Phase III randomized double-blind placebo-controlled study of Diazoxide Choline Controlled-Release (DCCR)in the patients with Prader-Willi syndrome (PWS).

Trial Profile

Phase III randomized double-blind placebo-controlled study of Diazoxide Choline Controlled-Release (DCCR)in the patients with Prader-Willi syndrome (PWS).

Planning
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
  • Most Recent Events

    • 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.
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