2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| 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 | NCT04948645 (ClinicalTrials.gov) | September 22, 2021 | 23/6/2021 | A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of ABBV-CLS-7262 in Subjects With Amyotrophic Lateral Sclerosis Followed by an Active Treatment Extension | ALS;Amyotrophic Lateral Sclerosis | Drug: ABBV-CLS-7262;Drug: Placebo | Calico Life Sciences LLC | AbbVie | Active, not recruiting | 18 Years | 80 Years | All | 31 | Phase 1 | United States;Canada |
| 2 | NCT04066244 (ClinicalTrials.gov) | December 30, 2019 | 21/8/2019 | Study of Safety and of the Mechanism of BLZ945 in ALS Patients | An Open-label, Adaptive Design Study in Patients With Amyotrophic Lateral Sclerosis (ALS) to Characterize Safety, Tolerability and Brain Microglia Response, as Measured by TSPO Binding, Following Multiple Doses of BLZ945 Using Positron Emission Tomography (PET) With the Radioligand [11C]-PBR28 | Amyotrophic Lateral Sclerosis | Drug: BLZ945 | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 56 | Phase 2 | United States;Finland;Sweden |
| 3 | EUCTR2019-000826-22-FI (EUCTR) | 05/11/2019 | 18/09/2019 | Study of safety and of the mechanism of BLZ945 in amyotrophic lateral sclerosis (ALS) patients. | An open-label, adaptive design study in patients with amyotrophic lateral sclerosis (ALS) to characterize safety, tolerability and brain microglia response, as measured by TSPO binding, following multiple doses of BLZ945 using positron emission tomography (PET) with the radioligand [11C]-PBR28 | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BLZ945 INN or Proposed INN: Not yet defined Other descriptive name: BLZ945 Product Code: BLZ945 INN or Proposed INN: Not yet defined Other descriptive name: BLZ945 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;Finland;Sweden | ||
| 4 | EUCTR2019-000826-22-SE (EUCTR) | 17/09/2019 | 02/08/2019 | Study of safety and of the mechanism of BLZ945 in amyotrophic lateral sclerosis (ALS) patients. | An open-label, adaptive design study in patients with amyotrophic lateral sclerosis (ALS) to characterize safety, tolerability and brain microglia response, as measured by TSPO binding, following multiple doses of BLZ945 using positron emission tomography (PET) with the radioligand [11C]-PBR28 | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BLZ945 INN or Proposed INN: Not yet defined Other descriptive name: BLZ945 Product Code: BLZ945 INN or Proposed INN: Not yet defined Other descriptive name: BLZ945 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;Finland;Sweden | ||
| 5 | NCT03520517 (ClinicalTrials.gov) | February 2, 2018 | 17/4/2018 | Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS | Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of BHV-0223 in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis;ALS;Lou Gehrig Disease;Lou Gehrig's Disease;Lou-Gehrigs Disease;Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Drug: BHV-0223 | Biohaven Pharmaceuticals, Inc. | Cognitive Research Corporation | Completed | 18 Years | N/A | All | 22 | Phase 1 | United States |
| 6 | NCT02870634 (ClinicalTrials.gov) | November 16, 2016 | 10/8/2016 | Phase 1 Dose Escalation and PK Study of Cu(II)ATSM in ALS/MND | A Phase 1 Single and Multiple Dose Escalation and Pharmacokinetic Study of Cu(II)ATSM Administered Orally to Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: Cu(II)ATSM | Collaborative Medicinal Development Pty Limited | NULL | Completed | 18 Years | 75 Years | All | 50 | Phase 1 | Australia |
| 7 | NCT01424163 (ClinicalTrials.gov) | August 2011 | 28/7/2011 | Dexpramipexole Japanese PK Study | A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects | Amyotrophic Lateral Sclerosis | Drug: Single dose reduced;Drug: Single dose standard;Drug: Multiple Dose | Knopp Biosciences | Biogen | Completed | 18 Years | 60 Years | All | 57 | Phase 1 | United Kingdom |
| 8 | NCT01378676 (ClinicalTrials.gov) | June 2011 | 20/6/2011 | A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Placebo (Part A);Drug: CK-2017357 (Part A);Drug: Riluzole 50 MG (Part B);Drug: Placebo (Part B);Drug: CK-2017357 (Part B) | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 49 | Phase 2 | United States |