Trial Profile

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

Status: Withdrawn prior to enrolment

Phase of Trial: Phase III

Latest Information Update: 13 Apr 2022

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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

31 Mar 2022 Status changed from discontinued to withdrawn prior to enrolment.
18 Feb 2022 Status changed from suspended to discontinued.
29 Sep 2020 According to an Eton Pharmaceuticals media release, based on the data from this study, the U.S. Food and Drug Administration (FDA) has approved ALKINDI SPRINKLE (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.

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