Idebenone ( DrugBank: Idebenone )


6 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病2
8ハンチントン病1
13多発性硬化症/視神経脊髄炎2
18脊髄小脳変性症(多系統萎縮症を除く。)3
113筋ジストロフィー37
302レーベル遺伝性視神経症1

6. パーキンソン病


臨床試験数 : 2,298 薬物数 : 2,218 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04152655
(ClinicalTrials.gov)
January 1, 20207/10/2019A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson DiseaseA Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)REM Sleep Behavior Disorder;Parkinson DiseaseDrug: Idebenone;Drug: Placebo oral tabletSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityPeking Union Medical College Hospital;Beijing Hospital;Beijing Tiantan Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Jiangsu Province Nanjing Brain Hospital;The First Affiliated Hospital of Anhui Medical University;Huashan Hospital;Tongji Hospital;Second Affiliated Hospital of Soochow University;Guizhou Medical University;The First Affiliated Hospital of Guangzhou Medical University;Peking University Shenzhen Hospital;West China Hospital;Wuhan Union Hospital, China;Sir Run Run Shaw Hospital;The Affiliated Hospital of Hangzhou Normal University;The First Affiliated Hospital of Dalian Medical University;Qilu Hospital of Shandong UniversityRecruiting18 YearsN/AAll180Phase 2/Phase 3China
2NCT03727295
(ClinicalTrials.gov)
January 1, 201930/10/2018Idebenone Treatment of Early Parkinson's DiseasesymptomsA Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor SymptomsOxidative Stress is an Important Cause of Parkinson's DiseaseDrug: Idebenone/placeboSecond Affiliated Hospital of Soochow UniversityQilu Pharmaceutical Co., Ltd.Not yet recruiting30 Years80 YearsAll180Phase 4NULL

8. ハンチントン病


臨床試験数 : 229 薬物数 : 197 - (DrugBank : 60) / 標的遺伝子数 : 84 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04071639
(ClinicalTrials.gov)
March 12, 202026/8/2019Symptomatic Therapy for Patients With Huntington's DiseaseNon-randomized Control Clinical Trial to Evaluate the Efficacy and Safety of Symptomatic Drug Therapy for Mild to Moderate Huntington's Disease PatientsHuntington DiseaseDrug: Haloperidol 2Mg Tab;Drug: Risperidone 1Mg Tab;Drug: Zoloft 50Mg Tablet;Drug: Idebenone;Drug: Deutetrabenazine Oral Tablet [Austedo]Second Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruitingN/AN/AAll60Phase 1China

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,380 - (DrugBank : 407) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01854359
(ClinicalTrials.gov)
May 11, 201311/5/2013Idebenone for Primary Progressive Multiple SclerosisOpen Label Extension Trial of Idebenone for Primary Progressive Multiple SclerosisMultiple Sclerosis;Primary Progressive Multiple SclerosisDrug: IdebenoneNational Institute of Allergy and Infectious Diseases (NIAID)NULLUnknown status18 YearsN/AAll61Phase 1/Phase 2United States
2NCT00950248
(ClinicalTrials.gov)
November 1, 200930/7/2009Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)Double Blind Placebo-Controlled Phase I/II Clinical Trial of Idebenone in Patients With Primary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisDrug: Idebenone;Other: placeboNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years65 YearsAll85Phase 1/Phase 2United States

18. 脊髄小脳変性症(多系統萎縮症を除く。)


臨床試験数 : 71 薬物数 : 101 - (DrugBank : 30) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 65
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00229632
(ClinicalTrials.gov)
September 27, 200529/9/2005Idebenone to Treat Friedreich's AtaxiaA Six Month Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Determine the Safety and Efficacy of Idebenone Administered to Patients With Friedreich's AtaxiaFriedreich AtaxiaDrug: IdebenoneNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted9 Years17 YearsAll51Phase 2United States
2NCT00078481
(ClinicalTrials.gov)
February 200427/2/2004Phase 1 Trial of Idebenone to Treat Patients With Friedreich's AtaxiaPhase 1B Clinical Trial to Establish the Safety and Tolerability of a Multiple-Dose Regimen of Idebenone Administered to Patients With Friedreich's AtaxiaFriedreich AtaxiaDrug: IdebenoneNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth16Phase 1United States
3NCT00015808
(ClinicalTrials.gov)
May 20016/5/2001Safety Study of Idebenone to Treat Friedreich's AtaxiaPhase I Clinical Trial to Establish the Maximum Tolerated Dose of Idebenone in Children, Adolescents, and Adults With Friedreich's AtaxiaFriedreich AtaxiaDrug: IdebenoneNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth100Phase 1United States

