BIOTIN ( DrugBank: Biotin )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2
8ハンチントン病2
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12
20副腎白質ジストロフィー1

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03427086
(ClinicalTrials.gov)
January 29, 201829/1/2018Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral SclerosisSafety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Biotin;Drug: Placebo Oral TabletAmerican University of Beirut Medical CenterNULLCompleted18 Years80 YearsAll12Phase 2Lebanon
2EUCTR2015-005810-31-FR
(EUCTR)
03/06/201624/10/2016Effect of MD1003 in amyotrophic lateral sclerosis: a randomized, double blind placebo controlled studyEffect of MD1003 in amyotrophic lateral sclerosis: a randomized, double blind placebo controlled study - MD1003-ALS Amyotrophic lateral sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MD1003
INN or Proposed INN: BIOTIN
MEDDAY PHARMACEUTICALSNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance

8. ハンチントン病


臨床試験数 : 242 薬物数 : 205 - (DrugBank : 62) / 標的遺伝子数 : 85 - 標的パスウェイ数 : 159
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04478734
(ClinicalTrials.gov)
June 1, 202211/2/2020Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's DiseaseMulticentric Trial on the Use of Combined Therapy of Thiamine and Biotine in Patients With Huntington´s DiseaseHuntington DiseaseDrug: Moderate doses of Thiamine y Biotin;Drug: High doses of Thiamine y BiotinFundación Pública Andaluza para la gestión de la Investigación en SevillaCiberned (Centro de Investigación Biomédica en Red)Not yet recruiting18 YearsN/AAll24Phase 2Spain
2EUCTR2019-004360-22-ES
(EUCTR)
22/10/202110/01/2020Trial on the use of thiamine and biotin in patients with Huntington's disease.MULTI-TECHNICAL TEST ON THE USE OF COMBINED THERAPY OF THEMIN AND BIOTINE IN PATIENTS WITH HUNTINGTON'S DISEASE - Huntiam Huntington´s disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Benerva
Product Name: Benerva
Product Name: Biotina
INN or Proposed INN: BIOTIN
Other descriptive name: Vitamin B7
Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas (Ciberned)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2Spain

10. シャルコー・マリー・トゥース病


臨床試験数 : 41 薬物数 : 46 - (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 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03552211
(ClinicalTrials.gov)
May 30, 201825/4/2018Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple SclerosisEvaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: biotin;Other: propensity scoreUniversity Hospital, Clermont-FerrandOFSEP (Observatoire Français de la Sclérose en Plaques);SFSEP (Société Francophone de la Sclérose en Plaques);MedDay Pharmaceuticals SAUnknown status18 Years80 YearsAll3000France
2EUCTR2016-000700-29-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
3EUCTR2016-000700-29-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
4EUCTR2016-000700-29-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
5EUCTR2016-000700-29-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
6EUCTR2016-000700-29-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
7EUCTR2016-000700-29-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
8EUCTR2016-000700-29-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
9EUCTR2016-000700-29-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
10EUCTR2013-002112-27-GB
(EUCTR)
28/08/201407/08/2015Effect of MD1003 on visuel impairement of multiple sclerosisEffect of MD1003 in chronic visual loss related to optic neuritis in multiplesclerosis: a pivotal randomized double masked placebo controlled study - MS-ON chronic visual loss related to optic neuritis in multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10030942;Term: Optic neuritis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Biotin
Product Code: MD1003
INN or Proposed INN: BIOTIN
MEDDAY Pharmaceuticals SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3France;United Kingdom
11EUCTR2013-002112-27-FR
(EUCTR)
29/05/2015Effect of MD1003 on visuel impairement of multiple sclerosisEffect of MD1003 in chronic visual loss related to optic neuritis in multiple sclerosis: a pivotal randomized double masked placebo controlled study - MS-ON chronic visual loss related to optic neuritis in multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;Classification code 10030942;Term: Optic neuritis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: biotin
Product Code: MD1003
INN or Proposed INN: BIOTIN
MEDDAY SASNULLNot RecruitingFemale: yes
Male: yes
0Phase 3France;United Kingdom
12EUCTR2013-002113-35-FR
(EUCTR)
29/05/2015Effect of MD1003 in progressive multiple sclerosis with walking impairmentEffect of MD1003 in spinal progressive multiple sclerosis: a pivotal randomized double blind placebo controlled study - MS-SPI Progressive spinal multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: biotin
Product Code: MD1003
INN or Proposed INN: BIOTIN
MEDDAY SASNULLNot RecruitingFemale: yes
Male: yes
105Phase 3France

20. 副腎白質ジストロフィー


臨床試験数 : 61 薬物数 : 90 - (DrugBank : 31) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
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