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 | NCT00694941 (ClinicalTrials.gov) | June 2008 | 6/6/2008 | A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS) | A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: ONO-2506PO | Ono Pharmaceutical Co. Ltd | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 2 | Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 2 | EUCTR2007-004723-37-DE (EUCTR) | 16/05/2008 | 29/01/2008 | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 2 | United Kingdom;Germany;Belgium;France | ||
| 3 | EUCTR2007-004723-37-GB (EUCTR) | 12/05/2008 | 15/02/2008 | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 2 | Germany;United Kingdom;Belgium;France | ||
| 4 | EUCTR2007-004723-37-BE (EUCTR) | 23/04/2008 | 31/01/2008 | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 2 | United Kingdom;Germany;Belgium;France | ||
| 5 | EUCTR2007-004723-37-FR (EUCTR) | 15/04/2008 | 06/02/2008 | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 2 | France;Belgium;Germany;United Kingdom | ||
| 6 | EUCTR2006-002660-26-NL (EUCTR) | 17/04/2007 | 03/01/2007 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 7 | EUCTR2006-002660-26-IT (EUCTR) | 01/02/2007 | 10/11/2006 | A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND | A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506 | ONO PHARMA UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 8 | EUCTR2006-002660-26-GB (EUCTR) | 08/01/2007 | 20/09/2006 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 9 | EUCTR2006-002660-26-DE (EUCTR) | 20/12/2006 | 19/01/2007 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria | |||
| 10 | EUCTR2006-002660-26-FR (EUCTR) | 12/12/2006 | 10/10/2006 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Phase 2 | France;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 11 | EUCTR2006-002660-26-BE (EUCTR) | 13/11/2006 | 28/09/2006 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 12 | EUCTR2006-002660-26-AT (EUCTR) | 13/11/2006 | 06/11/2006 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 13 | NCT00403104 (ClinicalTrials.gov) | November 2006 | 22/11/2006 | Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization | Amyotrophic Lateral Sclerosis (ALS) | Drug: ONO-2506PO | Ono Pharmaceutical Co. Ltd | NULL | Completed | 18 Years | 74 Years | Both | 420 | Phase 2 | Austria;Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 14 | EUCTR2004-002912-27-ES (EUCTR) | 04/10/2004 | 27/04/2005 | Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD). | Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD). | Amyotrophic lateral sclerosis MedDRA version: 7.0;Level: LL 1;Classification code 10002026 | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: (R)-(-)-2-Propyloctaroic acid | ONO PHARMA UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | Spain |