2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 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 | NCT03883581 (ClinicalTrials.gov) | July 25, 2019 | 12/3/2019 | Impact of Nuedexta on Bulbar Physiology and Function in ALS | Impact of Nuedexta on Bulbar Physiology and Function in ALS | Amyotrophic Lateral Sclerosis | Drug: dextromethorphan HBr and quinidine sulfate | University of Florida | Holy Cross Hospital, Florida;ALS Association | Completed | 18 Years | 90 Years | All | 28 | Phase 1/Phase 2 | United States |
| 2 | EUCTR2018-000668-28-GB (EUCTR) | 09/08/2018 | 25/06/2018 | A study to assess safety and acceptability of a treatment in patients with ALS | A Phase II pilot safety and tolerability study of ILB in patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) - The ALS Study | Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;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: ILB: 100mg/ml solution for injection and infusion INN or Proposed INN: Dextran Sodium Sulfur Salt 5, Mw 5 kDa. a type of Low Molecular Weight Dextran Sulfate (LMW-DS) Other descriptive name: ILB | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 3 | EUCTR2017-005065-47-SE (EUCTR) | 15/05/2018 | 19/03/2018 | A single-center, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis. | A single-centre, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILB Product Code: ILB INN or Proposed INN: ILB Other descriptive name: DEXTRAN SULFATE SODIUM | TikoMed AB | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Sweden | ||
| 4 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |