The first European approval for a Phase II clinical trial with THN102 in Parkinson’s patients has been announced by biopharmaceutical company, Theranexus.
Parkinson's treatment
This study, which has been approved by the Hungarian Medicines Agency, will investigate the safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson's disease. The randomised, double-blind, placebo-controlled, complete three-way cross-over trial will be coordinated by Professor Jean-Christophe Corvol of Pitié Salpêtrière Hospital in Paris, and will be conducted in more than 20 centres in Europe (France, Germany, Hungary, Czech Republic) and the US.
Before the geographical footprint of the study can be finalised, however, the national regulatory authorisations of other countries are being waited upon.
“We would like to thank the regulatory agencies with whom we are in contact and we are delighted with this first authorisation for the phase 2 study for our drug candidate THN102 in Parkinson's disease,” said Franck Mouthon, chief executive officer of Theranexus.
The results of this study are expected in the second quarter of 2019.