Tominersen ( 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 | 6 |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05686551 (ClinicalTrials.gov) | January 30, 2023 | 16/12/2022 | GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease. | A 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 Disease | Drug: Tominersen 60 mg;Drug: Placebo;Drug: Tominersen 100 mg | Hoffmann-La Roche | NULL | Recruiting | 25 Years | 50 Years | All | 360 | Phase 2 | United States;Spain |
| 2 | EUCTR2022-001991-32-ES (EUCTR) | 22/12/2022 | 23/12/2022 | A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen in Individuals with Prodromal and Early Manifest Huntington’s Disease | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | Canada;Argentina;Spain;Australia;United Kingdom;New Zealand;Japan | ||
| 3 | EUCTR2018-003898-94-IT (EUCTR) | 30/12/2020 | 15/06/2021 | An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease | AN 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. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 4 | EUCTR2018-003898-94-AT (EUCTR) | 10/12/2020 | 14/10/2020 | An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease | AN 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 5 | EUCTR2018-003898-94-NL (EUCTR) | 01/10/2020 | 08/10/2020 | An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease | AN 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Phase 3 | United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand | ||
| 6 | EUCTR2018-003898-94-GB (EUCTR) | 07/03/2019 | 13/12/2018 | An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease | AN 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Spain;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand |