A double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS).
Phase of Trial: Phase II
Latest Information Update: 17 May 2017
At a glance
- Drugs Metoprolol/tesofensine (Primary)
- Indications Prader-Willi syndrome
- Focus Therapeutic Use
- Sponsors Saniona
- 03 Apr 2017 Status changed to recruiting, according to a Saniona media release.
- 20 Mar 2017 According to a Saniona media release, based on company's meeting with the European Medicines Agency (EMA) for scientific advice and now collaborates with an international consortium to advance clinical trials for Prader-Willi syndrome, it has decided to include additional clinical endpoints and a questionnaire, was developed and validated for assessing changes in hyperphagic behavior in PWS patients, a critical issue in their daily lives.
- 20 Mar 2017 According to a Saniona media release, the regulatory agencies in Czech Republic and Hungary have approved company's clinical trial applications and the trial is expected to be initiated in the second quarter of 2017.