113. 筋ジストロフィー


臨床試験数 : 622 薬物数 : 494 - (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
1EUCTR2016-000602-10-BG
(EUCTR)
10/03/202007/01/2020A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
2EUCTR2017-004279-30-NL
(EUCTR)
23/01/202016/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden
3EUCTR2017-004279-30-AT
(EUCTR)
15/02/201904/01/2019A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
4EUCTR2017-004279-30-ES
(EUCTR)
21/12/201816/11/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Belgium;Spain;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
5EUCTR2016-000602-10-HU
(EUCTR)
18/12/201805/11/2018A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
6EUCTR2017-004279-30-GB
(EUCTR)
26/10/201809/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden
7EUCTR2017-004279-30-IT
(EUCTR)
29/08/201822/01/2021A clinical study to assess the long-term safety and efficacy of idebenonetreatment in patients with Duchenne Muscular Dystrophy (DMD) whocompleted the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safetyand Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy(DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
Product Code: [Idebenone]
INN or Proposed INN: IDEBENONE
SANTHERA PHARMACEUTICALSNULLNot RecruitingFemale: no
Male: yes
266Phase 3France;United States;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
8NCT03603288
(ClinicalTrials.gov)
July 4, 201831/5/2018Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS StudyDuchenne Muscular DystrophyDrug: idebenone 150 mg film-coated tabletsSanthera PharmaceuticalsNULLTerminated11 YearsN/AMale161Phase 3United States;Austria;Belgium;France;Germany;Italy;Spain;Switzerland;United Kingdom
9EUCTR2017-004279-30-BE
(EUCTR)
14/06/201804/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
10EUCTR2016-000602-10-NL
(EUCTR)
26/04/201720/09/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Netherlands;Germany;Sweden
11EUCTR2016-000602-10-GB
(EUCTR)
28/12/201623/09/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Netherlands;Germany;Sweden
12EUCTR2016-000602-10-AT
(EUCTR)
21/12/201601/12/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
13EUCTR2016-000602-10-ES
(EUCTR)
20/12/201618/11/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
MedDRA version: 19.0;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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
14EUCTR2016-000602-10-FR
(EUCTR)
25/11/201612/01/2017A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
MedDRA version: 19.1;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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
15EUCTR2016-000602-10-DE
(EUCTR)
17/11/201630/05/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
16EUCTR2016-000602-10-IT
(EUCTR)
20/10/201606/02/2018A clinical study to assess how effective and safe is idebenone treatment inpatients with Duchenne Muscular Dystrophy (DMD) who are currentlyreceiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Studyassessing the Efficacy, Safety and Tolerability of Idebenone inPatients with Duchenne Muscular Dystrophy Receiving GlucocorticoidSteroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: RAXONE - 150 MG- COMPRESSE RIVESTITE CON FILM- USO ORALE- FLACONE (HDPE)- 180 COMPRESSE
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
SANTHERA PHARMACEUTICALSNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
266Phase 3France;United States;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
17EUCTR2016-000602-10-BE
(EUCTR)
02/09/201619/07/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
18NCT02814019
(ClinicalTrials.gov)
September 201617/6/2016A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid SteroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid SteroidsDuchenne Muscular Dystrophy (DMD)Drug: Idebenone 150 mg film-coated tablets;Drug: placeboSanthera PharmaceuticalsNULLTerminated10 YearsN/AMale255Phase 3United States;Austria;Belgium;Bulgaria;France;Germany;Hungary;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
19NCT03433807
(ClinicalTrials.gov)
January 29, 20138/2/2018Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)Expanded Access Protocol (EAP) of Idebenone in Patients With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: IdebenoneSanthera PharmaceuticalsNULLTemporarily not available8 YearsN/AAllUnited States
20EUCTR2009-012037-30-ES
(EUCTR)
27/06/201229/03/2012Hereditary neuromuscular diseaseA Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 ? 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS 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] - Nervous System Diseases [C10]
Product Name: Idebenone
Product Code: SNT-MC17
INN or Proposed INN: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
280Phase 3France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden
21EUCTR2009-012037-30-IT
(EUCTR)
27/03/201226/04/2012(DELOS) DuchEnne MD Long-term IdebenOne StudyA Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS 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: Idebenone
Product Code: NA
INN or Proposed INN: IDEBENONE
SANTHERA PHARMACEUTICALS (SWITZERLAND) LTDNULLNot RecruitingFemale: no
Male: yes
280Phase 3France;United States;Canada;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
22EUCTR2009-012037-30-NL
(EUCTR)
03/06/201017/12/2009Hereditary neuromuscular diseaseA Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS Duchenne Muscular Dystrophy
MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Idebenone
Product Code: SNT-MC17
INN or Proposed INN: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
266Phase 3France;United States;Belgium;Spain;Austria;Germany;Netherlands;Italy;Switzerland;Sweden
23EUCTR2009-012037-30-AT
(EUCTR)
10/03/201010/02/2010Hereditary neuromuscular diseaseA Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS Duchenne Muscular Dystrophy
MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Idebenone
Product Code: SNT-MC17
INN or Proposed INN: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden
24EUCTR2009-012037-30-SE
(EUCTR)
23/02/201028/12/2009Hereditary neuromuscular diseaseA Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS Duchenne Muscular Dystrophy
MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Idebenone
Product Code: SNT-MC17
INN or Proposed INN: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden
25EUCTR2009-012037-30-FR
(EUCTR)
19/02/201017/12/2009A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOSA Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS Duchenne Muscular Dystrophy
MedDRA version: 12.0;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Name: Idebenone
Product Code: SNT-MC17
INN or Proposed INN: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
240Phase 3Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
26EUCTR2009-012037-30-DE
(EUCTR)
08/10/200907/08/2009Hereditary neuromuscular diseaseA Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS Duchenne Muscular Dystrophy
MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Idebenone
Product Code: SNT-MC17
INN or Proposed INN: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden
27EUCTR2009-012037-30-BE
(EUCTR)
14/07/200927/05/2009Hereditary neuromuscular diseaseA Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS Duchenne Muscular Dystrophy
MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Idebenone
Product Code: SNT-MC17
INN or Proposed INN: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden
28NCT01027884
(ClinicalTrials.gov)
July 20098/12/2009Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular DystrophyMuscular Dystrophy, Duchenne;Ambulatory CareDrug: Placebo;Drug: IdebenoneSanthera PharmaceuticalsNULLCompleted10 Years18 YearsMale65Phase 3United States;Austria;Belgium;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland
29NCT00758225
(ClinicalTrials.gov)
September 200823/9/2008Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)A Phase II Open-label Extension Study to Obtain Long-term Safety, Tolerability and Efficacy Data of Idebenone in the Treatment of Duchenne Muscular Dystrophy - Extension to Study SNT-II-001Duchenne Muscular DystrophyDrug: IdebenoneSanthera PharmaceuticalsNULLCompletedN/AN/AMale21Phase 2Belgium
30EUCTR2007-007752-34-BE
(EUCTR)
14/08/200826/06/2008A Phase II open-label extension study to obtain long-term safety, tolerability and efficacy data of Idebenone in the treatment of Duchenne Muscular DystrophyA Phase II open-label extension study to obtain long-term safety, tolerability and efficacy data of Idebenone in the treatment of Duchenne Muscular Dystrophy Duchennes Muscular Dystrophy
MedDRA version: 12.0;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Name: Idebenone
Product Code: SNT-MC17
INN or Proposed INN: Idebenone
Santhera Pharmaceuticals (Switzerland) LtdNULLNot RecruitingFemale: no
Male: yes
Phase 2Belgium
31NCT00654784
(ClinicalTrials.gov)
October 20053/4/2008Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular DystrophyA Phase IIa Double Blind, Randomised, Placebo Controlled, Single Centre Study at the University of Leuven to Assess the Efficacy and Tolerability of Idebenone in 8 - 16 Year Old Males With Cardiac Dysfunction Associated With Duchenne Muscular DystrophyDuchenne Muscular Dystrophy (DMD)Drug: idebenone;Drug: placeboSanthera PharmaceuticalsNULLCompleted8 Years16 YearsMale21Phase 2Belgium
32EUCTR2005-002520-33-BE
(EUCTR)
06/09/200504/10/2005A Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dysfunction associated with Duchenne Muscular DystrophyA Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dysfunction associated with Duchenne Muscular Dystrophy Duchenne Muscular DystrophyProduct Name: idebenoneSanthera Pharmaceuticals LLCNULLNot RecruitingFemale: no
Male: yes
21Phase 2Belgium
33EUCTR2016-000602-10-IE
(EUCTR)
06/02/2018A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
34EUCTR2017-004279-30-SE
(EUCTR)
15/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
35EUCTR2017-004279-30-DE
(EUCTR)
11/06/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
36EUCTR2016-000602-10-SE
(EUCTR)
22/09/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
37EUCTR2017-004279-30-FR
(EUCTR)
14/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNAFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden

