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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 267
- 试验地点
- 35
- 主要终点
- Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Adhansia XR
Adhansia XR capsules taken orally once daily with or without food.
干预措施: Adhansia XR (Drug)
Concerta
Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.
干预措施: Concerta (Drug)
结局指标
主要结局
Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR
时间窗: 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.
次要结局
- Healthcare Resource Utilization (HCRU)(Baseline (past 6 months) Months -2, -4, and -6)
- Work Productivity and Activity Impairment (WPAI) Questionnaire(Baseline, Months -2, -3, -4, -5, and -6)
- Adult ADHD Quality of Life Scale - Revised (AAQoL-R)(Baseline, Months -1, -2, -3, -4, -5 and -6)
- Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority(Month-2)
- Assessment of Clinical Global Impression-Severity (CGI-S)(Baseline, Month-2, Month-4, and Month-6)
- Assessment of Treatment Satisfaction(Month-1, Month-2, and Month-6)
- Assessment of Clinical Global Impression-Improvement (CGI-I)(Month-2, Month-4, and Month-6)
- Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Months -2, -4, and -6)