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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04507204

Acronym

RE-DAX

Enrollment

267

Registered

2020-08-11

Start date

2020-07-30

Completion date

2022-01-31

Last updated

2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

ADHD, Methylphenidate, Adhansia XR, MPH, OROS, Phase IV

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.

Interventions

DRUGAdhansia XR

Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)

DRUGConcerta

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
Adhansia XR Methylphenidate extended-release capsules taken once daily.	133
Concerta Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.	134
Total	267

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	8	13
Overall Study	Death	0	1
Overall Study	Lost to Follow-up	15	14
Overall Study	Other (e.g., PI judgment, moved out of state. etc.)	4	3
Overall Study	Poor Compliance with Protocol	2	4
Overall Study	Withdrawal of Patient Consent	21	13

Baseline characteristics

Characteristic	Total	Concerta	Adhansia XR
Age, Continuous	37.7 years STANDARD_DEVIATION 12.1	38.6 years STANDARD_DEVIATION 12.5	36.9 years STANDARD_DEVIATION 11.7
Race/Ethnicity, Customized Black or African American	26 Participants	11 Participants	15 Participants
Race/Ethnicity, Customized Hispanic or Latino	44 Participants	21 Participants	23 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	221 Participants	113 Participants	108 Participants
Race/Ethnicity, Customized Not Reported	2 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Other	17 Participants	7 Participants	10 Participants
Race/Ethnicity, Customized White	224 Participants	116 Participants	108 Participants
Sex: Female, Male Female	144 Participants	73 Participants	71 Participants
Sex: Female, Male Male	123 Participants	61 Participants	62 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 133	1 / 134
other Total, other adverse events	28 / 133	27 / 134
serious Total, serious adverse events	3 / 133	4 / 134

Outcome results

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.

Time frame: Baseline to Month-2

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adhansia XR	Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR	Total Score at baseline	34.6 score on a scale	Standard Deviation 8.6
Adhansia XR	Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR	Total Score at Month 2	18.7 score on a scale	Standard Deviation 9.01

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.

Time frame: Baseline, Months -1, -2, -3, -4, -5 and -6