Tauroursodeoxycholic acid ( DrugBank: Tauroursodeoxycholic acid )


4 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10
13多発性硬化症/視神経脊髄炎1
93原発性胆汁性胆管炎1
299嚢胞性線維症1

2. 筋萎縮性側索硬化症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000250-26-IT
(EUCTR)
14/12/202118/10/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: AMX0035
Product Code: [AMX0035]
INN or Proposed INN: Sodio phenylbutyrate
INN or Proposed INN: Tauroursodeoxycholic Acid
AMYLYX PHARMACEUTICALS Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
2EUCTR2018-002722-22-NL
(EUCTR)
21/11/201906/06/2019Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;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: TUDCABIL
INN or Proposed INN: tauroursodeoxycholic acid
Other descriptive name: TAUROURSODEOXYCHOLIC ACID
Humanitas Mirasole SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Belgium;Germany;Netherlands;Italy;United Kingdom
3EUCTR2018-002722-22-BE
(EUCTR)
06/06/201919/02/2019Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;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: TUDCABIL
INN or Proposed INN: tauroursodeoxycholic acid
Other descriptive name: TAUROURSODEOXYCHOLIC ACID
Humanitas Mirasole SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3Belgium;Netherlands;Germany;Italy;United Kingdom
4EUCTR2018-002722-22-DE
(EUCTR)
03/06/201905/02/2019Safety and efficacy of a treatment with tauroursodeoxycholic acid (TUDCA) on top of riluzole in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;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: TUDCABIL
INN or Proposed INN: tauroursodeoxycholic acid
Other descriptive name: TAUROURSODEOXYCHOLIC ACID
Humanitas Mirasole SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3Belgium;Netherlands;Germany;Italy;United Kingdom
5EUCTR2018-002722-22-GB
(EUCTR)
20/05/201928/02/2019Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS amyotrophic lateral sclerosis
MedDRA version: 21.1;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: Taurolite
Product Name: Taurolite
INN or Proposed INN: Tauroursodeoxycholic acid
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Netherlands;United Kingdom
6NCT03800524
(ClinicalTrials.gov)
February 22, 20194/1/2019Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALSSafety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Tauroursodeoxycholic Acid;Drug: PlaceboHumanitas Mirasole SpAUniversity of Ulm;University of Sheffield;University Hospital, Tours;KU Leuven;UMC Utrecht;University of Dublin, Trinity College;Bruschettini S.r.l.;Istituto Superiore di Sanità;Motor Neurone Disease Association;European CommissionRecruiting18 Years80 YearsAll440Phase 3Belgium;France;Germany;Ireland;Italy;Netherlands;United Kingdom
7EUCTR2018-002722-22-IT
(EUCTR)
18/12/201818/01/2021Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;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: TUDCABIL
Product Name: TUDCABIL
Product Code: [TUDCA]
INN or Proposed INN: ACIDO TAUROURSODESOSSICOLICO
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3France;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy
8NCT03127514
(ClinicalTrials.gov)
June 22, 201712/4/2017AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for the Treatment of ALSAmyotrophic Lateral Sclerosis;Motor Neuron Disease;Neuromuscular Diseases;Neurodegenerative Diseases;Spinal Cord Diseases;TDP-43 Proteinopathies;Nervous System Diseases;Central Nervous System DiseasesDrug: AMX0035;Other: PlaceboAmylyx Pharmaceuticals Inc.ALS Finding a Cure Foundation;ALS Association;Northeast ALS Consortium;Massachusetts General Hospital Neurology Clinical Research Institute;Leandro P. Rizzuto FoundationCompleted18 Years80 YearsAll137Phase 2/Phase 3United States
9NCT00877604
(ClinicalTrials.gov)
June 20087/4/2009Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral SclerosisA Randomized, Double-blind Multicenter Pilot Study vs. Placebo for the Evaluation of Efficacy and Tolerability of Tauroursodeoxycholic Acid Administered by Oral Route as Add on Treatment in Patients Affected by Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: tauroursodeoxycholic acid (TUDCA);Drug: PlaceboFondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity of Palermo;Federico II UniversityCompleted18 Years75 YearsAll34Phase 2Italy
10EUCTR2007-001592-10-IT
(EUCTR)
15/02/200815/01/2008A randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholicacid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALSA randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholicacid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALS AMYOTROPHIC LATERAL SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: Tauroursodeoxycholic acid
INN or Proposed INN: Tauroursodeoxycholic acid
ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03423121
(ClinicalTrials.gov)
June 19, 201812/1/2018A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS PatientsA Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS PatientsProgressive Multiple SclerosisDrug: Tauroursodeoxycholic Acid;Drug: Placebo oral capsuleJohns Hopkins UniversityNULLRecruiting18 YearsN/AAll60Phase 1/Phase 2United States

93. 原発性胆汁性胆管炎


臨床試験数 : 282 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01857284
(ClinicalTrials.gov)
September 200916/5/2013Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary CirrhosisA Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Tauroursodeoxycholic Acid Capsules;Drug: Ursodeoxycholic Acid CapsulesBeijing Friendship HospitalBeijing Trendful Kangjian Medical Information Consulting Limited CompanyCompleted18 Years70 YearsBoth216Phase 3China

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00004441
(ClinicalTrials.gov)
September 199718/10/1999Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic FibrosisCystic FibrosisDrug: tauroursodeoxycholic acid;Drug: ursodiolChildren's Hospital Medical Center, CincinnatiNULLCompletedN/AN/ABoth39N/AUnited States;Italy