302. レーベル遺伝性視神経症


臨床試験数 : 22 薬物数 : 17 - (DrugBank : 4) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 33
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000017939
2013/10/0120/06/2015Multicenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathyMulticenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathy - Clinical trial of Idebenone in patients with LHON Leber hereditary optic neuropathy1. Clinical trial medicine: Idebenone 900mg/day
2. Objectives: 50 patients with LHON
3. Exclusion criteria:
a) A smoker
b) A patient with abnormality of hepatic function
c) A patient who present seizures, delirium and hallucination
d) Pregnancy or Lactation
e) A patient who is associated with agranulocytosis
f) A patient with chronic renal failure
g) A patient with anaphylactic shock against Idebenone
4. Duration of drug administration: 6 months
5. Examinations schedules: Both subjective and objective examinations are performed as following schedules;
a) At the base line: Visual acuity (VA), Critical flicker frequency (CFF), Visual field (VF: Humphry 30-2), central retinal thickness (CRT), functional MRI (f-MRI), searching the mitochondrial mutation
b) 8 weeks: VA, CFF, VF, CRT, f-MRI
c) 16 weeks: VA, CFF, VF, CRT, f-MRI
d) 24 weeks: VA, CFF, VF, CRT, f-MRI
e) 32 weeks: VA, CFF, VF, CRT, f-MRI
f) 40 weeks: VA, CFF, VF, CRT, f-MRI
g) 48 weeks: VA, CFF, VF, CRT, f-MRI
Hyogo College of MedicineKitasato UniversityJikei University School of MedicineTokyo Medical UniversityComplete: follow-up complete10years-old80years-oldMale and Female50Phase 1,2Japan