Rilutek ( DrugBank: - )


3 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9
13多発性硬化症/視神経脊髄炎1
20322q11.2欠失症候群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
1EUCTR2015-001431-20-NL
(EUCTR)
17/08/201521/04/2015Trial 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 ResearchNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
2EUCTR2012-004987-23-ES
(EUCTR)
12/06/201316/05/2013A 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 IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;France;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
3EUCTR2012-004987-23-DE
(EUCTR)
29/04/201317/01/2013A 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 IncNULLNot RecruitingFemale: yes
Male: yes
700Phase 2United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
4EUCTR2012-004987-23-IE
(EUCTR)
08/02/201330/11/2012A 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 IncNULLNot RecruitingFemale: yes
Male: yes
700Phase 2United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
5EUCTR2012-004987-23-GB
(EUCTR)
24/01/201312/12/2012A 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 IncNULLNot 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): noUnited States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
6EUCTR2009-010060-41-IT
(EUCTR)
24/02/200906/03/2009Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - NDEvaluation 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 PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
7JPRN-UMIN000008527
2009/01/0125/07/2012Study of efficacy and safety of NDDPX08 in ALS patientsStudy of efficacy and safety of NDDPX08 in ALS patients - NDDPX08-ALS clinical research Amyotrophic Lateral SclerosisFor 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.
FeGALSNULLComplete: follow-up complete20years-old75years-oldMale and Female50Not selectedJapan
8EUCTR2004-002390-23-DE
(EUCTR)
24/11/200430/11/2004Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjectsEvaluation 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.NULLNot RecruitingFemale:
Male: yes
Germany
9EUCTR2012-004987-23-NL
(EUCTR)
07/02/2013A 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 IncNULLNot RecruitingFemale: yes
Male: yes
680Phase 2France;United States;Canada;Spain;Ireland;Germany;Netherlands;United Kingdom

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
1EUCTR2012-005394-31-GB
(EUCTR)
01/04/201405/09/2014MS-SMART: A Trial of Efficacy (usefulness) of 3 Neuroprotective Drugs in SPMSMS-SMART: A Multi-Arm Phase IIb Randomised, Double Blind Placebo-Controlled Clinical Trial Comparing The Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis - MS-SMART: Multiple Sclerosis Secondary Progressive Multi-Arm Randomisation Trial Mutliple Sclerosis (Secondary Progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Rilutek
Product Name: Rilutek
INN or Proposed INN: Riluzole
Trade Name: Amiloride
Product Name: Amiloride
INN or Proposed INN: Amiloride
Trade Name: Fluoxetine
Product Name: Fluoxetine
INN or Proposed INN: Fluoxetine hydrochloride
UCLNULLNot Recruiting Female: yes
Male: yes
440 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom

203. 22q11.2欠失症候群


臨床試験数 : 5 薬物数 : 7 - (DrugBank : 1) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 23
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-002011-61-NL
(EUCTR)
13/08/202121/06/2021Riluzole as treatment for psychotic and cognitive symptoms in 22q11.2 deletion syndromeThe glutamate/GABA balance as novel therapeutic target for psychotic and cognitive symptoms in 22q11.2 deletion syndrome - Riluzole in 22q11.2DS 22q11.2 deletion syndrome;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]Trade Name: Rilutek
Product Name: Riluzole
Product Code: EMEA/H/C/000109
Academisch ziekenhuis MaastrichtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 3Netherlands