MD1003 ( DrugBank: - )
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 |
| 10 | シャルコー・マリー・トゥース病 | 2 |
| 13 | 多発性硬化症／視神経脊髄炎 | 14 |
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 1 |
| 20 | 副腎白質ジストロフィー | 2 |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03114215 (ClinicalTrials.gov) | June 29, 2016 | 28/3/2017 | Effect of MD1003 in Amyotrophic Lateral Sclerosis | Effect of MD1003 in Amyotrophic Lateral Sclerosis: a Randomized Double Blind Placebo Controlled Pilot Study | ALS;Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: MD1003;Drug: Placebo oral capsule | MedDay Pharmaceuticals SA | NULL | Completed | 25 Years | 80 Years | All | 30 | Phase 2 | France |
| 2 | EUCTR2015-005810-31-FR (EUCTR) | 03/06/2016 | 24/10/2016 | Effect of MD1003 in amyotrophic lateral sclerosis: a randomized, double blind placebo controlled study | Effect 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 PHARMACEUTICALS | NULL | Not 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): no | France |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02967679 (ClinicalTrials.gov) | December 5, 2016 | 8/11/2016 | SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study | SERENDEM Study: MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study | Chronic Inflammatory Demyelinating Polyneuropathy;Peripheral Neuropathy;Charcot-Marie-Tooth Disease;Charcot-Marie-Tooth Disease Type 1A;Charcot-Marie-Tooth Disease, Type 1B;Anti-MAG Neuropathy | Drug: MD1003 | MedDay Pharmaceuticals SA | NULL | Completed | 20 Years | 85 Years | All | 15 | Phase 2 | France |
| 2 | EUCTR2015-001150-15-FR (EUCTR) | 14/03/2016 | 02/03/2016 | SERENDEM study: high dose biotin in patients suffering from disability related to peripheral nerve diseases | SERENDEM 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 PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | France |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-000700-29-BE (EUCTR) | 12/03/2018 | 08/01/2018 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2016-000700-29-HU (EUCTR) | 27/02/2018 | 28/12/2017 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2016-000700-29-PL (EUCTR) | 15/02/2018 | 15/01/2018 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 4 | EUCTR2016-000700-29-SE (EUCTR) | 07/08/2017 | 14/11/2016 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 5 | EUCTR2016-000700-29-DE (EUCTR) | 08/03/2017 | 16/11/2016 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2016-000700-29-ES (EUCTR) | 10/02/2017 | 09/12/2016 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2016-000700-29-CZ (EUCTR) | 01/02/2017 | 10/11/2016 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 8 | EUCTR2016-000700-29-IT (EUCTR) | 30/01/2017 | 05/11/2020 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Czechia;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 9 | NCT02936037 (ClinicalTrials.gov) | December 2016 | 14/10/2016 | Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) | Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study | Multiple Sclerosis | Drug: MD1003 100mg capsule;Drug: PLACEBO | MedDay Pharmaceuticals SA | NULL | Terminated | 18 Years | 65 Years | All | 642 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Italy;Poland;Spain;Sweden;Turkey;United Kingdom;Czech Republic;Netherlands |
| 10 | EUCTR2013-002112-27-GB (EUCTR) | 28/08/2014 | 07/08/2015 | Effect of MD1003 on visuel impairement of multiple sclerosis | Effect 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | France;United Kingdom | ||
| 11 | NCT02220933 (ClinicalTrials.gov) | October 2013 | 18/8/2014 | Effect of MD1003 in Spinal Progressive Multiple Sclerosis | Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study | Multiple Sclerosis | Drug: MD1003 100mg capsule;Drug: Placebo | MedDay Pharmaceuticals SA | NULL | Active, not recruiting | 18 Years | 75 Years | All | 144 | Phase 3 | France |
| 12 | NCT02220244 (ClinicalTrials.gov) | October 2013 | 18/8/2014 | Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis | Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study | Multiple Sclerosis | Drug: MD1003 100mg capsule | MedDay Pharmaceuticals SA | NULL | Active, not recruiting | 18 Years | 75 Years | All | 105 | Phase 3 | France;United Kingdom |
| 13 | EUCTR2013-002112-27-FR (EUCTR) | 29/05/2015 | Effect of MD1003 on visuel impairement of multiple sclerosis | Effect 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 SAS | NULL | Not Recruiting | Female: yes Male: yes | 0 | Phase 3 | France;United Kingdom | |||
| 14 | EUCTR2013-002113-35-FR (EUCTR) | 29/05/2015 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect 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 SAS | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | France |
14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02967679 (ClinicalTrials.gov) | December 5, 2016 | 8/11/2016 | SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study | SERENDEM Study: MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study | Chronic Inflammatory Demyelinating Polyneuropathy;Peripheral Neuropathy;Charcot-Marie-Tooth Disease;Charcot-Marie-Tooth Disease Type 1A;Charcot-Marie-Tooth Disease, Type 1B;Anti-MAG Neuropathy | Drug: MD1003 | MedDay Pharmaceuticals SA | NULL | Completed | 20 Years | 85 Years | All | 15 | Phase 2 | France |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02961803 (ClinicalTrials.gov) | October 2014 | 9/11/2016 | MD1003-AMN MD1003 in Adrenomyeloneuropathy | MD1003 in Adrenomyeloneuropathy : a Randomized Double Blind Placebo Controlled Study | Adrenomyeloneuropathy;Adrenoleukodystrophy;AMN | Drug: MD1003 100 mg capsule;Drug: Placebo | MedDay Pharmaceuticals SA | NULL | Completed | 18 Years | 60 Years | Male | 67 | Phase 2/Phase 3 | France;Germany;Spain |
| 2 | EUCTR2014-000698-38-ES (EUCTR) | 13/08/2014 | 13/06/2014 | MD1003 IN ADRENOMYELONEUROPATHY | MD1003 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 SAS | NULL | Not Recruiting | Female: no Male: yes | 60 | Phase 2;Phase 3 | Spain |