Brx-345 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 9 |
| 15 | 封入体筋炎 | 2 |
| 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 | 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 | ||
| 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 | Authorised-recruitment may be ongoing or finished | 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 | Authorised-recruitment may be ongoing or finished | 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: 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;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 | ||
| 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 |
| 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-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 | United States;France;Canada;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden | ||
| 8 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 9 | 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 |
| 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 | EUCTR2019-000749-11-GB (EUCTR) | 09/10/2019 | 20/06/2019 | An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial | An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial. | Sporadic Inclusion Body Myositis (sIBM) MedDRA version: 21.1;Level: LLT;Classification code 10075052;Term: Sporadic inclusion body myositis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL Other descriptive name: Arimoclomol citrate | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;United Kingdom | ||
| 2 | EUCTR2017-004903-33-GB (EUCTR) | 18/06/2018 | 05/04/2018 | Study of Arimoclomol in patients with Inclusion Body Myositis (IBM) | Phase 2/3 Study of Arimoclomol in Inclusion Body Myositis (IBM)A Randomized, Double-blind, Placebo-Controlled Trial | Sporadic Inclusion Body Myositis (sIBM) MedDRA version: 21.1;Level: LLT;Classification code 10075052;Term: Sporadic inclusion body myositis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL Other descriptive name: Arimoclomol citrate | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2;Phase 3 | United States;United Kingdom |