MD1003 ( DrugBank: - )


5 diseases
IDDisease name (Link within this page)Number of trials
2Amyotrophic lateral sclerosis2
10Charcot-Marie-Tooth disease2
13Multiple sclerosis/Neuromyelitis optica14
14Chronic inflammatory demyelinating polyneuropathy1
20Adrenoleukodystrophy2

2. Amyotrophic lateral sclerosis


Clinical trials : 645 Drugs : 589 - (DrugBank : 163) / Drug target genes : 150 - Drug target pathways : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03114215
(ClinicalTrials.gov)
June 29, 201628/3/2017Effect of MD1003 in Amyotrophic Lateral SclerosisEffect of MD1003 in Amyotrophic Lateral Sclerosis: a Randomized Double Blind Placebo Controlled Pilot StudyALS;Amyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: MD1003;Drug: Placebo oral capsuleMedDay Pharmaceuticals SANULLCompleted25 Years80 YearsAll30Phase 2France
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

10. Charcot-Marie-Tooth disease


Clinical trials : 41 Drugs : 46 - (DrugBank : 9) / Drug target genes : 11 - Drug target pathways : 15
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02967679
(ClinicalTrials.gov)
December 5, 20168/11/2016SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot StudySERENDEM Study: MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot StudyChronic Inflammatory Demyelinating Polyneuropathy;Peripheral Neuropathy;Charcot-Marie-Tooth Disease;Charcot-Marie-Tooth Disease Type 1A;Charcot-Marie-Tooth Disease, Type 1B;Anti-MAG NeuropathyDrug: MD1003MedDay Pharmaceuticals SANULLCompleted20 Years85 YearsAll15Phase 2France
2EUCTR2015-001150-15-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. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
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
9NCT02936037
(ClinicalTrials.gov)
December 201614/10/2016Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled StudyMultiple SclerosisDrug: MD1003 100mg capsule;Drug: PLACEBOMedDay Pharmaceuticals SANULLTerminated18 Years65 YearsAll642Phase 3United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Italy;Poland;Spain;Sweden;Turkey;United Kingdom;Czech Republic;Netherlands
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
11NCT02220933
(ClinicalTrials.gov)
October 201318/8/2014Effect of MD1003 in Spinal Progressive Multiple SclerosisEffect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled StudyMultiple SclerosisDrug: MD1003 100mg capsule;Drug: PlaceboMedDay Pharmaceuticals SANULLActive, not recruiting18 Years75 YearsAll144Phase 3France
12NCT02220244
(ClinicalTrials.gov)
October 201318/8/2014Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple SclerosisEffect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled StudyMultiple SclerosisDrug: MD1003 100mg capsuleMedDay Pharmaceuticals SANULLActive, not recruiting18 Years75 YearsAll105Phase 3France;United Kingdom
13EUCTR2013-002112-27-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
14EUCTR2013-002113-35-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

14. Chronic inflammatory demyelinating polyneuropathy


Clinical trials : 175 Drugs : 161 - (DrugBank : 41) / Drug target genes : 13 - Drug target pathways : 24
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02967679
(ClinicalTrials.gov)
December 5, 20168/11/2016SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot StudySERENDEM Study: MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot StudyChronic Inflammatory Demyelinating Polyneuropathy;Peripheral Neuropathy;Charcot-Marie-Tooth Disease;Charcot-Marie-Tooth Disease Type 1A;Charcot-Marie-Tooth Disease, Type 1B;Anti-MAG NeuropathyDrug: MD1003MedDay Pharmaceuticals SANULLCompleted20 Years85 YearsAll15Phase 2France

20. Adrenoleukodystrophy


Clinical trials : 61 Drugs : 90 - (DrugBank : 31) / Drug target genes : 23 - Drug target pathways : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02961803
(ClinicalTrials.gov)
October 20149/11/2016MD1003-AMN MD1003 in AdrenomyeloneuropathyMD1003 in Adrenomyeloneuropathy : a Randomized Double Blind Placebo Controlled StudyAdrenomyeloneuropathy;Adrenoleukodystrophy;AMNDrug: MD1003 100 mg capsule;Drug: PlaceboMedDay Pharmaceuticals SANULLCompleted18 Years60 YearsMale67Phase 2/Phase 3France;Germany;Spain
2EUCTR2014-000698-38-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