20. 副腎白質ジストロフィー Adrenoleukodystrophy Clinical trials / Disease details
臨床試験数 : 61 / 薬物数 : 90 - (DrugBank : 31) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
| 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 | EUCTR2019-000654-59-FR (EUCTR) | 31/03/2020 | 21/07/2020 | A study to evaluate the effects of a new drug called MIN-102 on diseaseprogression in boys with cerebral X-linked adrenoleukodystrophy (cALD) | An open-label, multicenter study in male pediatric patients with cerebral X-linked Adrenoleukodystrophy (cALD) to assess the effect of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT) | Cerebral X-linked Adrenoleukodystrophy (cALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2- pyridinyl)ethoxy]benzyl]-2,4- thiazolidinedione hydrochloride INN or Proposed INN: Leriglitazone Other descriptive name: 5-[[4-[2-[5-(1-HYDROXYETHYL)-2-PYRIDINYL]ETHOXY]PHENYL]METHYL]-2,4-THIAZOLIDINEDIONE HYDROCHLORIDE | Minoryx Therapeutics S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 13 | Phase 2 | United States;France;Spain;Germany | ||
| 2 | NCT04528706 (ClinicalTrials.gov) | September 13, 2019 | 31/7/2020 | A Clinical Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT) | An Open-label, Multicenter Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT) | Cerebral Adrenoleukodystrophy | Drug: MIN-102 | Minoryx Therapeutics, S.L. | NULL | Recruiting | 2 Years | 12 Years | Male | 13 | Phase 2 | Argentina;France;Germany;Spain |
| 3 | EUCTR2019-000654-59-DE (EUCTR) | 13/08/2019 | 19/07/2019 | A study to evaluate the effects of a new drug called MIN-102 on diseaseprogression in boys with cerebral X-linked adrenoleukodystrophy (cALD) | An open-label, multicenter study in male pediatric patients with cerebral X-linked Adrenoleukodystrophy (cALD) to assess the effect of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT) | Cerebral X-linked Adrenoleukodystrophy (cALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2- pyridinyl)ethoxy]benzyl]-2,4- thiazolidinedione hydrochloride INN or Proposed INN: Leriglitazone Other descriptive name: 5-[[4-[2-[5-(1-HYDROXYETHYL)-2-PYRIDINYL]ETHOXY]PHENYL]METHYL]-2,4-THIAZOLIDINEDIONE HYDROCHLORIDE | Minoryx Therapeutics S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 13 | Phase 2 | France;United States;Argentina;Spain;Germany | ||
| 4 | EUCTR2019-000654-59-ES (EUCTR) | 25/06/2019 | 30/04/2019 | A study to evaluate the effects of a new drug called MIN-102 on the progression of brain lesions in boys with cerebral X-linked adrenoleukodystrophy (cALD) | An exploratory, open-label, multicenter study in male pediatric patients with cerebral X-linked Adrenoleukodystrophie (cALD) to assess the effect of MIN-102 treatment on the progression of cerebral lesions. | Cerebral X-linked Adrenoleukodystrophy (cALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2- pyridinyl)ethoxy]benzyl]-2,4- thiazolidinedione hydrochloride INN or Proposed INN: Leriglitazone Other descriptive name: 5-[[4-[2-[5-(1-HYDROXYETHYL)-2-PYRIDINYL]ETHOXY]PHENYL]METHYL]-2,4-THIAZOLIDINEDIONE HYDROCHLORIDE | Minoryx Therapeutics S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Germany | ||
| 5 | EUCTR2017-000748-16-PL (EUCTR) | 12/06/2018 | 02/05/2018 | Study to evaluate effect of MIN-102 compared to Placebo after 96 weeks of randomized, double-blind Treatment followed by open-label extension study to evaluate effect of long term treatment with MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY - ADVANCE | ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride Product Code: MIN-102 INN or Proposed INN: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride | Minoryx Therapeutics S.L. | NULL | Not Recruiting | Female: no Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Spain;Poland;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2017-000748-16-DE (EUCTR) | 02/01/2018 | 22/06/2017 | Study to evaluate effect of MIN-102 compared to Placebo after 96 weeks of randomized, double-blind Treatment followed by open-label extension study to evaluate effect of long term treatment with MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY - ADVANCE | ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride Product Code: MIN-102 INN or Proposed INN: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride | Minoryx Therapeutics S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 105 | Phase 2;Phase 3 | France;United States;Hungary;Poland;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 7 | NCT03231878 (ClinicalTrials.gov) | December 8, 2017 | 24/7/2017 | A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients. | A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter Study With Open-label Treatment Extension to Assess the Effect of MIN-102 (IMP) on the Progression of Adrenomyeloneuropathy in Male Patients With X-linked Adrenoleukodystrophy | Adrenoleukodystrophy | Drug: MIN-102;Drug: Placebos | Minoryx Therapeutics, S.L. | NULL | Active, not recruiting | 18 Years | 65 Years | Male | 105 | Phase 2/Phase 3 | United States;France;Germany;Hungary;Italy;Netherlands;Spain;United Kingdom |
| 8 | EUCTR2017-000748-16-NL (EUCTR) | 23/11/2017 | 10/07/2017 | Study to evaluate effect of MIN-102 compared to Placebo after 96 weeks of randomized, double-blind Treatment followed by open-label extension study to evaluate effect of long term treatment with MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY - ADVANCE | ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride Product Code: MIN-102 INN or Proposed INN: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride | Minoryx Therapeutics S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Poland;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 9 | EUCTR2017-000748-16-GB (EUCTR) | 14/09/2017 | 19/06/2017 | Study to evaluate effect of MIN-102 compared to Placebo after 96 weeks of randomized, double-blind Treatment followed by open-label extension study to evaluate effect of long term treatment with MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY - ADVANCE | ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride Product Code: MIN-102 INN or Proposed INN: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride | Minoryx Therapeutics S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 105 | Phase 2;Phase 3 | France;United States;Hungary;Poland;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2017-000748-16-HU (EUCTR) | 04/09/2017 | 30/06/2017 | Study to evaluate effect of MIN-102 compared to Placebo after 96 weeks of randomized, double-blind Treatment followed by open-label extension study to evaluate effect of long term treatment with MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY - ADVANCE | ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride Product Code: MIN-102 INN or Proposed INN: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride | Minoryx Therapeutics S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 105 | Phase 2;Phase 3 | France;United States;Hungary;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 11 | EUCTR2017-000748-16-ES (EUCTR) | 25/08/2017 | 04/07/2017 | Study to evaluate effect of MIN-102 compared to Placebo after 96 weeks of randomized, double-blind Treatment followed by open-label extension study to evaluate effect of long term treatment with MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY - ADVANCE | ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride Product Code: MIN-102 INN or Proposed INN: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride | Minoryx Therapeutics S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 105 | Phase 2;Phase 3 | France;United States;Hungary;Spain;Netherlands;Germany;Italy;United Kingdom |