LMI070 ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 3 | 脊髄性筋萎縮症 | 10 |
| 8 | ハンチントン病 | 7 |
3. 脊髄性筋萎縮症
臨床試験数 : 217 / 薬物数 : 149 - (DrugBank : 33) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 80
| 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 | EUCTR2014-002053-19-BG (EUCTR) | 04/10/2018 | 31/07/2018 | Clinical trial of LMI070 given by mouth to Type I SMA infant patients. | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 INN or Proposed INN: Not established Other descriptive name: LMI070 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Poland;Belgium;Denmark;Russian Federation;Bulgaria;Netherlands;Germany;Italy | ||
| 2 | EUCTR2014-002053-19-HU (EUCTR) | 17/09/2018 | 17/07/2018 | Clinical trial of LMI070 given by mouth to Type I SMA infant patients. | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 Other descriptive name: LMI070 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Czech Republic;Hungary;Poland;Belgium;Denmark;Russian Federation;Bulgaria;Netherlands;Germany;Italy | ||
| 3 | EUCTR2014-002053-19-CZ (EUCTR) | 14/02/2018 | 30/10/2017 | Clinical trial of LMI070 given by mouth to Type I SMA infant patients. | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 INN or Proposed INN: Not established Other descriptive name: LMI070 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Poland;Belgium;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Italy | ||
| 4 | NCT02268552 (ClinicalTrials.gov) | April 2, 2015 | 1/10/2014 | An Open Label Study of LMI070 (Branaplam) in Type 1 Spinal Muscular Atrophy (SMA) | An Open Label Multi-part First-in-human Study of Oral LMI070 in Infants With Type 1 Spinal Muscular Atrophy | Spinal Muscular Atrophy | Drug: branaplam | Novartis Pharmaceuticals | NULL | Active, not recruiting | N/A | 182 Days | All | 40 | Phase 1/Phase 2 | Belgium;Bulgaria;Denmark;Germany;Italy;Poland;Russian Federation;Czechia;Hungary;Netherlands |
| 5 | EUCTR2014-002053-19-IT (EUCTR) | 01/04/2015 | 27/10/2014 | Clinical trial of LMI070 given my mouth to Type I SMA infant patients. | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: LMI070 INN or Proposed INN: NA Other descriptive name: NA | NOVARTIS FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 22 | Phase 1;Phase 2 | United States;Hungary;Czech Republic;European Union;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Italy | ||
| 6 | EUCTR2014-002053-19-DE (EUCTR) | 02/02/2015 | 30/10/2014 | Clinical trial of LMI070 given by mouth to Type I SMA infant patients. | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 INN or Proposed INN: Not established Other descriptive name: LMI070 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Italy | ||
| 7 | EUCTR2014-002053-19-DK (EUCTR) | 16/12/2014 | 15/10/2014 | Clinical trial of LMI070 given by mouth to Type I SMA infant patients. | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 INN or Proposed INN: Not established Other descriptive name: LMI070 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 1;Phase 2 | United States;Hungary;Czech Republic;Poland;Belgium;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Italy | ||
| 8 | EUCTR2014-002053-19-BE (EUCTR) | 15/12/2014 | 04/11/2014 | Clinical trial of LMI070 given by mouth to Type I SMA infant patients. | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 INN or Proposed INN: Branaplam Other descriptive name: LMI070 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 1;Phase 2 | United States;Hungary;Czech Republic;Poland;Belgium;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Italy | ||
| 9 | EUCTR2014-002053-19-PL (EUCTR) | 03/01/2018 | Clinical trial of LMI070 given by mouth to Type I SMA infant patients. | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 INN or Proposed INN: Branaplam Other descriptive name: LMI070 | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 44 | Phase 1;Phase 2 | United States;Hungary;Czech Republic;Belgium;Poland;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Italy | |||
| 10 | EUCTR2014-002053-19-NL (EUCTR) | 27/11/2014 | Clinical trial of LMI070 given by mouth to Type I SMA infant patients | An open-label multi-part first-in-human study of oral LMI070 in infants with Type 1 spinal muscular atrophy - CLMI070X2201 | Spinal Muscular Atrophy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 INN or Proposed INN: LMI070 | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 22 | Phase 1;Phase 2 | United States;Belgium;Denmark;Germany;Netherlands;Italy |
8. ハンチントン病
臨床試験数 : 229 / 薬物数 : 193 - (DrugBank : 60) / 標的遺伝子数 : 84 - 標的パスウェイ数 : 158
| 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 | EUCTR2020-000105-92-LT (EUCTR) | 02/03/2022 | 28/10/2021 | A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease | 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] - Nervous System Diseases [C10] | Product Name: branaplam Product Code: LMI070 INN or Proposed INN: BRANAPLAM | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | France;United States;Hungary;Canada;Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy | ||
| 2 | NCT05111249 (ClinicalTrials.gov) | December 8, 2021 | 15/10/2021 | A Dose Range Finding Study With Open-Label Extension to Evaluate the Safety of Oral LMI070/Branaplam in Early Manifest Huntington's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study With Open-Label Extension to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of LMI070/Branaplam Administered as Weekly Oral Doses in Participants With Early Manifest Huntington's Disease | Early Manifest Huntington Disease | Drug: Branaplam;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 25 Years | 75 Years | All | 75 | Phase 2 | Canada;France;Germany;Hungary;Spain |
| 3 | EUCTR2020-000105-92-IT (EUCTR) | 26/11/2021 | 20/09/2021 | A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington's Disease - - | 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] - Nervous System Diseases [C10] | Product Name: branaplam Product Code: [LMI070] INN or Proposed INN: BRANAPLAM Product Name: branaplam Product Code: [LMI070] INN or Proposed INN: BRANAPLAM Product Name: branaplam Product Code: [LMI070] INN or Proposed INN: BRANAPLAM Product Name: branaplam Product Code: [LMI070] INN or Proposed INN: BRANAPLAM Product Name: branaplam Product Code: [LMI070] INN or Proposed INN: BRANAPLAM | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | France;United States;Hungary;Canada;Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2020-000105-92-FR (EUCTR) | 18/11/2021 | 03/09/2021 | A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease | 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] - Nervous System Diseases [C10] | Product Name: branaplam Product Code: LMI070 INN or Proposed INN: BRANAPLAM | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy;United States;France;Hungary;Canada | ||
| 5 | EUCTR2020-000105-92-ES (EUCTR) | 02/11/2021 | 26/08/2021 | A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease | 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] - Nervous System Diseases [C10] | Product Name: branaplam Product Code: LMI070 INN or Proposed INN: BRANAPLAM | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | France;United States;Hungary;Canada;Belgium;Spain;Lithuania;Russian Federation;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2020-000105-92-HU (EUCTR) | 29/10/2021 | 24/08/2021 | A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease | 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] - Nervous System Diseases [C10] | Product Name: branaplam Product Code: LMI070 INN or Proposed INN: BRANAPLAM | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | France;United States;Hungary;Canada;Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2020-000105-92-DE (EUCTR) | 15/10/2021 | 18/08/2021 | A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease | 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] - Nervous System Diseases [C10] | Product Name: branaplam Product Code: LMI070 INN or Proposed INN: BRANAPLAM | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;France;Hungary;Canada;Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy |