127. 前頭側頭葉変性症 Frontotemporal lobar degeneration Clinical trials / Disease details
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. | 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 | EUCTR2014-002013-37-NL (EUCTR) | 24/03/2016 | 13/07/2015 | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 966 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 2 | EUCTR2014-002013-37-BE (EUCTR) | 03/06/2015 | 31/03/2015 | An 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 3 | EUCTR2014-002013-37-FI (EUCTR) | 11/05/2015 | 25/03/2015 | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 966 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Belgium;Malaysia;Singapore;Romania;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 4 | EUCTR2014-002013-37-HR (EUCTR) | 04/03/2015 | 31/03/2015 | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 966 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Argentina;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 5 | EUCTR2014-002013-37-ES (EUCTR) | 13/02/2015 | 16/12/2014 | An 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | United 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 | ||
| 6 | EUCTR2014-002013-37-GB (EUCTR) | 06/10/2014 | 20/08/2014 | An 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 Ltd | NULL | Not 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): no | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 7 | NCT02245568 (ClinicalTrials.gov) | August 2014 | 27/8/2014 | Open-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 Dementia | Drug: LMTM | TauRx Therapeutics Ltd | NULL | Terminated | N/A | N/A | All | 913 | Phase 3 | United 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 |
| 8 | EUCTR2011-005529-34-PL (EUCTR) | 11/06/2014 | 11/03/2014 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands | ||
| 9 | EUCTR2011-005529-34-ES (EUCTR) | 07/05/2014 | 01/04/2014 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Finland;Poland;Spain;Singapore;Croatia;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2011-005529-34-HR (EUCTR) | 14/04/2014 | 03/09/2014 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands;United States;Finland;Spain | ||
| 11 | EUCTR2011-005529-34-FI (EUCTR) | 04/04/2014 | 19/02/2014 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2011-005529-34-IT (EUCTR) | 06/02/2014 | 30/12/2013 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 13 | EUCTR2011-005529-34-NL (EUCTR) | 24/06/2013 | 09/08/2012 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Germany;Netherlands;Italy;United Kingdom | ||
| 14 | EUCTR2011-005529-34-GB (EUCTR) | 17/01/2013 | 08/08/2012 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands | ||
| 15 | EUCTR2011-005529-34-DE (EUCTR) | 28/12/2012 | 08/08/2012 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands | ||
| 16 | EUCTR2005-005915-13-GB (EUCTR) | 12/07/2006 | 10/04/2006 | An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromes | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United Kingdom |