127. 前頭側頭葉変性症 Frontotemporal lobar degeneration Clinical trials / Disease details
臨床試験数 : 90 / 薬物数 : 87 - (DrugBank : 30) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 88
| 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 | NCT05683860 (ClinicalTrials.gov) | December 14, 2022 | 4/1/2023 | Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) | A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) | ALS;FTD | Drug: WVE-004 | Wave Life Sciences Ltd. | NULL | Enrolling by invitation | N/A | N/A | All | 42 | Phase 1/Phase 2 | Netherlands |
| 2 | EUCTR2020-005193-94-SE (EUCTR) | 26/01/2022 | 12/10/2021 | Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | Amyotrophic Lateral Sclerosis and Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: WVE-004 INN or Proposed INN: not yet assigned Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts | Wave Life Sciences UK Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 1;Phase 2 | United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden | ||
| 3 | EUCTR2020-005193-94-BE (EUCTR) | 26/01/2022 | 15/10/2021 | Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | Amyotrophic Lateral Sclerosis and Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: WVE-004 INN or Proposed INN: not yet assigned Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts | Wave Life Sciences UK Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 1;Phase 2 | United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden | ||
| 4 | NCT04931862 (ClinicalTrials.gov) | June 28, 2021 | 11/6/2021 | Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | ALS;FTD | Drug: WVE-004;Drug: Placebo | Wave Life Sciences Ltd. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 35 | Phase 1/Phase 2 | Australia;Belgium;Canada;Ireland;Netherlands;New Zealand;Sweden;United Kingdom |