WHO ICTRP trial

A randomized, double-blind, placebo-controlled trial to investigate the efficacy…

EUCTR2018-003370-27-GB · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2018-003370-27-GB
Public title A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome.
Scientific title A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome.
Primary sponsor GW Research Ltd
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries United States;France;Canada;Spain;Australia;Italy;United Kingdom
Conditions Rett syndrome (RTT) [typical or atypical] MedDRA version: 20.0 Level: PT Classification code 10077709 Term: Rett syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous…
Interventions Trade Name: CBD - Oral Solution, is known as Epidyolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P Pharmaceutical Form: Oral solution INN or Proposed INN: Cannabidiol CAS Number: 13956-29-1…
Registration date Dec 24, 2018
Target size 252
Secondary IDs GWND18064
Registry page clinicaltrialsregister.eu

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