2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 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 | EUCTR2015-001431-20-NL (EUCTR) | 17/08/2015 | 21/04/2015 | Trial to look at the nerve conductance in patients with ALS, with and without Riluzole or Retigabine. | A randomized, double blind, double-dummy placebo controlled, 3-way cross-over study to determine the test-retest reliability of, and the effect of oral retigabine and riluzole on, peripheral motor nerve excitability measurements in patients with ALS. - Peripheral motor nerve excitability study in patients with ALS | Amytrophic Lateral Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rilutek 50 mg film-coated tablets Product Name: Rilutek INN or Proposed INN: RILUZOLE Trade Name: Trobalt Product Name: Trobalt INN or Proposed INN: RETIGABINE | Centre for Human Drug Research | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 2 | EUCTR2012-004987-23-ES (EUCTR) | 12/06/2013 | 16/05/2013 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;France;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 3 | EUCTR2012-004987-23-DE (EUCTR) | 29/04/2013 | 17/01/2013 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2 | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 4 | EUCTR2012-004987-23-IE (EUCTR) | 08/02/2013 | 30/11/2012 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2 | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 5 | EUCTR2012-004987-23-GB (EUCTR) | 24/01/2013 | 12/12/2012 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 6 | EUCTR2009-010060-41-IT (EUCTR) | 24/02/2009 | 06/03/2009 | Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND | Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND | Amyotrophic Lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: LITIO CARBONATO INN or Proposed INN: Lithium Trade Name: RILUTEK INN or Proposed INN: Riluzole | AZIENDA OSPEDALIERA PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 7 | JPRN-UMIN000008527 | 2009/01/01 | 25/07/2012 | Study of efficacy and safety of NDDPX08 in ALS patients | Amyotrophic Lateral Sclerosis | For patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level. The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment. Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study. | FeGALS | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 50 | Not selected | Japan | |
| 8 | EUCTR2004-002390-23-DE (EUCTR) | 24/11/2004 | 30/11/2004 | Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjects | Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjects | amyotrophic lateral sclerosis Classification code 10002026 | Trade Name: RILUTEK Product Name: RILUTEK 50 mg, film-coated tablets INN or Proposed INN: riluzole | Aventis Pharma Ltd. | NULL | Not Recruiting | Female: Male: yes | Germany | ||||
| 9 | EUCTR2012-004987-23-NL (EUCTR) | 07/02/2013 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 2 | France;United States;Canada;Spain;Ireland;Germany;Netherlands;United Kingdom |