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

Phase 4 Terminated 267 enrolled Purdue Pharma LP

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2020-07-30
Primary completion: 2021-12-22
Completion: 2022-01-31

Outcome

Outcome not reported

Stopped: “(due to administrative reasons not related to efficacy or safety.)”

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	18 mg	Oral
Subject	Methylphenidate	Small molecule	25 mg	Oral
Subject	Methylphenidate	Small molecule	27 mg	Oral
Subject	Methylphenidate	Small molecule	35 mg	Oral
Subject	Methylphenidate	Small molecule	36 mg	Oral
Subject	Methylphenidate	Small molecule	45 mg	Oral
Subject	Methylphenidate	Small molecule	54 mg	Oral
Subject	Methylphenidate	Small molecule	55 mg	Oral
Subject	Methylphenidate	Small molecule	70 mg	Oral
Subject	Methylphenidate	Small molecule	85 mg	Oral