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

Real-world Evidence of Duration of Adhansia XR for Treatment of ADHD (RE-DAX): An Open-label Pragmatic Study to Assess the Real-world Effectiveness of Adhansia XR in Treatment of Adult and Adolescent Patients With ADHD in the United States

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.

Study Overview

• Status: Terminated
• Conditions: Attention-Deficit/Hyperactivity Disorder
• Intervention / Treatment: Drug: Adhansia XR; Drug: Concerta

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.

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Harmonex, Inc.
  • California
    • Beverly Hills, California, United States, 90210
      • Southern California Research LLC
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • CT Clinical Research
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Hialeah, Florida, United States, 33012
      • Reliable Clinical Research, LLC
    • Hialeah, Florida, United States, 33013
      • Eastern Research. Inc.
    • Miami, Florida, United States, 33135
      • Wellness Research Center Inc.
    • Orange City, Florida, United States, 32763
      • AdventHealth Medical Group Pediatrics at Orange City
    • Tampa, Florida, United States, 33609
      • Pediatric Epilepsy & Neurology Specialists
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Clinical Integrative Research Center of Atlanta
  • Illinois
    • Elgin, Illinois, United States, 60123
      • Revive Research Institute
    • Naperville, Illinois, United States, 60563
      • AMR-Baber Research Inc.
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • BTC of New Bedford, LLC
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Neurobehavioral Medicine Group
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Center for Behavioral Medicine
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates - Midwest Research Group
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Clinical Research of Southern Nevada, LLC
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center For Emotional Fitness
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research, LLC
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Mid-Ohio Behavioral Health
  • Pennsylvania
    • Scotland, Pennsylvania, United States, 17254
      • SFM Clinical Trials
  • South Carolina
    • Barnwell, South Carolina, United States, 29812
      • Rainbow Research
  • Texas
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research, LLC
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates, PA
    • San Antonio, Texas, United States, 78249
      • Road Runner Research, Ltd.
    • The Woodlands, Texas, United States, 77381
      • Family Psychiatry of The Woodlands
  • Utah
    • Saint George, Utah, United States, 84790
      • Dixie Pediatrics
  • Virginia
    • Petersburg, Virginia, United States, 23805
      • Clinical Research Partners, LLC
  • Washington
    • Everett, Washington, United States, 98201
      • Eastside Therapeutic Resource Inc dba Core Clinical Research
    • Spokane, Washington, United States, 99202
      • MultiCare Health System - Rockwood Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
• Patient must be eligible to receive Adhansia XR or osmotic- release oral delivery system methylphenidate ([OROS MPH] or Concerta) according to the US product labels; a patient must be eligible and willing to receive either drug, as randomization will assign them to a specific treatment group. Patient may be treatment-experienced or naïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusion criteria are met.
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adhansia XR; Adhansia XR capsules taken orally once daily with or without food.	Drug: Adhansia XR; Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg); Other Names: Methylphenidate hydrochloride (HCl) extended release
Active Comparator: Concerta; Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.	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); Other Names: Methylphenidate hydrochloride (HCl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR	The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity.	Baseline to Month-2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)	The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates "poor" from "good" sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality.	Baseline and Months -2, -4, and -6
Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority	TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.	Month-2
Assessment of Clinical Global Impression-Severity (CGI-S)	The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.	Baseline, Month-2, Month-4, and Month-6
Assessment of Clinical Global Impression-Improvement (CGI-I)	The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.	Month-2, Month-4, and Month-6
Assessment of Treatment Satisfaction	The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100. A lower score indicates a lower satisfaction with treatment.	Month-1, Month-2, and Month-6
Healthcare Resource Utilization (HCRU)	A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.	Baseline (past 6 months) Months -2, -4, and -6
Adult ADHD Quality of Life Scale - Revised (AAQoL-R)	Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.	Baseline, Months -1, -2, -3, -4, -5 and -6
Work Productivity and Activity Impairment (WPAI) Questionnaire	The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains [absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Baseline, Months -2, -3, -4, -5, and -6

Collaborators and Investigators

• Sponsor: Purdue Pharma LP

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): December 22, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ADHD; Phase IV; Methylphenidate; OROS; Adhansia XR; MPH
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: ADA4003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No