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

Stopped early · Phase 4

Conditions studied: Attention-Deficit/Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT04507204

Run by

Purdue Pharma LP

People needed

267

Starts

2020-07-30

Expected to finish

2022-01-31

Last updated by the study team

2023-07-27

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

You may not qualify if…

• 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.

Where it is running

• Harmonex, Inc. — Dothan, Alabama, United States
• Southern California Research LLC — Beverly Hills, California, 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
• AdventHealth Medical Group Pediatrics at Orange City — Orange City, Florida, United States
• Pediatric Epilepsy & Neurology Specialists — Tampa, Florida, United States
• Clinical Integrative Research Center of Atlanta — Atlanta, Georgia, United States
• Revive Research Institute — Elgin, Illinois, United States
• AMR-Baber Research Inc. — Naperville, Illinois, United States
• BTC of New Bedford, LLC — New Bedford, Massachusetts, United States
• Neurobehavioral Medicine Group — Bloomfield Hills, Michigan, United States
• Rochester Center for Behavioral Medicine — Rochester Hills, Michigan, United States
• Psychiatric Care and Research Center — O'Fallon, Missouri, United States
• St. Charles Psychiatric Associates - Midwest Research Group — Saint Charles, Missouri, United States
• Clinical Research of Southern Nevada, LLC — Las Vegas, Nevada, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Bioscience Research, LLC — Mount Kisco, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Mid-Ohio Behavioral Health — Columbus, Ohio, United States
• SFM Clinical Trials — Scotland, Pennsylvania, United States

Full record on ClinicalTrials.gov

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