113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details


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

  
38 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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Inclusion_
gender
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PhaseCountries
1EUCTR2011-001266-17-CZ
(EUCTR)
20/12/201230/10/2012An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
INN or Proposed INN: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
200Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
2EUCTR2011-001266-17-DK
(EUCTR)
11/10/201211/10/2012An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 15.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
200Phase 3Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
3EUCTR2011-001266-17-BG
(EUCTR)
09/08/201229/05/2012An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 16.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
200Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
4EUCTR2011-001266-17-HU
(EUCTR)
02/08/201218/06/2012An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
INN or Proposed INN: NA
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
200Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
5EUCTR2010-020069-26-HU
(EUCTR)
25/05/201228/02/2012A phase III, randomized, double blind, placebo-controlledclinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - N/A A phase III, randomized, double blind, placebo-controlledclinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - N/A Duchenne muscular dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3Japan;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Norway;Netherlands;Germany
6EUCTR2011-001266-17-IT
(EUCTR)
20/03/201208/03/2012An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy
MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
INN or Proposed INN: NA
Other descriptive name: NA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: no
Male: yes
200Taiwan;Spain;Turkey;Russian Federation;Chile;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
7EUCTR2011-001266-17-ES
(EUCTR)
18/11/201103/10/2011An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy Duchenne Muscular Dystrophy
MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
INN or Proposed INN: GSK2402968
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: no
Male: yes
200Taiwan;Spain;Turkey;Israel;Russian Federation;Chile;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
8EUCTR2011-001266-17-DE
(EUCTR)
16/11/201131/08/2011An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 16.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
200Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
9EUCTR2011-001266-17-NL
(EUCTR)
03/11/201128/09/2011An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
200Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Germany;Netherlands;Norway;Japan;Korea, Republic of
10NCT01462292
(ClinicalTrials.gov)
October 26, 20113/10/2011A Clinical Study to Assess Two Doses of GSK2402968 in Subjects With Duchenne Muscular Dystrophy (DMD)An Exploratory Study to Assess Two Doses of GSK2402968 in the Treatment of Ambulant Boys With Duchenne Muscular DystrophyMuscular DystrophiesDrug: GSK2402968 3mg/kg/week;Drug: GSK2402968 6 mg/kg/week;Drug: Placebo to match GSK2402968 3 mg/kg/week;Drug: Placebo to match GSK2402968 6 mg/kg/weekGlaxoSmithKlineNULLCompleted5 YearsN/AMale51Phase 2United States
11EUCTR2011-001266-17-GB
(EUCTR)
03/10/201131/08/2011 An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot Recruiting Female: no
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noTaiwan;Spain;Turkey;Israel;Russian Federation;Chile;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
12NCT01480245
(ClinicalTrials.gov)
September 201123/11/2011Open Label Study of GSK2402968 in Subjects With Duchenne Muscular DystrophyAn Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular DystrophyMuscular DystrophiesDrug: GSK2402968GlaxoSmithKlineNULLTerminated5 YearsN/AMale233Phase 3Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Czech Republic;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Norway;Poland;Russian Federation;Spain;Taiwan;Turkey;United Kingdom
13EUCTR2011-001266-17-BE
(EUCTR)
08/08/201130/06/2011An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 16.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
200Phase 3Taiwan;Spain;Turkey;Israel;Russian Federation;Chile;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
14EUCTR2010-020069-26-DK
(EUCTR)
15/06/201118/05/2011A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy.A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A Duchenne muscular dystrophy
MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Germany;Norway;Japan
15EUCTR2010-020069-26-ES
(EUCTR)
