drugset / Trial / NCT02189772

Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects

NCT02189772

Phase 2 Completed 83 enrolled Alcobra Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of a single administration of Metadoxine Extended Release (MDX) formulation for the treatment of adolescents diagnosed with ADHD that have predominantly inattentive symptoms. The study will also try to evaluate the efficacy of MDX and its level in the blood.

Timeline

Start
2014-08
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Metadoxine Unknown 700 mg Oral
Subject Metadoxine Unknown 1050 mg Oral
Subject Metadoxine Unknown 1400 mg Oral