drugset / Trial / NCT02821715

Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

NCT02821715

Phase 2 Completed 51 enrolled Theranexus
RandomizedCrossoverQuadruple-blindTreatment

Summary

This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).

Timeline

Start
2016-09
Primary completion
2018-12
Completion
2019-02

Drugs

EvaluationDrugModalityDoseRoute
Subject flecainide Small molecule 3 mg
Subject flecainide Small molecule 27 mg
Comparator Modafinil Small molecule 300 mg

Indications