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Inclusion of the first patient in the phase II clinical study that aims to test THN102 in patients affected by narcolepsy

logo-theranexusThis study aims to demonstrate the superior efficacy of THN102 compared to the reference treatment in narcolepsy patients.

 


 
Lyon, October 27th 2016 – Theranexus, a clinical-stage biopharmaceutical company, announced today that the first patient has been recruited in the study entitled “safety and efficacy of THN102 on sleepiness in narcolepsy patients” (NCT02821715), a phase II clinical study evaluating the efficacy and tolerance of THN102 in the treatment of excessive daytime sleepiness associated 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 cross-over: 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 measuring sleepiness in narcolepsy patients.

 

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).

 

 

Read the press release