A Phase 4 interventional study of Adhansia XR and Concerta in Attention-Deficit/Hyperactivity Disorder, sponsored by Purdue Pharma LP. Terminated at 35 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Purdue Pharma LP (part of Knoa Pharma) · Phase 4, Interventional, and Treatment
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.
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 267 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.
First submitted before Purdue Pharma LP became part of Knoa Pharma.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Suicidal Ideation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adhansia XR capsules taken orally once daily with or without food.
Drug: Adhansia XR
Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.
Drug: Concerta
Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)
Also known as: Methylphenidate hydrochloride (HCl) extended release
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)
Also known as: Methylphenidate hydrochloride (HCl)
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.
Time frame: Baseline to Month-2
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Months -2, -4, and -6
First patient first visit was 30-Jul-2020; primary completion date was 22-Dec-2021 (i.e., the adult portion was completed). This study was statistically powered to conduct a separate analysis for adult and adolescent patients. However, enrollment of adolescents was unexpectedly slow as a result of the Coronavirus Disease 2019 (COVID-19) pandemic and a business decision was made on 31-Jan-2022 to discontinue enrollment of adolescents, thus terminating this branch of the study.
| Milestone | Adhansia XR | Concerta |
|---|---|---|
| Started | 133 | 134 |
| Completed | 83 | 86 |
| Not completed | 50 | 48 |
| Withdrew: Adverse event | 8 | 13 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 15 | 14 |
| Withdrew: Poor compliance with protocol | 2 | 4 |
| Withdrew: Other (e.g., pi judgment, moved out of state. etc.) | 4 | 3 |
| Withdrew: Withdrawal of patient consent | 21 | 13 |
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.
| score on a scale | Adhansia XR |
|---|---|
| Total Score at baseline | 34.6 ± 8.60 |
| Total Score at Month 2 | 18.7 ± 9.01 |
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.
| score on a scale | Adhansia XR | Concerta |
|---|---|---|
| Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority | 20.2 ± 0.93 | 22.1 ± 0.88 |
The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.
| score on a scale | Adhansia XR | Concerta |
|---|---|---|
| Baseline | 4.6 ± 0.08 | 4.6 ± 0.07 |
| Month 2 | 3.1 ± 0.09 | 3.2 ± 0.08 |
| Month 4 | 2.7 ± 0.09 | 3.0 ± 0.09 |
| Month 6 | 2.7 ± 0.09 | 3.1 ± 0.09 |
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.
| score on a scale | Adhansia XR | Concerta |
|---|---|---|
| Month 2 | 2.3 ± 0.10 | 2.3 ± 0.09 |
| Month 4 | 2.0 ± 0.09 | 2.2 ± 0.09 |
| Month 6 | 2.0 ± 0.11 | 2.3 ± 0.10 |
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.
| score on a scale | Adhansia XR | Concerta |
|---|---|---|
| Global Satisfaction at Month 1 | 84.8 ± 1.60 | 84.3 ± 1.55 |
| Global Satisfaction at Month 2 | 85.2 ± 1.83 | 82.8 ± 1.82 |
| Global Satisfaction at Month 6 | 86.2 ± 1.98 | 84.3 ± 1.92 |
| Effectiveness at Month 1 | 51.3 ± 1.91 | 52.4 ± 1.84 |
| Effectiveness at Month 2 | 61.1 ± 1.94 | 58.8 ± 1.92 |
| Effectiveness at Month 6 | 63.9 ± 2.69 | 61.9 ± 2.61 |
| Side Effects at Month 1 | 74.0 ± 2.93 | 69.6 ± 2.82 |
| Side Effects at Month 2 | 72.0 ± 3.26 | 67.6 ± 3.24 |
| Side Effects at Month 6 | 70.7 ± 3.48 | 74.1 ± 3.37 |
| Convenience at Month 1 | 58.9 ± 1.81 | 59.2 ± 1.63 |
| Convenience at Month 2 | 57.0 ± 1.90 | 58.7 ± 1.78 |
| Convenience at Month 6 | 59.7 ± 2.10 | 57.0 ± 2.13 |
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.
| Visits or Inpatient Admissions | Adhansia XR | Concerta |
|---|---|---|
| Baseline (past 6 months) Overall Total Visits or Inpatient Admissions | 2.14 ± 0.314 | 2.93 ± 0.314 |
| Month 2 - Overall Total Visits or Inpatient Admissions | 2.26 ± 0.542 | 2.43 ± 0.481 |
| Month 4 - Overall Total Visits or Inpatient Admissions | 1.67 ± 0.474 | 1.73 ± 0.504 |
| Month 6 - Overall Total Visits or Inpatient Admissions | 1.34 ± 0.515 | 1.85 ± 0.480 |
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.
| score on a scale | Adhansia XR | Concerta |
|---|---|---|
| Total Score at Baseline | 41.1 ± 1.19 | 41.1 ± 1.16 |
| Total Score at Month 1 | 55.5 ± 1.24 | 55.0 ± 1.20 |
| Total Score at Month 2 | 63.0 ± 1.31 | 59.1 ± 1.29 |
| Total Score at Month 3 | 63.4 ± 1.38 | 60.9 ± 1.30 |
| Total Score at Month 4 | 64.7 ± 1.43 | 61.8 ± 1.36 |
| Total Score at Month 5 | 66.3 ± 1.44 | 60.2 ± 1.39 |
| Total Score at Month 6 | 67.4 ± 1.52 | 63.6 ± 1.48 |
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.
