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 | EUCTR2004-002855-15-DE (EUCTR) | 29/12/2004 | 02/12/2004 | A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. | A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis | Product Code: TCH346 INN or Proposed INN: not established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 480 | United Kingdom;Germany;Italy | |||
| 2 | EUCTR2004-002855-15-GB (EUCTR) | 21/12/2004 | 04/05/2005 | A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. | A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis | Product Code: TCH346 INN or Proposed INN: not established INN or Proposed INN: not established INN or Proposed INN: not established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 480 | Germany;Italy;United Kingdom | |||
| 3 | EUCTR2004-002855-15-IT (EUCTR) | 09/11/2004 | 08/01/2007 | A long term extension to a randomised, double-blind, placebo-controlled, stratified, paralle-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 1.0, 2.5, 7.5 and 15 mg administered once daily in patients with Amyotrophic Lateral Sclerosis | A long term extension to a randomised, double-blind, placebo-controlled, stratified, paralle-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 1.0, 2.5, 7.5 and 15 mg administered once daily in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Code: TCH346 Product Code: TCH346 Product Code: TCH346 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 476 | United Kingdom;Germany;Italy | |||
| 4 | NCT00230074 (ClinicalTrials.gov) | November 2004 | 28/9/2005 | A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS) | A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS) | Amyotrophic Lateral Sclerosis | Drug: TCH346 | Novartis | NULL | Completed | 21 Years | 80 Years | Both | 350 | Phase 2 | United States |
| 5 | NCT00072709 (ClinicalTrials.gov) | September 2003 | 7/11/2003 | Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: TCH346 | Novartis Pharmaceuticals | NULL | Completed | 21 Years | 80 Years | Both | 551 | Phase 2 | United States;Belgium;Canada;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 6 | NCT00036413 (ClinicalTrials.gov) | January 2002 | 9/5/2002 | A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis | A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis | Drug: TCH346 | Novartis Pharmaceuticals | NULL | Completed | 40 Years | 75 Years | Both | 44 | Phase 2 | United States |