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

Last updated: July 7, 2023
Sponsor: Purdue Pharma LP
Overall Status: Terminated

Phase

4

Condition

Williams Syndrome

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

Concerta

Adhansia XR

Clinical Study ID

NCT04507204
ADA4003
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and StatisticalManual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) hasmade the decision to prescribe an extended-release methylphenidate (ER MPH) product tothe 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 deliverysystem methylphenidate ([OROS MPH] or Concerta) according to the US product labels; apatient must be eligible and willing to receive either drug, as randomization willassign them to a specific treatment group. Patient may be treatment-experienced ornaïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusioncriteria are met.
  • Patient must be willing to take only the assigned study medication per HCPinstructions based on FDA label guidance for treatment of their ADHD for the first 2months of the study (i.e. full titration period). Patients should not be on any othermedication, or starting any new non-medication treatment, proven to have effect onADHD in the first two months of the study.

Exclusion

Exclusion Criteria:

  • Concurrent participation in an investigational study in which patient assessmentand/or treatment may be dictated by a protocol.
  • Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), orsympathomimetic amines, history of serious adverse reactions to MPH or AMP or be knownto 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 becomingpregnant or breastfeeding.
  • Patient with any known conditions that are contraindicated for either Adhansia XR orOROS 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, andCosmetic Yellow No. 5).
  • Suicidal Ideation
  • The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered atscreening and at Month-2, Month-4, and Month-6, but also depends on the judgmentof 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 requiredinformation through electronic means.

Study Design

Total Participants: 267
Treatment Group(s): 2
Primary Treatment: Concerta
Phase: 4
Study Start date:
July 30, 2020
Estimated Completion Date:
January 31, 2022

Study 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.

Connect with a study center

  • Harmonex, Inc.

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Southern California Research LLC

    Beverly Hills, California 90210
    United States

    Site Not Available

  • CT Clinical Research

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Eastern Research. Inc.

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Reliable Clinical Research, LLC

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Wellness Research Center Inc.

    Miami, Florida 33135
    United States

    Site Not Available

  • AdventHealth Medical Group Pediatrics at Orange City

    Orange City, Florida 32763
    United States

    Site Not Available

  • Pediatric Epilepsy & Neurology Specialists

    Tampa, Florida 33609
    United States

    Site Not Available

  • Clinical Integrative Research Center of Atlanta

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Revive Research Institute

    Elgin, Illinois 60123
    United States

    Site Not Available

  • AMR-Baber Research Inc.

    Naperville, Illinois 60563
    United States

    Site Not Available

  • BTC of New Bedford, LLC

    New Bedford, Massachusetts 02740
    United States

    Site Not Available

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Psychiatric Care and Research Center

    O'Fallon, Missouri 63368
    United States

    Site Not Available

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Clinical Research of Southern Nevada, LLC

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Center for Emotional Fitness

    Cherry Hill, New Jersey 08002
    United States

    Site Not Available

  • Bioscience Research, LLC

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Mid-Ohio Behavioral Health

    Columbus, Ohio 43205
    United States

    Site Not Available

  • SFM Clinical Trials

    Scotland, Pennsylvania 17254
    United States

    Site Not Available

  • Rainbow Research

    Barnwell, South Carolina 29812
    United States

    Site Not Available

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas 75231
    United States

    Site Not Available

  • InSite Clinical Research, LLC

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Red Oak Psychiatry Associates, PA

    Houston, Texas 77090
    United States

    Site Not Available

  • Road Runner Research, Ltd.

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Family Psychiatry of the Woodlands

    The Woodlands, Texas 77381
    United States

    Site Not Available

  • Dixie Pediatrics

    Saint George, Utah 84790
    United States

    Site Not Available

  • Clinical Research Partners, LLC

    Petersburg, Virginia 23805
    United States

    Site Not Available

  • Eastside Therapeutic Resource Inc dba Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

  • MultiCare Health System - Rockwood Clinic

    Spokane, Washington 99202
    United States

    Site Not Available

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