11/04/201118/02/2011Ensayo clínico de fase III, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de GSK2402968 en sujetos con distrofia muscular de Duchenne.A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/AEnsayo clínico de fase III, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de GSK2402968 en sujetos con distrofia muscular de Duchenne.A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A Duchenne muscular dystrophy
MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
MedDRA version: 13;Term: Distrofia muscular de Duchenne
Product Code: GSK2402968GlaxoSmithKline.S.A.NULLNot RecruitingFemale: no
Male: yes
190Phase 3France;Hungary;Czech Republic;Poland;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy
16EUCTR2010-020069-26-PL
(EUCTR)
30/03/201103/01/2011A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy.A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A Duchenne muscular dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Germany;Norway;Japan
17EUCTR2010-020069-26-BE
(EUCTR)
15/03/201125/11/2010A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/AA phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A Duchenne muscular dystrophy
MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Netherlands;Germany;Italy
18EUCTR2010-020069-26-NL
(EUCTR)
02/03/201104/11/2010A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/AA phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A Duchenne muscular dystrophy
MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Germany;Netherlands;Italy
19EUCTR2010-020069-26-CZ
(EUCTR)
24/02/201113/01/2011A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy.A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A Duchenne muscular dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Germany;Norway;Japan
20NCT01254019
(ClinicalTrials.gov)
December 2, 201021/10/2010A Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular DystrophyA Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular DystrophyMuscular DystrophiesDrug: GSK2402968 6mg/kg/weekGlaxoSmithKlineNULLCompleted5 YearsN/AMale186Phase 3Argentina;Belgium;Brazil;Canada;Chile;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Norway;Poland;Russian Federation;Spain;Taiwan;Turkey;Czech Republic
21EUCTR2010-018412-32-ES
(EUCTR)
18/11/201001/12/2010Estudio clínico de fase II, doble ciego, explorador, de grupos paralelos y controlado con placebo para evaluar dos pautas posológicas de GSK2402968 para la eficacia, seguridad, tolerabilidad y farmacocinética en sujetos ambulatorios con distrofia muscular de DuchenneEstudio clínico de fase II, doble ciego, explorador, de grupos paralelos y controlado con placebo para evaluar dos pautas posológicas de GSK2402968 para la eficacia, seguridad, tolerabilidad y farmacocinética en sujetos ambulatorios con distrofia muscular de Duchenne Distrofia muscular de Duchenne
MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
54France;Spain;Netherlands;Germany;United Kingdom
22EUCTR2010-020069-26-IT
(EUCTR)
16/11/201021/12/2010A phase III, randomized, double blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - NDA phase III, randomized, double blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - ND Duchenne muscular dystrophy
MedDRA version: 9.1;Level: LLT;Classification code 10013801
Product Name: GSK2402968
Product Code: GSK2402968
INN or Proposed INN: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Netherlands;Germany;Italy
23EUCTR2010-020069-26-FR
(EUCTR)
16/09/201015/07/2010A randomized, double-blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in ambulant subjects with Duchenne muscular dystrophyA randomized, double-blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in ambulant subjects with Duchenne muscular dystrophy Duchenne muscular dystrophy
MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot Recruiting Female: no
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Italy
24EUCTR2010-018412-32-NL
(EUCTR)
13/09/201024/05/2010A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy - Duchenne Muscular Dystrophy
MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
54Phase 2United Kingdom;Germany;Netherlands;France;Spain
25NCT01153932
(ClinicalTrials.gov)
September 201029/6/2010Phase II Doubleblind Exploratory Study of GSK2402968 in Ambulant Subjects With Duchenne Muscular DystrophyA Phase II, Double Blind, Exploratory, Parallel-group, Placebocontrolled Clinical Study to Assess Two Dosing Regimens of GSK2402968 for Efficacy, Safety, Tolerability and Pharmacokinetics in Ambulant Subjects With Duchenne Muscular DystrophyMuscular DystrophiesDrug: GSK2402968;Drug: matched placeboGlaxoSmithKlineNULLCompleted5 YearsN/AMale53Phase 2Australia;Belgium;France;Germany;Israel;Netherlands;Spain;Turkey;United Kingdom
26EUCTR2010-018412-32-DE
(EUCTR)
05/08/201031/03/2010A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophyA phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy Duchenne Muscular Dystrophy
MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
54Phase 2France;Spain;Turkey;Australia;Israel;Netherlands;Germany;United Kingdom
27EUCTR2010-018412-32-FR
(EUCTR)
03/08/201003/08/2010A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophyA phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy Duchenne Muscular Dystrophy
MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot Recruiting Female: no
Male: yes
54 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Belgium;Netherlands;Germany;United Kingdom
28NCT01128855
(ClinicalTrials.gov)
July 12, 201020/5/2010A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study Assessing PK, Safety, Tolerability in Non-ambulant DMD SubjectsA Double-blind, Escalating Dose, Randomized, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Subcutaneous Injections of GSK2402968 in Non-ambulant Subjects With Duchenne Muscular DystrophyMuscular DystrophiesDrug: 3 mg/kg GSK2402968;Drug: 6 mg/kg GSK2402968;Drug: 9 mg/kg GSK2402968;Drug: 12 mg/kg GSK2402968;Other: PlaceboGlaxoSmithKlineNULLCompleted9 YearsN/AMale20Phase 1United States;France
29EUCTR2010-018412-32-GB
(EUCTR)
17/06/201016/04/2010A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophyA phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy Duchenne Muscular Dystrophy
MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
54Phase 2France;Spain;Turkey;Australia;Israel;Netherlands;Germany;United Kingdom
30EUCTR2010-018412-32-BE
(EUCTR)
15/06/201007/04/2010A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy Duchenne Muscular Dystrophy
MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
54Phase 2France;Spain;Belgium;Turkey;Australia;Israel;Netherlands;Germany;United Kingdom
31EUCTR2010-024566-22-Outside-EU/EEA
(EUCTR)
09/03/2012A clinical study to investigate the pharmacokinetics safety, and tolerability of a single dose of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy (GSK Study Number DMD114118)A double-blind, escalating dose, randomized, placebo-controlled study to assess the pharmacokinetics, safety and tolerability of single subcutaneous injections of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNAFemale: no
Male: yes
32United States
32EUCTR2010-024566-22-FR
(EUCTR)
22/02/2011A double-blind, escalating dose, randomized, placebo-controlled study to assess the pharmacokinetics, safety and tolerability of single subcutaneous injections of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy - N/AA double-blind, escalating dose, randomized, placebo-controlled study to assess the pharmacokinetics, safety and tolerability of single subcutaneous injections of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNAFemale: no
Male: yes
32Phase 1France
33EUCTR2011-001266-17-Outside-EU/EEA
(EUCTR)
09/03/2012An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNAFemale: no
Male: yes
32NULL
34EUCTR2010-018412-32-Outside-EU/EEA
(EUCTR)
09/03/2012A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophyA phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy - Duchenne Muscular Dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNAFemale: no
Male: yes
54Phase 2Australia;Israel;Turkey
35EUCTR2011-001266-17-FR
(EUCTR)
05/07/2011An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular DystrophyAn open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A Duchenne Muscular Dystrophy
MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: GSK2402968
Product Code: GSK2402968
GlaxoSmithKline Research and Development LTDNULLNAFemale: no
Male: yes
200Phase 3Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of
36EUCTR2010-020069-26-NO
(EUCTR)
27/04/2011A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/AA phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A Duchenne muscular dystrophy
MedDRA version: 13.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Italy
37EUCTR2010-020069-26-DE
(EUCTR)
22/06/2010A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy.A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A Duchenne muscular dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNot RecruitingFemale: no
Male: yes
180Phase 3Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Germany;Norway;Japan
38EUCTR2010-020069-26-Outside-EU/EEA
(EUCTR)
09/03/2012A phase III, randomized, double blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy.A phase III, randomized, double blind, placebo-controlledclinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - N/A Duchenne muscular dystrophy
MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Code: GSK2402968GlaxoSmithKline Research and Development LTDNULLNAFemale: no
Male: yes
180Phase 3Argentina;Belgium;Brazil;Canada;Chile;Czech Republic;Denmark;France;Germany;Italy;Japan;Korea, Democratic People's Republic of;Netherlands;Norway;Poland;Russian Federation;Spain;Taiwan