A Randomized, Double-Blind Study of the Time Course of Response to Biphentin Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting.
Phase of Trial: Phase III
Latest Information Update: 01 Dec 2016
At a glance
- Drugs Methylphenidate (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- Sponsors Rhodes Pharmaceuticals
- 22 May 2015 Aptensio XR [methyphenidate extended release] was approved by the U.S. FDA based on the data from this and another phase III trial [see CT profile 700191334].
- 22 May 2015 Primary endpoint of 'Comparison following treatment between drug and placebo using evaluation by SKAMP Combined, Attention, and Deportment Scales' has been met, according to a Rhodes Pharmaceuticals media release.
- 23 Jan 2013 Actual end date changed from Aug 2011 to Feb 2012, as reported by ClinicalTrials.gov.