A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants

NCT01933880 ↗

Phase 4 Completed 194 enrolled Xian-Janssen Pharmaceutical Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder (ADHD).

Timeline

Start: 2009-12
Primary completion: 2010-11
Completion: 2010-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); OROS-MPH Group; p = 0.0387; Signed Rank Sum Test NCT01933880 ↗

paper Digit Span Test scores improved significantly (P < 0.0001) with a high remission rate (81.1%) at week 12 versus baseline. PMID 26608976 ↗

Publications

Zheng Y, Liang JM, Gao HY, Yang ZW, Jia FJ, Liang YZ, Fang F, Li R, Xie SN, Zhuo JM. An Open-label, Self-control, Prospective Study on Cognitive Function, Academic Performance, and Tolerability of Osmotic-release Oral System Methylphenidate in Children with Attention-deficit Hyperactivity Disorder. Chin Med J (Engl). 2015 Nov 20;128(22):2988-97. doi: 10.4103/0366-6999.168948.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	18 mg	Oral
Subject	Methylphenidate	Small molecule	36 mg	Oral
Subject	Methylphenidate	Small molecule	54 mg	Oral