Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD)

Summary

The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD

Timeline

Start

2011-02

Primary completion

2011-08

Completion

2011-09

Outcome

Met primary endpoint

registry METADOXINE(MG01CI) vs Placebo; p = 0.0093; Median NCT01243242 ↗

release “Results showed MG01CI met the primary efficacy outcome” tevapharm.com ↗

Publications

• Manor I, Newcorn JH, Faraone SV, Adler LA. Efficacy of metadoxine extended release in patients with predominantly inattentive subtype attention-deficit/hyperactivity disorder. Postgrad Med. 2013 Jul;125(4):181-90. doi: 10.3810/pgm.2013.07.2689.
• Manor I, Ben-Hayun R, Aharon-Peretz J, Salomy D, Weizman A, Daniely Y, Megiddo D, Newcorn JH, Biederman J, Adler LA. A randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of extended-release metadoxine in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Dec;73(12):1517-23. doi: 10.4088/JCP.12m07767.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metadoxine	Unknown	1400 mg	Oral

Indications