Attention-Deficit/Hyperactivity DisorderPhase 4RE-DAXNCT04507204
Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 4 study testing Adhansia XR and Concerta in people with Attention-Deficit/Hyperactivity Disorder, run by Purdue Pharma LP at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Adhansia XR and Concerta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 35 sitesUnited States
- Study dates
- 30 Jul 2020to 31 Jan 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, 30328
Rainbow Research
Barnwell, South Carolina, 29812
Southern California Research LLC
Beverly Hills, California, 90210
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Mid-Ohio Behavioral Health
Columbus, Ohio, 43205
CT Clinical Research
Cromwell, Connecticut, 06416
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
InSite Clinical Research, LLC
DeSoto, Texas, 75115
Harmonex, Inc.
Dothan, Alabama, 36303
Duke University Medical Center
Durham, North Carolina, 27705
Revive Research Institute
Elgin, Illinois, 60123
Eastside Therapeutic Resource Inc dba Core Clinical Research
Everett, Washington, 98201
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Reliable Clinical Research, LLC
Hialeah, Florida, 33012
Eastern Research. Inc.
Hialeah, Florida, 33013
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada, 89128
Wellness Research Center Inc.
Miami, Florida, 33135
Bioscience Research, LLC
Mount Kisco, New York, 10549
AMR-Baber Research Inc.
Naperville, Illinois, 60563
BTC of New Bedford, LLC
New Bedford, Massachusetts, 02740
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
AdventHealth Medical Group Pediatrics at Orange City
Orange City, Florida, 32763
Clinical Research Partners, LLC
Petersburg, Virginia, 23805
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Road Runner Research, Ltd.
San Antonio, Texas, 78249
SFM Clinical Trials
Scotland, Pennsylvania, 17254
MultiCare Health System - Rockwood Clinic
Spokane, Washington, 99202
Dixie Pediatrics
St. George, Utah, 84790
Richmond Behavioral Associates
Staten Island, New York, 10312
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, 33609
Family Psychiatry of the Woodlands
The Woodlands, Texas, 77381
About this study
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
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.
Read the 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.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Adhansia XR, Concerta
- Keywords
- ADHD, Methylphenidate, Adhansia XR, MPH, OROS, Phase IV
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhansia XRDrug
Also called Methylphenidate hydrochloride (HCl) extended release
Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)
ConcertaDrug
Also called Methylphenidate hydrochloride (HCl)
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)
| Study group | Role | What they receive |
|---|---|---|
| Adhansia XR | Experimental | Adhansia XR capsules taken orally once daily with or without food. Receives: Drug: Adhansia XR |
| Concerta | Active comparator | Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food. Receives: Drug: Concerta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Month-2
Secondary outcomes (8)
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.
Measured: Month-2
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.
Measured: Baseline, Month-2, Month-4, and Month-6
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.
Measured: Month-2, Month-4, and Month-6
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.
Measured: Month-1, Month-2, and Month-6
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.
Measured: Baseline (past 6 months) Months -2, -4, and -6
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.
Measured: Baseline, Months -1, -2, -3, -4, -5 and -6
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.
Measured: Baseline, Months -2, -3, -4, -5, and -6
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.
Measured: Baseline and Months -2, -4, and -6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start30 Jul 2020
- Primary completion22 Dec 2021
- Study completion31 Jan 2022
Why it stopped: (due to administrative reasons not related to efficacy or safety.)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507204
- Sponsor's protocol ID
- ADA4003
- Acronym
- RE-DAX
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2020
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35201607
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04507204
- Acronym / sponsor ID
- RE-DAX / ADA4003
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD, Methylphenidate, Adhansia XR, MPH, OROS, Phase IV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: (due to administrative reasons not related to efficacy or safety.)
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhansia XR | Experimental | Drug: Adhansia XRAdhansia XR capsules taken orally once daily with or without food. |
| Concerta | Active comparator | Drug: ConcertaConcerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhansia XRAlso: Methylphenidate hydrochloride (HCl) extended releaseMethylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg) | Drug | Adhansia XR |
| ConcertaAlso: Methylphenidate hydrochloride (HCl)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) | Drug | Concerta |
Primary outcome
Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR
Time frame: Baseline to Month-2
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.
8 secondary outcomes
Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority
Time frame: Month-2
Assessment of Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline, Month-2, Month-4, and Month-6
Assessment of Clinical Global Impression-Improvement (CGI-I)
Time frame: Month-2, Month-4, and Month-6
Assessment of Treatment Satisfaction
Time frame: Month-1, Month-2, and Month-6
Healthcare Resource Utilization (HCRU)
Time frame: Baseline (past 6 months) Months -2, -4, and -6
Adult ADHD Quality of Life Scale - Revised (AAQoL-R)
Time frame: Baseline, Months -1, -2, -3, -4, -5 and -6
Work Productivity and Activity Impairment (WPAI) Questionnaire
Time frame: Baseline, Months -2, -3, -4, -5, and -6
Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and Months -2, -4, and -6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35201607Boesen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adhansia XR and Concerta in people with Attention-Deficit/Hyperactivity Disorder, run by Purdue Pharma LP at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (time frame: Baseline to Month-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.