13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
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. | 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 | NCT01416363 (ClinicalTrials.gov) | May 20, 2011 | 23/6/2011 | Healthy Volunteer Study Using 3 Different Formulations of Firategrast | A Single/Repeat Dose Study With Three Oral Formulations of Firategrast (Immediate Release Tablet, Modified Release Tablet, and Naso-gastric Infusion) in Healthy Male Volunteers | Multiple Sclerosis, Relapsing-Remitting | Drug: Firategrast immediate release tablet;Drug: Firategrast modified release tablet;Drug: Firategrast gastro-retentive solution | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Male | 38 | Phase 1 | Australia |
| 2 | EUCTR2006-002633-20-LT (EUCTR) | 07/09/2007 | 05/07/2007 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 3 | EUCTR2006-002633-20-FR (EUCTR) | 04/07/2007 | 11/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 4 | NCT00469378 (ClinicalTrials.gov) | July 2007 | 2/5/2007 | Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple Sclerosis | An Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With Firategrast | Multiple Sclerosis | Drug: firategrast | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 46 | Phase 2 | Belgium;Czech Republic;Denmark;Norway;Sweden |
| 5 | EUCTR2006-007057-42-DK (EUCTR) | 25/06/2007 | 14/05/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Denmark;Sweden | |||
| 6 | EUCTR2006-007057-42-BE (EUCTR) | 29/05/2007 | 14/02/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Belgium;Denmark;Sweden | |||
| 7 | EUCTR2006-007057-42-CZ (EUCTR) | 03/05/2007 | 16/03/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Belgium;Denmark;Sweden | ||
| 8 | EUCTR2006-007057-42-SE (EUCTR) | 02/05/2007 | 15/02/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Denmark;Sweden | |||
| 9 | NCT00548769 (ClinicalTrials.gov) | April 21, 2007 | 23/10/2007 | Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients | An Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple Sclerosis | Multiple Sclerosis | Drug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation D | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 37 | Phase 1 | Czechia;Germany;Poland;Czech Republic |
| 10 | EUCTR2006-002633-20-IT (EUCTR) | 26/03/2007 | 05/02/2007 | Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple sclerosis MedDRA version: 14.1;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: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | |||
| 11 | EUCTR2006-002633-20-GB (EUCTR) | 25/01/2007 | 10/02/2012 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 12 | EUCTR2006-002633-20-FI (EUCTR) | 05/12/2006 | 04/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 13 | EUCTR2006-002633-20-ES (EUCTR) | 01/12/2006 | 13/04/2012 | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Esclerosis múltiple remitente-recurrente MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline S.A | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Finland;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Norway;New Zealand | ||
| 14 | NCT00395317 (ClinicalTrials.gov) | December 2006 | 1/11/2006 | Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS) | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Other: Placebo;Drug: Firategrast 150 mg;Drug: Firategrast 300 mg | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 343 | Phase 2 | Australia;Austria;Canada;Finland;France;Germany;Italy;Netherlands;New Zealand;Norway;Poland;Russian Federation;Spain;United Kingdom;Lithuania |
| 15 | EUCTR2006-002633-20-NL (EUCTR) | 17/11/2006 | 10/08/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 16 | EUCTR2006-002633-20-DE (EUCTR) | 25/10/2006 | 23/08/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy | |||
| 17 | EUCTR2006-002633-20-AT (EUCTR) | 05/10/2006 | 14/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania |