Phase III randomized double-blind placebo-controlled study of Diazoxide Choline Controlled-Release (DCCR)in the patients with Prader-Willi syndrome (PWS).
Phase of Trial: Phase III
Latest Information Update: 22 Nov 2017
At a glance
- Drugs Diazoxide (Primary)
- Indications Prader-Willi syndrome
- Focus Registrational; Therapeutic Use
- Sponsors Soleno Therapeutics
- 22 Nov 2017 According to a Soleno Therapeutics media release, the company is advancing the DCCR phase III clinical program in Prader-Willi syndrome in early 2018.
- 12 Oct 2017 According to a Soleno Therapeutics media release, this trial is expected to be initiated at the end of 2017.
- 25 Sep 2017 According to a Soleno Therapeutics media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advised that a single pivotal trial would support a Marketing Authorisation Application of diazoxide choline controlled-release for the treatment of Prader-Willi syndrome. Data from this study will support Marketing Authorisation Application.Company has recieved advise from EMA and FDA regarding this study.