LMTM/TRx0237 ( DrugBank: LMTM )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
127前頭側頭葉変性症14

127. 前頭側頭葉変性症


臨床試験数 : 90 薬物数 : 87 - (DrugBank : 30) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 88
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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gender
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size
PhaseCountries
1EUCTR2014-002013-37-NL
(EUCTR)
24/03/201613/07/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
2EUCTR2014-002013-37-BE
(EUCTR)
03/06/201531/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
3EUCTR2014-002013-37-FI
(EUCTR)
11/05/201525/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Belgium;Malaysia;Singapore;Romania;Croatia;Australia;Netherlands;Germany;Korea, Republic of
4EUCTR2014-002013-37-HR
(EUCTR)
04/03/201531/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Argentina;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
5EUCTR2014-002013-37-ES
(EUCTR)
13/02/201516/12/2014An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer?s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer?s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 17.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Taiwan;Finland;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
6EUCTR2014-002013-37-GB
(EUCTR)
06/10/201420/08/2014An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot Recruiting Female: yes
Male: yes
966 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
7EUCTR2011-005529-34-PL
(EUCTR)
11/06/201411/03/2014A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands
8EUCTR2011-005529-34-ES
(EUCTR)
07/05/201401/04/2014A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 16.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N?,N?-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Finland;Poland;Spain;Singapore;Croatia;Australia;Netherlands;Germany;Italy;United Kingdom
9EUCTR2011-005529-34-HR
(EUCTR)
14/04/201403/09/2014A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands;United States;Finland;Spain
10EUCTR2011-005529-34-FI
(EUCTR)
04/04/201419/02/2014A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 17.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Netherlands;Germany;Italy;United Kingdom
11EUCTR2011-005529-34-IT
(EUCTR)
06/02/201430/12/2013A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 16.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Netherlands;Germany;United Kingdom;Italy
12EUCTR2011-005529-34-NL
(EUCTR)
24/06/201309/08/2012A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 17.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Germany;Netherlands;Italy;United Kingdom
13EUCTR2011-005529-34-GB
(EUCTR)
17/01/201308/08/2012A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 18.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands
14EUCTR2011-005529-34-DE
(EUCTR)
28/12/201208/08/2012A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands