Date: 2016-10-27
Type of information: Treatment of the first patient
phase: 2
Announcement:
Company: Theranexus (France)
Product: THN102 - combination of modafinil and flecainide
Action
mechanism: THN102 is the first to represent a new class of innovative therapeutic combinations that associate a neural activity modulator, in this case modafinil (Provigil®, Alertec®, Modavigil®), with a glial connexin modulator which, in the case of THN102, is low-dose flecainide. THN102 has shown its superior efficacy compared to modafinil alone in in vivo narcolepsy models (Duchêne et al. 2016), as well as in healthy, sleep-deprived volunteers (ESRS, September 2016).
Disease: narcolepsy
Therapeutic area: Rare diseases - Neurological diseases
Country: France
Trial
details: This phase II study is entitled “safety and efficacy of THN102 on sleepiness in narcolepsy patients. The study is a 3-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). (NCT02821715)
Latest
news: * On October 27, 2016, Theranexus announced that the first patient has been recruited in a phase II clinical study evaluating theefficacy and tolerance of THN102 in the treatment of excessive daytime sleepiness associated This study, which is being financed in part by the French National Research Agency (ANR, project NarConX), will enroll in total 48 patients at three French centres, those being Montpellier Regional University Hospital (Professor Yves Dauvilliers – Principal investigator for the study), the Paris public hospital organisation APHP (Dr Isabelle Arnulf) and Lille Regional University Hospital (Dr Christelle Charley-Monaca).
with narcolepsy in adult patients. This double-blind study will compare two different doses of THN102 with an active comparator, modafinil - the standard of care drug for treating sleepiness in narcolepsy patients. The protocol is being conducted according to a design referred to as crossover: a study design in which each patient will receive all of the proposed treatments over successive treatment periods. The main objective of the study is to show a decrease in sleepiness as measured by the Epworth Sleepiness Scale (ESS) - the reference scale for measuringsleepiness in narcolepsy patients.
