8. ハンチントン病 Huntington disease Clinical trials / Disease details


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

  
15 trials found
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PhaseCountries
1EUCTR2018-003898-94-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
2EUCTR2018-003898-94-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
3EUCTR2018-003898-94-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
4NCT04000594
(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
5EUCTR2018-002987-14-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
6EUCTR2018-003898-94-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
7NCT03842969
(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
8EUCTR2018-002987-14-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
9EUCTR2018-002987-14-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
10EUCTR2018-002987-14-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
11EUCTR2018-003898-94-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
12EUCTR2018-002987-14-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
13EUCTR2018-002987-14-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
14NCT03761849
(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
15NCT03342053
(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