EMFLAZA® (DEFLAZACORT) ( DrugBank: Deflazacort )


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4

113. 筋ジストロフィー


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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2018-004740-36-DK
(EUCTR)
29/10/201925/06/2019A clinical study to evaluate how safe and effective the drug Deflazacort (EMFLAZA®) compared to placebo is in subjects with Limb-Girdle Muscular Dystrophy Type 2IA MULTICENTER RANDOMIZED PLACEBO-CONTROLLED PHASE 3 STUDY ON THE SAFETY AND EFFICACY OF DEFLAZACORT (EMFLAZA®) IN SUBJECTS WITH LIMB-GIRDLE MUSCULAR DYSTROPHY 2I (LGMD2I Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)
MedDRA version: 20.0;Level: PT;Classification code 10028356;Term: Muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;France;Canada;Denmark;Russian Federation;Norway;Germany;Sweden
2EUCTR2018-004740-36-DE
(EUCTR)
14/10/201929/04/2019A clinical study to evaluate how safe and effective the drug Deflazacort (EMFLAZA®) compared to placebo is in subjects with Limb-Girdle Muscular Dystrophy Type 2IA MULTICENTER RANDOMIZED PLACEBO-CONTROLLED PHASE 3 STUDY ON THE SAFETY AND EFFICACY OF DEFLAZACORT (EMFLAZA®) IN SUBJECTS WITH LIMB-GIRDLE MUSCULAR DYSTROPHY 2I (LGMD2I Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)
MedDRA version: 20.0;Level: PT;Classification code 10028356;Term: Muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Canada;Denmark;Russian Federation;Norway;Germany;Sweden
3EUCTR2018-004740-36-FR
(EUCTR)
19/08/201904/06/2019A clinical study to evaluate how safe and effective the drug Deflazacort (EMFLAZA®) compared to placebo is in subjects with Limb-Girdle Muscular Dystrophy Type 2IA MULTICENTER RANDOMIZED PLACEBO-CONTROLLED PHASE 3 STUDY ON THE SAFETY AND EFFICACY OF DEFLAZACORT (EMFLAZA®) IN SUBJECTS WITH LIMB-GIRDLE MUSCULAR DYSTROPHY 2I (LGMD2I Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)
MedDRA version: 20.0;Level: PT;Classification code 10028356;Term: Muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
Trade Name: EMFLAZA® (DEFLAZACORT)
Product Name: EMFLAZA® (deflazacort)
Product Code: EMFLAZA® (deflazacort)
INN or Proposed INN: Deflazacort
Other descriptive name: DEFLAZACORT
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;France;Canada;Denmark;Norway;Germany;Sweden
4NCT03642145
(ClinicalTrials.gov)
October 31, 201810/7/2018A Study of Deflazacort (Emflaza®) in Participants With Duchenne Muscular Dystrophy (DMD)A 52-Week Phase 3B Randomized Open-Label Study Evaluating the Safety and Pharmacokinetics of Emflaza® (Deflazacort) Compared to a Comparable Natural History Control Group in Males Aged =2 to <5 Years With Duchenne Muscular Dystrophy (DMD) Followed by a 52-Week Extension PeriodDuchenne Muscular DystrophyDrug: DeflazacortPTC TherapeuticsNULLWithdrawn2 Years4 YearsMale0Phase 3United States