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 | EUCTR2020-005971-11-DE (EUCTR) | 22/12/2021 | 11/06/2021 | A Phase 2a study to evaluate, safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with amyotrophic lateral sclerosis (ALS) | A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with familial amyotrophic lateral sclerosis (fALS) and sporadic amyotrophic lateral sclerosis (sALS) | 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 Name: AP-101 Product Code: AP-101 INN or Proposed INN: Not yet available Other descriptive name: Anti-(misfolded human superoxide dismutase 1) human IgG1m3 monoclonal antibody | AL-S Pharma, AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | United States;Canada;Germany;Sweden;Korea, Republic of |