Status:
TERMINATED
Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Purdue Pharma LP
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
12+ years
Phase:
PHASE4
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 compa...
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 X...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT04507204
Start Date
July 30 2020
End Date
January 31 2022
Last Update
July 27 2023
Active Locations (35)
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1
Harmonex, Inc.
Dothan, Alabama, United States, 36303
2
Southern California Research LLC
Beverly Hills, California, United States, 90210
3
CT Clinical Research
Cromwell, Connecticut, United States, 06416
4
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912