| percentage of impairment | Adhansia XR | Concerta |
|---|---|---|
| Percent work time missed due to health (Absenteeism) - Baseline | 5.4 ± 1.26 | 5.6 ± 1.28 |
| Percent work time missed due to health (Absenteeism) - Month 2 | 4.2 ± 1.48 | 3.7 ± 1.64 |
| Percent work time missed due to health (Absenteeism) - Month 3 | 3.0 ± 1.57 | 3.2 ± 1.62 |
| Percent work time missed due to health (Absenteeism) - Month 4 | 2.4 ± 1.61 | 4.7 ± 1.72 |
| Percent work time missed due to health (Absenteeism) - Month 5 | 4.8 ± 1.62 | 4.9 ± 1.70 |
| Percent work time missed due to health (Absenteeism) - Month 6 | 2.9 ± 1.72 | 4.1 ± 1.82 |
| Percent impairment while working due to health (Presenteeism) - Baseline | 32.0 ± 2.16 | 33.3 ± 2.18 |
| Percent impairment while working due to health (Presenteeism) - Month 2 | 19.7 ± 2.52 | 24.2 ± 2.69 |
| Percent impairment while working due to health (Presenteeism) - Month 3 | 20.1 ± 2.73 | 25.0 ± 2.70 |
| Percent impairment while working due to health (Presenteeism) - Month 4 | 13.5 ± 2.75 | 24.6 ± 2.91 |
| Percent impairment while working due to health (Presenteeism) - Month 5 | 17.8 ± 2.76 | 18.3 ± 2.90 |
| Percent impairment while working due to health (Presenteeism) - Month 6 | 15.9 ± 2.91 | 17.6 ± 3.14 |
| Percent overall work impairment due to health - Baseline | 34.1 ± 2.31 | 35.5 ± 2.34 |
| Percent overall work impairment due to health - Month 2 | 22.4 ± 2.71 | 27.2 ± 2.93 |
| Percent overall work impairment due to health - Month 3 | 21.8 ± 2.94 | 26.4 ± 2.94 |
| Percent overall work impairment due to health - Month 4 | 15.8 ± 2.94 | 25.3 ± 3.16 |
| Percent overall work impairment due to health - Month 5 | 19.7 ± 2.98 | 19.5 ± 3.17 |
| Percent overall work impairment due to health - Month 6 | 18.4 ± 3.15 | 18.9 ± 3.37 |
| Percent activity impairment due to health - Baseline | 39.7 ± 2.05 | 40.9 ± 1.98 |
| Percent activity impairment due to health - Month 2 | 26.1 ± 2.33 | 30.1 ± 2.30 |
| Percent activity impairment due to health - Month 3 | 26.1 ± 2.44 | 27.1 ± 2.29 |
| Percent activity impairment due to health - Month 4 | 19.5 ± 2.52 | 28.6 ± 2.45 |
| Percent activity impairment due to health - Month 5 | 23.6 ± 2.54 | 26.3 ± 2.43 |
| Percent activity impairment due to health - Month 6 | 21.9 ± 2.72 | 23.5 ± 2.60 |
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.
| score on a scale | Adhansia XR | Concerta |
|---|---|---|
| Global PSQI - Baseline | 9.68 ± 0.219 | 9.59 ± 0.209 |
| Global PSQI - Month 2 | 7.92 ± 0.251 | 9.59 ± 0.209 |
| Global PSQI - Month 4 | 8.11 ± 0.268 | 7.76 ± 0.252 |
| Global PSQI - Month 6 | 7.92 ± 0.284 | 7.80 ± 0.273 |
Collected over All adverse events were reported starting from the time informed consent for study participation up to 6 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adhansia XR | 0/133 (0%) | 3/133 (2.3%) | 28/133 (21.1%) |
| Concerta | 1/134 (0.7%) | 4/134 (3%) | 27/134 (20.1%) |
| Event | Adhansia XR | Concerta |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 3/133 | 3/134 |
| DelusionPsychiatric disorders | 1/133 | 0/134 |
| Hallucination, auditoryPsychiatric disorders | 1/133 | 0/134 |
| DeathGeneral disorders | 0/133 | 1/134 |
| Event | Adhansia XR | Concerta |
|---|---|---|
| InsomniaPsychiatric disorders | 13/133 | 5/134 |
| AnxietyPsychiatric disorders | 5/133 | 11/134 |
| Decreased appetiteMetabolism and nutrition disorders | 10/133 | 10/134 |
| HeadacheNervous system disorders | 4/133 | 7/134 |
| Dry MouthGastrointestinal disorders | 6/133 | 7/134 |
| Age, Continuous(years) | Adhansia XR | Concerta | Total |
|---|---|---|---|
| Mean | 36.9 ± 11.7 | 38.6 ± 12.5 | 37.7 ± 12.1 |
| Sex: Female, Male(Participants) | Adhansia XR | Concerta | Total |
|---|---|---|---|
| Female | 71 | 73 | 144 |
| Male | 62 | 61 | 123 |
| Race/Ethnicity, Customized(Participants) | Adhansia XR | Concerta | Total |
|---|---|---|---|
| Black or African American | 15 | 11 | 26 |
| White | 108 | 116 | 224 |
| Other | 10 | 7 | 17 |
| Race/Ethnicity, Customized(Participants) | Adhansia XR | Concerta | Total |
|---|---|---|---|
| Hispanic or Latino | 23 | 21 | 44 |
| Not Hispanic or Latino | 108 | 113 | 221 |
| Not Reported | 2 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2020 to primary completion in Dec 2021, 16 months.
Results were first posted in Jul 2023, 1 year 7 months after primary completion.
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Studies of the drug tested here: Methylphenidate
Attention Deficit Disorder with Hyperactivity →