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

Phase 4

Terminated

Conditions: Attention-Deficit/Hyperactivity Disorder

Interventions: Drug: Adhansia XR
Drug: Concerta

Registration Number: NCT04507204

Lead Sponsor: Purdue Pharma LP

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 267

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adhansia XR	Adhansia XR	Adhansia XR capsules taken orally once daily with or without food.
Concerta	Concerta	Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.

Primary Outcome Measures

Name	Time	Method
Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR	Baseline to Month-2	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.

Secondary Outcome Measures

Name	Time	Method
Healthcare Resource Utilization (HCRU)	Baseline (past 6 months) Months -2, -4, and -6	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.
Work Productivity and Activity Impairment (WPAI) Questionnaire	Baseline, Months -2, -3, -4, -5, and -6	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.
Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority	Month-2	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.
Assessment of Clinical Global Impression-Severity (CGI-S)	Baseline, Month-2, Month-4, and Month-6	The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.
Assessment of Treatment Satisfaction	Month-1, Month-2, and Month-6	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.
Adult ADHD Quality of Life Scale - Revised (AAQoL-R)	Baseline, Months -1, -2, -3, -4, -5 and -6	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.
Assessment of Clinical Global Impression-Improvement (CGI-I)	Month-2, Month-4, and Month-6	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.
Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)	Baseline and Months -2, -4, and -6	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.

Trial Locations

Locations (35): Neurobehavioral Medicine Group
🇺🇸
Bloomfield Hills, Michigan, United States
InSite Clinical Research, LLC
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DeSoto, Texas, United States
Rochester Center for Behavioral Medicine
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Rochester Hills, Michigan, United States
Psychiatric Care and Research Center
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O'Fallon, Missouri, United States
Bioscience Research, LLC
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Mount Kisco, New York, United States
St. Charles Psychiatric Associates - Midwest Research Group
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Saint Charles, Missouri, United States
Center for Emotional Fitness
🇺🇸
Cherry Hill, New Jersey, United States
Dixie Pediatrics
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Saint George, Utah, United States
SFM Clinical Trials
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Scotland, Pennsylvania, United States
Eastside Therapeutic Resource Inc dba Core Clinical Research
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Everett, Washington, United States
Clinical Research Partners, LLC
🇺🇸
Petersburg, Virginia, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Southern California Research LLC
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Beverly Hills, California, United States
Revive Research Institute
🇺🇸
Elgin, Illinois, United States
BTC of New Bedford, LLC
🇺🇸
New Bedford, Massachusetts, United States
AMR-Baber Research Inc.
🇺🇸
Naperville, Illinois, United States
Rainbow Research
🇺🇸
Barnwell, South Carolina, United States
MultiCare Health System - Rockwood Clinic
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Spokane, Washington, United States
AdventHealth Medical Group Pediatrics at Orange City
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Orange City, Florida, United States
Harmonex, Inc.
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Dothan, Alabama, 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
Pediatric Epilepsy & Neurology Specialists
🇺🇸
Tampa, Florida, United States
Clinical Integrative Research Center of Atlanta
🇺🇸
Atlanta, Georgia, United States
Clinical Research of Southern Nevada, LLC
🇺🇸
Las Vegas, Nevada, United States
Richmond Behavioral Associates
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Staten Island, New York, United States
Duke University Medical Center
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Durham, North Carolina, United States
Mid-Ohio Behavioral Health
🇺🇸
Columbus, Ohio, United States
FutureSearch Trials of Dallas, LP
🇺🇸
Dallas, 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