113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 646 / 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
| 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 | EUCTR2017-004554-42-FR (EUCTR) | 26/03/2020 | 17/08/2018 | The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease. | Tamoxifen in Duchenne muscular dystrophy - TAMDMDA multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Tamoxifen 20mg Hexal® Filmtabletten INN or Proposed INN: Tamoxifen Other descriptive name: TAMOXIFEN CITRATE | University of Basel Children's Hospital, Division of Neuropediatrics | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 100 | Phase 3 | France;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland | ||
| 2 | EUCTR2017-004554-42-GB (EUCTR) | 29/01/2019 | 03/08/2018 | The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease. | Tamoxifen in Duchenne muscular dystrophy - TAMDMDA multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trialTamoxifen in Duchenne muscular dystrophy: A 48-week open labelextension of a multicentre, randomised, double-blind, placebo-controlled,phase 3 safety and efficacy trial | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Tamoxifen 20mg Hexal® Filmtabletten INN or Proposed INN: Tamoxifen Other descriptive name: TAMOXIFEN CITRATE | University of Basel Children's Hospital, Division of Neuropediatrics | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 100 | Phase 3 | France;Belgium;Spain;Netherlands;Germany;Switzerland;United Kingdom | ||
| 3 | EUCTR2017-004554-42-ES (EUCTR) | 22/01/2019 | 17/09/2018 | The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease. | Tamoxifen in Duchenne muscular dystrophy - TAMDMD A multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: TAMOX INN or Proposed INN: Tamoxifen Other descriptive name: TAMOXIFEN CITRATE | University of Basel Children's Hospital, Division of Neuropediatrics | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland | ||
| 4 | EUCTR2017-004554-42-NL (EUCTR) | 16/01/2019 | 02/10/2018 | The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease. | Tamoxifen in Duchenne muscular dystrophy - TAMDMDA multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: TAMOXIFEN INN or Proposed INN: Tamoxifen Other descriptive name: TAMOXIFEN CITRATE | University of Basel Children's Hospital, Division of Neuropediatrics | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 100 | Phase 3 | France;Belgium;Spain;Turkey;Germany;Netherlands;United Kingdom;Switzerland | ||
| 5 | NCT03354039 (ClinicalTrials.gov) | June 12, 2018 | 10/10/2017 | Tamoxifen in Duchenne Muscular Dystrophy | Tamoxifen in Duchenne Muscular Dystrophy: A Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Safety and Efficacy 48-week Trial | Duchenne Muscular Dystrophy | Drug: Tamoxifen;Drug: Matching placebo | University Hospital, Basel, Switzerland | NULL | Completed | 78 Months | 16 Years | Male | 93 | Phase 3 | France;Germany;Netherlands;Spain;Switzerland;United Kingdom |
| 6 | EUCTR2017-004554-42-BE (EUCTR) | 30/04/2019 | The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease. | Tamoxifen in Duchenne muscular dystrophy:A multicenter, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trialTamoxifen in Duchenne muscular dystrophy: A 48-week open label extension of a multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy trial | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Tamoxifen 20mg Hexal® Filmtabletten INN or Proposed INN: Tamoxifen Other descriptive name: TAMOXIFEN CITRATE | University of Basel Children's Hospital, Division of Neuropediatrics | NULL | NA | Female: no Male: yes | 100 | Phase 3 | France;Spain;Belgium;Turkey;Netherlands;Germany;United Kingdom;Switzerland | |||
| 7 | EUCTR2017-004554-42-DE (EUCTR) | 27/07/2018 | The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease. | Tamoxifen in Duchenne muscular dystrophy: A multicenter, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial Tamoxifen in Duchenne muscular dystrophy: A 48-week open label extension of a multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy trial | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Tamoxifen 20mg Hexal® Filmtabletten INN or Proposed INN: Tamoxifen Other descriptive name: TAMOXIFEN CITRATE | University of Basel Children's Hospital, Division of Neuropediatrics | NULL | NA | Female: no Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland |