D-BIOTIN ( DrugBank: Biotin, D-Biotin )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
10シャルコー・マリー・トゥース病1
13多発性硬化症/視神経脊髄炎8
20副腎白質ジストロフィー1

10. シャルコー・マリー・トゥース病


臨床試験数 : 39 薬物数 : 44 - (DrugBank : 9) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 15
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001150-15-FR
(EUCTR)
14/03/201602/03/2016SERENDEM study: high dose biotin in patients suffering from disability related to peripheral nerve diseasesSERENDEM study: MD1003 in patients suffering from demyelinating neuropathies, an open label pilot study chronic inflammatory demyelinating polyradiculoneuropathy, demyelinating neuropathy associated with immunoglobulin M (IgM) monoclonal gammopathy and antibodies against myelin-associated glycoprotein (MAG), Charcot Marie Tooth Ia (CMT Ia) neuropathy
MedDRA version: 18.1;Level: LLT;Classification code 10066137;Term: Anti-MAG neuropathy;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
15Phase 2France

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000700-29-BE
(EUCTR)
12/03/201808/01/2018Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study. - SPI2 Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: D-Biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY PHARMACEUTICALS SANULLNot RecruitingFemale: yes
Male: yes
754Phase 3United States;Spain;Turkey;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden
2EUCTR2016-000700-29-HU
(EUCTR)
27/02/201828/12/2017Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study. - SPI2 Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: D-Biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY PHARMACEUTICALS SANULLNot RecruitingFemale: yes
Male: yes
754Phase 3United States;Spain;Turkey;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
3EUCTR2016-000700-29-PL
(EUCTR)
15/02/201815/01/2018Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study. - SPI2 Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: D-Biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY PHARMACEUTICALS SANULLNot RecruitingFemale: yes
Male: yes
754Phase 3United States;Spain;Turkey;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden
4EUCTR2016-000700-29-SE
(EUCTR)
07/08/201714/11/2016Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized-double blind placebo-controlled study. - SPI2 Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: D-Biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY PHARMACEUTICALS SANULLNot RecruitingFemale: yes
Male: yes
754Phase 3United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
5EUCTR2016-000700-29-DE
(EUCTR)
08/03/201716/11/2016Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study. - SPI2 Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: D-Biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY PHARMACEUTICALS SANULLNot RecruitingFemale: yes
Male: yes
754Phase 3United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
6EUCTR2016-000700-29-ES
(EUCTR)
10/02/201709/12/2016Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study. - SPI2 Multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: D-Biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY PHARMACEUTICALS SANULLNot RecruitingFemale: yes
Male: yes
375Phase 3United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy;Sweden
7EUCTR2016-000700-29-CZ
(EUCTR)
01/02/201710/11/2016Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study. - SPI2 Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: D-Biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY PHARMACEUTICALS SANULLNot RecruitingFemale: yes
Male: yes
754Phase 3United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
8EUCTR2016-000700-29-IT
(EUCTR)
30/01/201705/11/2020Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study - SPI2 Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: D-Biotin
Product Code: [MD1003]
INN or Proposed INN: D-BIOTINA
Other descriptive name: -
MEDDAY PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
754Phase 3United States;Czechia;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden

20. 副腎白質ジストロフィー


臨床試験数 : 53 薬物数 : 88 - (DrugBank : 31) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 123
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-000698-38-ES
(EUCTR)
13/08/201413/06/2014MD1003 IN ADRENOMYELONEUROPATHYMD1003 IN ADRENOMYELONEUROPATHY: A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY - MD1003-AMN Adrenomyeloneuropathy
MedDRA version: 17.0;Level: LLT;Classification code 10069075;Term: Adrenomyeloneuropathy without cerebral involvement;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: biotin
Product Code: MD1003
INN or Proposed INN: D-BIOTIN
MEDDAY SASNULLNot RecruitingFemale: no
Male: yes
60Phase 2;Phase 3Spain