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

NCT04507204 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: ADA4003
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 35

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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

ADHD; Methylphenidate; Adhansia XR; MPH; OROS; Phase IV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority

  Month-2

• Assessment of Clinical Global Impression-Severity (CGI-S)

  Baseline, Month-2, Month-4, and Month-6

• Assessment of Clinical Global Impression-Improvement (CGI-I)

  Month-2, Month-4, and Month-6

• Assessment of Treatment Satisfaction

  Month-1, Month-2, and Month-6

• Healthcare Resource Utilization (HCRU)

  Baseline (past 6 months) Months -2, -4, and -6

Study Arms (2)

Adhansia XR

EXPERIMENTAL

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

Drug: Adhansia XR

Concerta

ACTIVE COMPARATOR

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

Drug: Concerta

Interventions

Adhansia XR DRUG

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

Also known as: Methylphenidate hydrochloride (HCl) extended release

Adhansia XR

Concerta 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)

Also known as: Methylphenidate hydrochloride (HCl)

Concerta

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (35)

Harmonex, Inc.

Dothan, Alabama, 36303, United States

Location

Southern California Research LLC

Beverly Hills, California, 90210, United States

Location

CT Clinical Research

Cromwell, Connecticut, 06416, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Reliable Clinical Research, LLC

Hialeah, Florida, 33012, United States

Location

Eastern Research. Inc.

Hialeah, Florida, 33013, United States

Location

Wellness Research Center Inc.

Miami, Florida, 33135, United States

Location

AdventHealth Medical Group Pediatrics at Orange City

Orange City, Florida, 32763, United States

Location

Pediatric Epilepsy & Neurology Specialists

Tampa, Florida, 33609, United States

Location

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, 30328, United States

Location

Revive Research Institute

Elgin, Illinois, 60123, United States

Location

AMR-Baber Research Inc.

Naperville, Illinois, 60563, United States

Location

BTC of New Bedford, LLC

New Bedford, Massachusetts, 02740, United States

Location

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Clinical Research of Southern Nevada, LLC

Las Vegas, Nevada, 89128, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Mid-Ohio Behavioral Health

Columbus, Ohio, 43205, United States

Location

SFM Clinical Trials

Scotland, Pennsylvania, 17254, United States

Location

Rainbow Research

Barnwell, South Carolina, 29812, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

InSite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

Red Oak Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

Road Runner Research, Ltd.

San Antonio, Texas, 78249, United States

Location

Family Psychiatry of the Woodlands

The Woodlands, Texas, 77381, United States

Location

Dixie Pediatrics

St. George, Utah, 84790, United States

Location

Clinical Research Partners, LLC

Petersburg, Virginia, 23805, United States

Location

Eastside Therapeutic Resource Inc dba Core Clinical Research

Everett, Washington, 98201, United States

Location

MultiCare Health System - Rockwood Clinic

Spokane, Washington, 99202, United States

Location

Related Publications (1)

• 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.

  PMID: 35201607 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jaromir Mikl, PhD MSPH
• Organization: Purdue Pharma L.P.

jaromir.mikl@pharma.com

800-745-7445

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 11, 2020
• Study Start: July 30, 2020
• Primary Completion: December 22, 2021
• Study Completion: January 31, 2022
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)