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 | EUCTR2019-000374-39-DE (EUCTR) | 04/10/2019 | 28/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2019-000374-39-SE (EUCTR) | 26/09/2019 | 16/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2019-000374-39-PL (EUCTR) | 05/09/2019 | 22/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2019-000374-39-NL (EUCTR) | 27/08/2019 | 29/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden | ||
| 5 | EUCTR2019-000374-39-ES (EUCTR) | 07/08/2019 | 11/06/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2019-000374-39-GB (EUCTR) | 15/07/2019 | 09/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 7 | EUCTR2018-000137-13-BE (EUCTR) | 04/12/2018 | 13/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 8 | EUCTR2018-000137-13-NL (EUCTR) | 21/11/2018 | 18/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | France;United States;Canada;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden | ||
| 9 | EUCTR2018-000137-13-GB (EUCTR) | 19/11/2018 | 07/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden | ||
| 10 | EUCTR2018-000137-13-SE (EUCTR) | 22/10/2018 | 07/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 11 | EUCTR2018-000137-13-ES (EUCTR) | 19/10/2018 | 09/10/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | France;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 12 | EUCTR2018-000137-13-PL (EUCTR) | 18/10/2018 | 02/10/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 13 | EUCTR2018-000137-13-FR (EUCTR) | 05/10/2018 | 06/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden |