dallas, LP

Dallas, Texas, United States

InSite Clinical Research, LLC

DeSoto, Texas, United States

Red Oak Psychiatry Associates, PA

Houston, Texas, United States

Road Runner Research, Ltd.

San Antonio, Texas, United States

Family Psychiatry of the Woodlands

The Woodlands, Texas, United States

Dixie Pediatrics

St. George, Utah, United States

Clinical Research Partners, LLC

Petersburg, Virginia, United States

Eastside Therapeutic Resource Inc dba Core Clinical Research

Everett, Washington, United States

MultiCare Health System - Rockwood Clinic

Spokane, Washington, United States

Countries

United States

References

Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.

Reference Type: DERIVED

PMID: 35201607 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ADA4003

Identifier Type: -

Identifier Source: org_study_id