An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
Phase of Trial: Phase III
Latest Information Update: 02 Dec 2019
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At a glance
- Drugs Hydrocortisone (Primary) ; Dexamethasone; Hydrocortisone; Prednisolone; Prednisone
- Indications Congenital adrenal hyperplasia
- Focus Registrational; Therapeutic Use
- Acronyms RESTORE
- Sponsors Diurnal
- 02 Dec 2019 According to a Diurnal media release, it has submitted a New Drug Application (NDA), under section 505(b)(2) of the Federal Food Drug and Cosmetic Act, to the US Food and Drug Administration (FDA) for the regulatory approval of Alkindi Sprinkle (hydrocortisone granules in capsules for opening) as a replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to <17 years old) in the US.
- 23 Oct 2018 Planned End Date changed from 1 Oct 2020 to 1 Oct 2021.
- 23 Oct 2018 Planned primary completion date changed from 1 Oct 2019 to 1 Oct 2021.