Clinical trial NCT04507204: Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Methylphenidate
Adhansia XR
MPH
OROS
Phase IV
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 267
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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.

Primary outcomes:
measure: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR
timeFrame: Baseline to Month-2
Secondary outcomes:
measure: Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority
timeFrame: Month-2
measure: Assessment of Clinical Global Impression-Severity (CGI-S)
timeFrame: Baseline, Month-2, Month-4, and Month-6
measure: Assessment of Clinical Global Impression-Improvement (CGI-I)
timeFrame: Month-2, Month-4, and Month-6
measure: Assessment of Treatment Satisfaction
timeFrame: Month-1, Month-2, and Month-6
measure: Healthcare Resource Utilization (HCRU)
timeFrame: Baseline (past 6 months) Months -2, -4, and -6
measure: Adult ADHD Quality of Life Scale - Revised (AAQoL-R)
timeFrame: Baseline, Months -1, -2, -3, -4, -5 and -6
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: Baseline, Months -2, -3, -4, -5, and -6
measure: Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and Months -2, -4, and -6
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex, Inc.
state: Alabama
city: Beverly Hills
country: United States
facility: Southern California Research LLC
state: California
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Eastern Research. Inc.
state: Florida
city: Miami
country: United States
facility: Wellness Research Center Inc.
state: Florida
city: Orange City
country: United States
facility: AdventHealth Medical Group Pediatrics at Orange City
state: Florida
city: Tampa
country: United States
facility: Pediatric Epilepsy & Neurology Specialists
state: Florida
city: Atlanta
country: United States
facility: Clinical Integrative Research Center of Atlanta
state: Georgia
city: Elgin
country: United States
facility: Revive Research Institute
state: Illinois
city: Naperville
country: United States
facility: AMR-Baber Research Inc.
state: Illinois
city: New Bedford
country: United States
facility: BTC of New Bedford, LLC
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group
state: Michigan
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research of Southern Nevada, LLC
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Mid-Ohio Behavioral Health
state: Ohio
city: Scotland
country: United States
facility: SFM Clinical Trials
state: Pennsylvania
city: Barnwell
country: United States
facility: Rainbow Research
state: South Carolina
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of the Woodlands
state: Texas
city: Saint George
country: United States
facility: Dixie Pediatrics
state: Utah
city: Petersburg
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Everett
country: United States
facility: Eastside Therapeutic Resource Inc dba Core Clinical Research
state: Washington
city: Spokane
country: United States
facility: MultiCare Health System - Rockwood Clinic
state: Washington
Study officials:
References:
citation: 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.