RO7234292 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
8ハンチントン病18

8. ハンチントン病


臨床試験数 : 242 薬物数 : 205 - (DrugBank : 62) / 標的遺伝子数 : 85 - 標的パスウェイ数 : 159
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2022-001991-32-ES
(EUCTR)
22/12/202223/12/2022A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen in Individuals with Prodromal and Early Manifest Huntington’s DiseaseA PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, BIOMARKERS, AND EFFICACY OF TOMINERSEN IN INDIVIDUALS WITH PRODROMAL AND EARLY MANIFEST HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: RO7234292
INN or Proposed INN: Tominersen
Other descriptive name: N/A
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Canada;Argentina;Spain;Australia;United Kingdom;New Zealand;Japan
2EUCTR2018-003898-94-IT
(EUCTR)
30/12/202015/06/2021An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE - NA Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;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: [Ro 723-4292/F02]
INN or Proposed INN: tominersen
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
3EUCTR2018-003898-94-AT
(EUCTR)
10/12/202014/10/2020An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: tominersen
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
4EUCTR2018-003898-94-NL
(EUCTR)
01/10/202008/10/2020An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: tominersen
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1050Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand
5NCT04000594
(ClinicalTrials.gov)
September 2, 201926/6/2019A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's DiseaseAn Open-Label Adaptive Multiple-Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's DiseaseHuntingtons DiseaseDrug: RO7234292 (RG6042)Hoffmann-La RocheNULLCompleted25 Years65 YearsAll12Phase 1Netherlands;United Kingdom
6EUCTR2018-002987-14-NL
(EUCTR)
23/07/201925/02/2019A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Netherlands;United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;New Zealand
7EUCTR2018-003898-94-ES
(EUCTR)
21/06/201911/06/2019An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTDNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Spain;Austria;Russian Federation;Chile;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
8NCT03842969
(ClinicalTrials.gov)
April 23, 201911/2/2019An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored StudiesAn Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients With Huntington's DiseaseHuntington DiseaseDrug: RO7234292 (RG6042)Hoffmann-La RocheNULLCompleted25 YearsN/AAll236Phase 3United States;Austria;Canada;Germany;Italy;Netherlands;Spain;United Kingdom;Argentina;Australia;Chile;Japan;Poland
9EUCTR2018-002987-14-DK
(EUCTR)
11/04/201915/02/2019A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Denmark;Australia;Netherlands;Germany;China;Japan;New Zealand
10EUCTR2018-002987-14-AT
(EUCTR)
27/03/201922/03/2019A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
11EUCTR2018-002987-14-PL
(EUCTR)
19/03/201907/04/2020A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
801Phase 3United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;New Zealand
12EUCTR2018-003898-94-GB
(EUCTR)
07/03/201913/12/2018An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: tominersen
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Spain;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
13EUCTR2018-002987-14-IT
(EUCTR)
27/02/201915/06/2021A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE. - A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Pati Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;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: [Ro 723-4292/F02]
INN or Proposed INN: -
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
801Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;Japan;New Zealand
14EUCTR2018-002987-14-GB
(EUCTR)
13/02/201908/02/2019A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
15NCT03761849
(ClinicalTrials.gov)
January 23, 201930/11/2018A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's DiseaseA Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's DiseaseHuntingtons DiseaseDrug: RO7234292;Drug: PlaceboHoffmann-La RocheNULLCompleted25 Years65 YearsAll899Phase 3United States;Argentina;Australia;Austria;Canada;Chile;Denmark;France;Germany;Italy;Japan;Netherlands;New Zealand;Poland;Russian Federation;Spain;Switzerland;United Kingdom;China
16EUCTR2017-002471-25-GB
(EUCTR)
18/10/201804/08/2017An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7234292 (ISIS 443139) IN HUNTINGTON'S DISEASE PATIENTS WHO PARTICIPATED IN PRIOR INVESTIGATIONAL STUDIES OF RO7234292 (ISIS 443139) Early Manifest Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: n.a.
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
46Phase 1;Phase 2Canada;United Kingdom;Germany
17EUCTR2017-002471-25-DE
(EUCTR)
10/01/201807/08/2017An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington’s Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139) Early Manifest Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: n.a.
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
46Phase 2Canada;Germany;United Kingdom
18NCT03342053
(ClinicalTrials.gov)
January 2, 201831/10/2017A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)Huntington's DiseaseDrug: RO7234292 (RG6042)Hoffmann-La RocheNULLCompleted25 YearsN/AAll46Phase 2Canada;Germany;United Kingdom