NCT04507204

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Adhansia XR	Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)
DRUG	Concerta	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)

Timeline

• Start date: 2020-07-30
• Primary completion: 2021-12-22
• Completion: 2022-01-31
• First posted: 2020-08-11
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study