Methylthioninium ( DrugBank: Methylthioninium )


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16

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
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
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
7NCT02245568
(ClinicalTrials.gov)
August 201427/8/2014Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)Alzheimer's Disease;Behavioral Variant Frontotemporal DementiaDrug: LMTMTauRx Therapeutics LtdNULLTerminatedN/AN/AAll913Phase 3United States;Australia;Belgium;Canada;Croatia;Finland;France;Germany;Korea, Republic of;Malaysia;Netherlands;Romania;Russian Federation;Singapore;Spain;Taiwan;United Kingdom;Argentina;Bulgaria;Italy;Poland
8EUCTR2011-005529-34-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
9EUCTR2011-005529-34-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
10EUCTR2011-005529-34-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
11EUCTR2011-005529-34-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
12EUCTR2011-005529-34-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
13EUCTR2011-005529-34-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
14EUCTR2011-005529-34-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
15EUCTR2011-005529-34-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
16EUCTR2005-005915-13-GB
(EUCTR)
12/07/200610/04/2006An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromesAn Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromes Frontotemporal Dementia and related syndromes Prevention and reversal of tau protein aggregation is a novel approach to the treatment of patients with FTD and related syndromes and has the potential for slowing the disease process as well as providing symptomatic improvement in hitherto untreatable, ultimately fatal conditions.
MedDRA version: 8.1;Level: PT;Classification code 10012267
Product Name: Methylthioninium chloride
Product Code: MTC TRx0014-001 capsules
TauRx Therapeutics PTE LtdNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United Kingdom