drugset / Trial / NCT02305134

Tipepidine in Children With Attention Deficit/Hyperactivity Disorder (AD/HD): a Double-blind, Placebo-controlled Trial

NCT02305134 ↗

Phase 1/2 Completed 21 enrolled Chiba University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Tipepidine (3-\[di-2-thienylmethylene\]-1-methylpiperidine) has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been established. It is reported that tipepidine inhibits G-protein-coupled inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by tipepidine is expected to modulate the level of monoamines in the brain. We put forward the hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD) symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD.

Timeline

Start
2015-06-11
Primary completion
2019-03
Completion
2019-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tipepidine Small molecule 10 mg Oral