RO7248824 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
201アンジェルマン症候群5

201. アンジェルマン症候群


臨床試験数 : 25 薬物数 : 40 - (DrugBank : 11) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 20
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04863794
(ClinicalTrials.gov)
April 29, 202126/4/2021A Study To Assess Distribution Of RO7248824 In The Central Nervous System Following Single Intrathecal Doses Of [89zr] Labeled RO7248824 In Healthy Male ParticipantsA Non-Randomized, Open-Label, Adaptive, Single Center, Positron Emission Tomography (Pet) Study To Assess Distribution Of RO7248824 In The Central Nervous System Following Single Intrathecal Doses Of [89zr] Labeled RO7248824 In Healthy Male ParticipantsAngelman SyndromeDrug: RO7248824Hoffmann-La RocheNULLCompleted25 Years55 YearsMale21Phase 1Netherlands
2EUCTR2019-003787-48-NL
(EUCTR)
22/09/202008/10/2020Angelman syndrome is a complex genetic disorder that primarily affects the nervous system.AN OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7248824 IN PARTICIPANTS WITH ANGELMAN SYNDROME Angelman Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: RO7248824/F02-01
INN or Proposed INN: Not available
Other descriptive name: RO7248824
Product Code: RO7248824/F03-01 (Diluent for RO7248824/F02-01
INN or Proposed INN: Not available
Other descriptive name: RO7248824
F. Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 1United States;Canada;Spain;Netherlands;United Kingdom;Italy
3NCT04428281
(ClinicalTrials.gov)
August 19, 20209/6/2020A Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of RO7248824 In Participants With Angelman SyndromeAn Open-Label, Multicenter Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of RO7248824 In Participants With Angelman SyndromeAngelman SyndromeDrug: RO7248824Hoffmann-La RocheNULLRecruiting1 Year12 YearsAll74Phase 1United States;Italy;Netherlands;Spain;Canada;United Kingdom
4EUCTR2019-003787-48-IT
(EUCTR)
03/07/202015/06/2021Angelman syndrome is a complex genetic disorder that primarily affects the nervous system.AN OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7248824 IN PARTICIPANTS WITH ANGELMAN SYNDROME - TANGELO Angelman Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: -
Product Code: [RO7248824/F02-01]
INN or Proposed INN: Non disponibile
Other descriptive name: RO7248824
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 1United States;Canada;Spain;Netherlands;United Kingdom;Italy
5EUCTR2019-003787-48-GB
(EUCTR)
11/06/202016/03/2020Angelman syndrome is a complex genetic disorder that primarily affects the nervous system.AN OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7248824 IN PARTICIPANTS WITH ANGELMAN SYNDROME Angelman Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: RO7248824/F02-01
INN or Proposed INN: Not available
Other descriptive name: RO7248824
Product Code: RO7248824/F03-01 (Diluent for RO7248824/F02-01
INN or Proposed INN: Not available
Other descriptive name: RO7248824
F. Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 1United States;Canada;Spain;Netherlands;Italy;United Kingdom