EDASALONEXENT ( DrugBank: Edasalonexent )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
113筋ジストロフィー11

113. 筋ジストロフィー


臨床試験数 : 622 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04322357
(ClinicalTrials.gov)
July 30, 202024/3/2020Weekend Steroids and Exercise as Therapy for DMDImpact and Interplay of Corticosteroid Regimen and Exercise Training on DMD Muscle FunctionDuchenne Muscular Dystrophy (DMD)Drug: Prednisone;Behavioral: In-home Exercise Training;Drug: Prednisone with daily edasalonexent;Drug: Prednisone plus exerciseUniversity of FloridaU.S. Army Medical Research and Development Command;Catabasis PharmaceuticalsRecruiting5 Years8 YearsMale89Phase 2United States
2EUCTR2019-003563-22-IE
(EUCTR)
23/06/202021/01/2020A study to provide Edasalonexent to Pediatric Patients with Duchenne Muscular DystrophyAn Open-Label Extension Study of Edasalonexent in Pediatric Patients with Duchenne Muscular Dystrophy 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]
Product Name: Edasalonexent
Product Code: CAT-1004
INN or Proposed INN: EDASALONEXENT
Catabasis Pharmaceuticals Inc.NULLNot RecruitingFemale: no
Male: yes
140Phase 3United States;Canada;Ireland;Australia;Germany;United Kingdom;Sweden
3EUCTR2019-003563-22-GB
(EUCTR)
23/04/202013/01/2020A study to provide Edasalonexent to Pediatric Patients with Duchenne Muscular DystrophyAn Open-Label Extension Study of Edasalonexent in Pediatric Patients with Duchenne Muscular Dystrophy - An Open-Label Extension Study of Edasalonexent in DMD Patients 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]
Product Name: Edasalonexent
Product Code: CAT-1004
INN or Proposed INN: EDASALONEXENT
Catabasis Pharmaceuticals Inc.NULLNot RecruitingFemale: no
Male: yes
140Phase 3United States;Canada;Ireland;Australia;Germany;United Kingdom;Sweden
4EUCTR2019-003563-22-DE
(EUCTR)
16/04/202031/01/2020A study to provide Edasalonexent to Pediatric Patients with Duchenne Muscular DystrophyAn Open-Label Extension Study of Edasalonexent in Pediatric Patients with Duchenne Muscular Dystrophy 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]
Product Name: Edasalonexent
Product Code: CAT-1004
INN or Proposed INN: EDASALONEXENT
Catabasis Pharmaceuticals Inc.NULLNot RecruitingFemale: no
Male: yes
140Phase 3United States;Canada;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
5EUCTR2019-003563-22-SE
(EUCTR)
15/04/202003/02/2020A study to provide Edasalonexent to Pediatric Patients with Duchenne Muscular DystrophyAn Open-Label Extension Study of Edasalonexent in Pediatric Patients with Duchenne Muscular Dystrophy 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]
Product Name: Edasalonexent
Product Code: CAT-1004
INN or Proposed INN: EDASALONEXENT
Catabasis Pharmaceuticals Inc.NULLNot RecruitingFemale: no
Male: yes
140Phase 3United States;Canada;Ireland;Australia;Germany;United Kingdom;Sweden
6NCT03917719
(ClinicalTrials.gov)
March 14, 201912/4/2019An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular DystrophyAn Open-Label Extension Study of Edasalonexent in Pediatric Patients With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: EdasalonexentCatabasis PharmaceuticalsNULLTerminated4 Years12 YearsMale130Phase 3United States;Australia;Canada;Germany;Sweden;United Kingdom
7EUCTR2018-000464-29-DE
(EUCTR)
31/01/201924/09/2018A study to compare edasalonexent with placebo in patients with Duchenne Muscular dystrophyA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, GLOBAL PHASE 3 STUDY OF EDASALONEXENT IN PEDIATRIC PATIENTS WITH DUCHENNE MUSCULAR DYSTROPHY - POLARIS DMD 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]
Product Name: Edasalonexent
Product Code: CAT-1004
INN or Proposed INN: EDASALONEXENT
Product Name: Edasalonexent
Product Code: CAT-1004
INN or Proposed INN: EDASALONEXENT
Catabasis Pharmaceuticals, Inc.NULLNot RecruitingFemale: no
Male: yes
126Phase 3United States;Canada;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
8EUCTR2018-000464-29-IE
(EUCTR)
16/01/201902/10/2018A study to compare edasalonexent with placebo in pediatric patients with Duchenne Muscular dystrophy.A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, GLOBAL PHASE 3 STUDY OFEDASALONEXENT IN PEDIATRIC PATIENTS WITH DUCHENNE MUSCULAR DYSTROPHY - Phase 3 Study of Edasalonexent in Duchenne Muscular Dystrophy 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]
Product Name: Edasalonexent
Product Code: CAT-1004
INN or Proposed INN: Edasalonexent
Catabasis Pharmaceuticals, Inc.NULLNot RecruitingFemale: no
Male: yes
126Phase 3United States;Canada;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
9EUCTR2018-000464-29-SE
(EUCTR)
11/12/201824/09/2018A study to compare edasalonexent with placebo in patients with Duchenne Muscular dystrophy.A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, GLOBAL PHASE 3 STUDY OFEDASALONEXENT IN PEDIATRIC PATIENTS WITH DUCHENNE MUSCULAR DYSTROPHY - POLARIS DMD 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]
Product Name: Edasalonexent
Product Code: CAT-1004
INN or Proposed INN: Edasalonexent
Catabasis Pharmaceuticals, Inc.NULLNot RecruitingFemale: no
Male: yes
126Phase 3Canada;Ireland;Australia;Israel;Germany;United Kingdom;Sweden;United States
10NCT03703882
(ClinicalTrials.gov)
October 2, 20188/10/2018Phase III Study of Edasalonexent in Boys With Duchenne Muscular DystrophyA Randomized, Double-Blind, Placebo-Controlled, Global Phase 3 Study of Edasalonexent in Pediatric Patients With Duchenne Muscular DystrophyMuscular Dystrophy, DuchenneDrug: Edasalonexent;Drug: PlaceboCatabasis PharmaceuticalsNULLCompleted4 Years7 YearsMale131Phase 3United States;Australia;Canada;Germany;Ireland;Israel;Sweden;United Kingdom
11NCT02439216
(ClinicalTrials.gov)
April 201629/4/2015Phase 1/2 Study in Boys With Duchenne Muscular DystrophyA Phase 1/2 Study of Edasalonexent (CAT-1004) in Pediatric Patients With Duchenne Muscular DystrophyMuscular Dystrophy, DuchenneDrug: Edasalonexent;Drug: PlaceboCatabasis PharmaceuticalsNULLCompleted4 Years7 YearsMale31Phase 1/Phase 2United States