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

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adhansia XR
Concerta
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring ADHD, Methylphenidate, Adhansia XR, MPH, OROS, Phase IV

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Harmonex, Inc.
  • Southern California Research LLC
  • CT Clinical Research
  • Gulfcoast Clinical Research Center
  • Reliable Clinical Research, LLC
  • Eastern Research. Inc.
  • Wellness Research Center Inc.
  • AdventHealth Medical Group Pediatrics at Orange City
  • Pediatric Epilepsy & Neurology Specialists
  • Clinical Integrative Research Center of Atlanta
  • Revive Research Institute
  • AMR-Baber Research Inc.
  • BTC of New Bedford, LLC
  • Neurobehavioral Medicine Group
  • Rochester Center for Behavioral Medicine
  • Psychiatric Care and Research Center
  • St. Charles Psychiatric Associates - Midwest Research Group
  • Clinical Research of Southern Nevada, LLC
  • Center for Emotional Fitness
  • Bioscience Research, LLC
  • Icahn School of Medicine at Mount Sinai
  • Richmond Behavioral Associates
  • Duke University Medical Center
  • Mid-Ohio Behavioral Health
  • SFM Clinical Trials
  • Rainbow Research
  • FutureSearch Trials of Dallas, LP
  • InSite Clinical Research, LLC
  • Red Oak Psychiatry Associates, PA
  • Road Runner Research, Ltd.
  • Family Psychiatry of the Woodlands
  • Dixie Pediatrics
  • Clinical Research Partners, LLC
  • Eastside Therapeutic Resource Inc dba Core Clinical Research
  • MultiCare Health System - Rockwood Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adhansia XR

Concerta

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority
TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.
Assessment of Clinical Global Impression-Severity (CGI-S)
The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.
Assessment of Clinical Global Impression-Improvement (CGI-I)
The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.
Assessment of Treatment Satisfaction
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 and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100. A lower score indicates a lower satisfaction with treatment.
Healthcare Resource Utilization (HCRU)
A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.
Adult ADHD Quality of Life Scale - Revised (AAQoL-R)
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 quality of life.
Work Productivity and Activity Impairment (WPAI) Questionnaire
The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains [absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
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.

Full Information

First Posted
July 24, 2020
Last Updated
July 7, 2023
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT04507204
Brief Title
Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Acronym
RE-DAX
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
(due to administrative reasons not related to efficacy or safety.)
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma LP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder
Keywords
ADHD, Methylphenidate, Adhansia XR, MPH, OROS, Phase IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adhansia XR
Arm Type
Experimental
Arm Description
Adhansia XR capsules taken orally once daily with or without food.
Arm Title
Concerta
Arm Type
Active Comparator
Arm Description
Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.
Intervention Type
Drug
Intervention Name(s)
Adhansia XR
Other Intervention Name(s)
Methylphenidate hydrochloride (HCl) extended release
Intervention Description
Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)
Intervention Type
Drug
Intervention Name(s)
Concerta
Other Intervention Name(s)
Methylphenidate hydrochloride (HCl)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR
Description
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.
Time Frame
Baseline to Month-2
Secondary Outcome Measure Information:
Title
Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority
Description
TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.
Time Frame
Month-2
Title
Assessment of Clinical Global Impression-Severity (CGI-S)
Description
The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.
Time Frame
Baseline, Month-2, Month-4, and Month-6
Title
Assessment of Clinical Global Impression-Improvement (CGI-I)
Description
The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.
Time Frame
Month-2, Month-4, and Month-6
Title
Assessment of Treatment Satisfaction
Description
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 and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100. A lower score indicates a lower satisfaction with treatment.
Time Frame
Month-1, Month-2, and Month-6
Title
Healthcare Resource Utilization (HCRU)
Description
A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.
Time Frame
Baseline (past 6 months) Months -2, -4, and -6
Title
Adult ADHD Quality of Life Scale - Revised (AAQoL-R)
Description
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 quality of life.
Time Frame
Baseline, Months -1, -2, -3, -4, -5 and -6
Title
Work Productivity and Activity Impairment (WPAI) Questionnaire
Description
The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains [absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time Frame
Baseline, Months -2, -3, -4, -5, and -6
Title
Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline and Months -2, -4, and -6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Harmonex, Inc.
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Southern California Research LLC
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
CT Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Reliable Clinical Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Eastern Research. Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Wellness Research Center Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
AdventHealth Medical Group Pediatrics at Orange City
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Pediatric Epilepsy & Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Clinical Integrative Research Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Revive Research Institute
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Facility Name
AMR-Baber Research Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
BTC of New Bedford, LLC
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Neurobehavioral Medicine Group
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Rochester Center for Behavioral Medicine
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Psychiatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
St. Charles Psychiatric Associates - Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Clinical Research of Southern Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Bioscience Research, LLC
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Mid-Ohio Behavioral Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
SFM Clinical Trials
City
Scotland
State/Province
Pennsylvania
ZIP/Postal Code
17254
Country
United States
Facility Name
Rainbow Research
City
Barnwell
State/Province
South Carolina
ZIP/Postal Code
29812
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
InSite Clinical Research, LLC
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Red Oak Psychiatry Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Road Runner Research, Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Family Psychiatry of the Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Dixie Pediatrics
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Petersburg
State/Province
Virginia
ZIP/Postal Code
23805
Country
United States
Facility Name
Eastside Therapeutic Resource Inc dba Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
MultiCare Health System - Rockwood Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35201607
Citation
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.
Results Reference
derived

Learn more about this trial

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

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