15. 封入体筋炎 Inclusion body myositis Clinical trials / Disease details
臨床試験数 : 42 / 薬物数 : 60 - (DrugBank : 16) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 123
| 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 | NCT04049097 (ClinicalTrials.gov) | May 20, 2019 | 1/4/2019 | Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension 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 | Inclusion Body Myositis | Drug: Arimoclomol | Orphazyme | University of Kansas Medical Center;University College, London | Completed | 45 Years | N/A | All | 121 | Phase 3 | United States;United Kingdom |
| 3 | 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 | ||
| 4 | NCT02753530 (ClinicalTrials.gov) | August 16, 2017 | 25/4/2016 | Study of Arimoclomol in Inclusion Body Myositis (IBM) | Phase II Study of Arimoclomol for the Treatment of Sporadic Inclusion Body Myositis (IBM) | Inclusion Body Myositis | Drug: Arimoclomol;Other: Placebo | Orphazyme | University of Kansas Medical Center;University College, London | Completed | 45 Years | N/A | All | 152 | Phase 2 | United States;United Kingdom |
| 5 | EUCTR2008-008208-42-GB (EUCTR) | 26/06/2009 | 29/05/2009 | A Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis - Arimoclomol for Inclusion Body Myositis | A Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis - Arimoclomol for Inclusion Body Myositis | The research project proposes to investigate Sporadic Inclusion Body Myositis (IBM). IBM is the commonest acquired disease of muscle affecting people aged 50 years and over. It is a progressive and debilitating disease which causes both muscle weakness and wasting, characteristically of the quadriceps and finger flexors. Over time it can lead to severe disability, falls and swallowing impairment. IBM is currently without a clinically proven, effective pharmacological treatment. MedDRA version: 9.1;Level: LLT;Classification code 10066407;Term: Inclusion body myositis | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: Arimoclomol Other descriptive name: Arimoclomol | UCL - The Joint UCLH/UCL Comprehensive Biomedical Research Unit | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 6 | NCT00769860 (ClinicalTrials.gov) | September 2008 | 8/10/2008 | Arimoclomol in Sporadic Inclusion Body Myositis | Safety and Tolerability Trial of Arimoclomol for Sporadic Inclusion Body Myositis | Inclusion Body Myositis | Drug: Arimoclomol;Other: Placebo | Richard Barohn, MD | NULL | Completed | 50 Years | N/A | All | 24 | Phase 2/Phase 3 | United States;United Kingdom |