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(due to administrative reasons not related to efficacy or safety.)
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adhansia XR | Experimental | Adhansia XR capsules taken orally once daily with or without food. |
|
| Concerta | Active Comparator | Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhansia XR | Drug | Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Month-2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex, Inc. | Dothan | Alabama | 36303 | United States | ||
| Southern California Research LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35201607 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adhansia XR | Methylphenidate extended-release capsules taken once daily. |
| FG001 | Concerta | Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2020 |
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| Concerta | Drug | 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) |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and Months -2, -4, and -6 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| CT Clinical Research | Cromwell | Connecticut | 06416 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Reliable Clinical Research, LLC | Hialeah | Florida | 33012 | United States |
| Eastern Research. Inc. | Hialeah | Florida | 33013 | United States |
| Wellness Research Center Inc. | Miami | Florida | 33135 | United States |
| AdventHealth Medical Group Pediatrics at Orange City | Orange City | Florida | 32763 | United States |
| Pediatric Epilepsy & Neurology Specialists | Tampa | Florida | 33609 | United States |
| Clinical Integrative Research Center of Atlanta | Atlanta | Georgia | 30328 | United States |
| Revive Research Institute | Elgin | Illinois | 60123 | United States |
| AMR-Baber Research Inc. | Naperville | Illinois | 60563 | United States |
| BTC of New Bedford, LLC | New Bedford | Massachusetts | 02740 | United States |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Clinical Research of Southern Nevada, LLC | Las Vegas | Nevada | 89128 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Bioscience Research, LLC | Mount Kisco | New York | 10549 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Mid-Ohio Behavioral Health | Columbus | Ohio | 43205 | United States |
| SFM Clinical Trials | Scotland | Pennsylvania | 17254 | United States |
| Rainbow Research | Barnwell | South Carolina | 29812 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | United States |
| Family Psychiatry of the Woodlands | The Woodlands | Texas | 77381 | United States |
| Dixie Pediatrics | St. George | Utah | 84790 | United States |
| Clinical Research Partners, LLC | Petersburg | Virginia | 23805 | United States |
| Eastside Therapeutic Resource Inc dba Core Clinical Research | Everett | Washington | 98201 | United States |
| MultiCare Health System - Rockwood Clinic | Spokane | Washington | 99202 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adhansia XR | Methylphenidate extended-release capsules taken once daily. |
| BG001 | Concerta | Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS) Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month-2 |
|
|
| |||||||||||||||||||||||||||
| Secondary | 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. | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Month-2 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month-2, Month-4, and Month-6 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Month-2, Month-4, and Month-6 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Month-1, Month-2, and Month-6 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | Visits or Inpatient Admissions | Baseline (past 6 months) Months -2, -4, and -6 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Months -1, -2, -3, -4, -5 and -6 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | percentage of impairment | Baseline, Months -2, -3, -4, -5, and -6 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Months -2, -4, and -6 |
|
|
All adverse events were reported starting from the time informed consent for study participation up to 6 months.
Since participants may have received multiple dose levels during the study and a participant may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adhansia XR | Methylphenidate extended-release capsules taken once daily. | 0 | 133 | 3 | 133 | 28 | 133 |
| EG001 | Concerta | Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food. | 1 | 134 | 4 | 134 | 27 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delusion | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaromir Mikl, PhD MSPH | Purdue Pharma L.P. | 800-745-7445 | 7277 | jaromir.mikl@pharma.com |
| Jun 8, 2023 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| White |
|
| Other |
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| Not Hispanic or Latino |
|
| Not Reported |
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