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

Purdue Pharma

Status and phase

Terminated

Phase 4

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Drug: Concerta

Drug: Adhansia XR

Study type

Interventional

Funder types

Industry

Identifiers

NCT04507204

ADA4003

Details and patient eligibility

About

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.

Full 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.

Enrollment

267 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.