Trial · NCT04507204
Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT04507204, Phase 4, Terminated, Purdue Pharma LP; results first posted 2023-07-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT04507204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04507204
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT04507204
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 267 participants, actual
- Lead sponsor
- Purdue Pharma LP
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Interventions
- Adhansia XR, Concerta
- First posted
- 2020-08-11
- Last updated
- 2023-07-27
- Results first posted
- 2023-07-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR | 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. |
| Secondary | Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority | Month-2 | 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. |
| Secondary | Assessment of Clinical Global Impression-Severity (CGI-S) | Baseline, Month-2, Month-4, and Month-6 | The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity. |
| Secondary | Assessment of Clinical Global Impression-Improvement (CGI-I) | Month-2, Month-4, and Month-6 | The CGI-I measures global improvement prior to and after initiating the study medication. 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. |
| Secondary | Assessment of Treatment Satisfaction | Month-1, Month-2, and Month-6 | The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication 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. |
| Secondary | Healthcare Resource Utilization (HCRU) | Baseline (past 6 months) Months -2, -4, and -6 | 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. |
| Secondary | Adult ADHD Quality of Life Scale - Revised (AAQoL-R) | Baseline, Months -1, -2, -3, -4, -5 and -6 | Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life. |
| Secondary | Work Productivity and Activity Impairment (WPAI) Questionnaire | Baseline, Months -2, -3, -4, -5, and -6 | 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. |
| Secondary | Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) | Baseline and Months -2, -4, and -6 | The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates "poor" from "good" sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR | Baseline to Month-2 | 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. | score on a scale | MEAN |
| SECONDARY | Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority | Month-2 | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Assessment of Clinical Global Impression-Severity (CGI-S) | Baseline, Month-2, Month-4, and Month-6 | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Assessment of Clinical Global Impression-Improvement (CGI-I) | Month-2, Month-4, and Month-6 | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Assessment of Treatment Satisfaction | Month-1, Month-2, and Month-6 | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Healthcare Resource Utilization (HCRU) | Baseline (past 6 months) Months -2, -4, and -6 | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | Visits or Inpatient Admissions | LEAST_SQUARES_MEAN |
| SECONDARY | Adult ADHD Quality of Life Scale - Revised (AAQoL-R) | Baseline, Months -1, -2, -3, -4, -5 and -6 | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Work Productivity and Activity Impairment (WPAI) Questionnaire | Baseline, Months -2, -3, -4, -5, and -6 | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | percentage of impairment | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) | Baseline and Months -2, -4, and -6 | FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR | Adhansia XR | Total Score at baseline | 34.6 | Standard Deviation 8.60 | score on a scale |
| Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR | Adhansia XR | Total Score at Month 2 | 18.7 | Standard Deviation 9.01 | score on a scale |
| Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority | Adhansia XR | 20.2 | Standard Error 0.93 | score on a scale | |
| Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority | Concerta | 22.1 | Standard Error 0.88 | score on a scale | |
| Assessment of Clinical Global Impression-Severity (CGI-S) | Adhansia XR | Baseline | 4.6 | Standard Error 0.08 | score on a scale |
| Assessment of Clinical Global Impression-Severity (CGI-S) | Concerta | Baseline | 4.6 | Standard Error 0.07 | score on a scale |
| Assessment of Clinical Global Impression-Severity (CGI-S) | Adhansia XR | Month 2 | 3.1 | Standard Error 0.09 | score on a scale |
| Assessment of Clinical Global Impression-Severity (CGI-S) | Concerta | Month 2 | 3.2 | Standard Error 0.08 | score on a scale |
| Assessment of Clinical Global Impression-Severity (CGI-S) | Adhansia XR | Month 4 | 2.7 | Standard Error 0.09 | score on a scale |
| Assessment of Clinical Global Impression-Severity (CGI-S) | Concerta | Month 4 | 3.0 | Standard Error 0.09 | score on a scale |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adhansia XR | 133 | |
| Overall Study | STARTED | Concerta | 134 | |
| Overall Study | COMPLETED | Adhansia XR | 83 | |
| Overall Study | COMPLETED | Concerta | 86 | |
| Overall Study | NOT COMPLETED | Adhansia XR | 50 | |
| Overall Study | NOT COMPLETED | Concerta | 48 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased appetite | Metabolism and nutrition disorders | Adhansia XR | 10 | 133 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Concerta | 10 | 134 | |
| other | Anxiety | Psychiatric disorders | Adhansia XR | 5 | 133 | |
| other | Anxiety | Psychiatric disorders | Concerta | 11 | 134 | |
| other | Insomnia | Psychiatric disorders | Adhansia XR | 13 | 133 | |
| other | Insomnia | Psychiatric disorders | Concerta | 5 | 134 | |
| other | Headache | Nervous system disorders | Adhansia XR | 4 | 133 | |
| other | Headache | Nervous system disorders | Concerta | 7 | 134 | |
| other | Dry Mouth | Gastrointestinal disorders | Adhansia XR | 6 | 133 | |
| other | Dry Mouth | Gastrointestinal disorders | Concerta | 7 | 134 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adhansia XR | 0 | 133 |
| Total, all-cause mortality | Concerta | 1 | 134 |
| Total, other adverse events | Adhansia XR | 28 | 133 |
| Total, other adverse events | Concerta | 27 | 134 |
| Total, serious adverse events | Adhansia XR | 3 | 133 |
| Total, serious adverse events | Concerta | 4 | 134 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35201607 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adhansia XR vs Concerta: deaths from any cause | Trial comparisons |
| Adhansia XR vs Concerta: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04507204
GET https://conductscience.org/api/trials/v1/NCT04507204/results?page=2