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

• Sponsor: Purdue Pharma LP (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04507204
• Collaborator: (none)
• Enrollment: 416
• Locations: 35
• Arms: 2
• Actual Duration (Months): 18.1
• Patients Per Site: 11.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention-Deficit/Hyperactivity Disorder	Drug: Adhansia XR; Drug: Concerta	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 416 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Real-world Evidence of Duration of Adhansia XR for Treatment of ADHD (RE-DAX): An Open-label Pragmatic Study to Assess the Real-world Effectiveness of Adhansia XR in Treatment of Adult and Adolescent Patients With ADHD in the United States
• Actual Study Start Date: Jul 30, 2020
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adhansia XR Adhansia XR capsules taken orally once daily with or without food.	Drug: Adhansia XR; Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg); Other Names: Methylphenidate hydrochloride (HCl) extended release
Active Comparator: Concerta Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.	Drug: Concerta; 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); Other Names: Methylphenidate hydrochloride (HCl)

Outcome Measures

Primary Outcome Measures

1. Change in ADHD-Rating Scale 5 Total Score from Baseline to Month 2 [Baseline to Month-2]

Secondary Outcome Measures

1. Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups [Month-2]

   TASS to be completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit.

2. 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).

3. 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.

4. 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.

5. Healthcare Resource Utilization (HCRU) [Months -1, -2, -3, -4, -5, and -6]

   A comparison of the frequency of health care encounters between the 2 treatment groups.

6. 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 QOL.

7. Work Productivity and Activity Impairment (WPAI) Questionnaire [Baseline, Months -2, -3, -4, -5, and -6]

   The WPAI questionnaire measures work time missed and work and activity impairment because of a specified health problem during the past 7 days for adult patients. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

8. Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale [Baseline, Months -2, -3, -4, -5, and -6]

   Used to assess health-related quality of life of adolescent patients. The DPREMB-R is a parent/caregiver completed 11-item questionnaire; it measures the difficulty level of 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33, where higher scores indicate greater difficulty in evening and morning behavior.

9. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Reliable Clinical Research, LLC	Hialeah	Florida	United States	33012
6	Eastern Research. Inc.	Hialeah	Florida	United States	33013
7	Wellness Research Center Inc.	Miami	Florida	United States	33135
8	AdventHealth Medical Group Pediatrics at Orange City	Orange City	Florida	United States	32763
9	Pediatric Epilepsy & Neurology Specialists	Tampa	Florida	United States	33609
10	Clinical Integrative Research Center of Atlanta	Atlanta	Georgia	United States	30328
11	Revive Research Institute	Elgin	Illinois	United States	60123
12	AMR-Baber Research Inc.	Naperville	Illinois	United States	60563
13	BTC of New Bedford, LLC	New Bedford	Massachusetts	United States	02740
14	Neurobehavioral Medicine Group	Bloomfield Hills	Michigan	United States	48302
15	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan	United States	48307
16	Psychiatric Care and Research Center	O'Fallon	Missouri	United States	63368
17	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri	United States	63304
18	Clinical Research of Southern Nevada, LLC	Las Vegas	Nevada	United States	89128
19	Center for Emotional Fitness	Cherry Hill	New Jersey	United States	08002
20	Bioscience Research, LLC	Mount Kisco	New York	United States	10549
21	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
22	Richmond Behavioral Associates	Staten Island	New York	United States	10312
23	Duke University Medical Center	Durham	North Carolina	United States	27705
24	Mid-Ohio Behavioral Health	Columbus	Ohio	United States	43205
25	SFM Clinical Trials	Scotland	Pennsylvania	United States	17254
26	Rainbow Research	Barnwell	South Carolina	United States	29812
27	FutureSearch Trials of Dallas, LP	Dallas	Texas	United States	75231
28	InSite Clinical Research, LLC	DeSoto	Texas	United States	75115
29	Red Oak Psychiatry Associates, PA	Houston	Texas	United States	77090
30	Road Runner Research, Ltd.	San Antonio	Texas	United States	78249
31	Family Psychiatry of the Woodlands	The Woodlands	Texas	United States	77381
32	Dixie Pediatrics	Saint George	Utah	United States	84790
33	Clinical Research Partners, LLC	Petersburg	Virginia	United States	23805
34	Eastside Therapeutic Resource Inc dba Core Clinical Research	Everett	Washington	United States	98201
35	MultiCare Health System - Rockwood Clinic	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Purdue Pharma LP

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Purdue Pharma LP
• ClinicalTrials.gov Identifier: NCT04507204
• Other Study ID Numbers: ADA4003
• First Posted: Aug 11, 2020
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Purdue Pharma LP: ADHD; Methylphenidate; Adhansia XR; MPH; OROS; Phase IV
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Methylphenidate

Study Results

No Results Posted as of Feb 18, 2022