TUDCA ( DrugBank: TUDCA )


1 disease
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

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
1EUCTR2018-002722-22-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
2EUCTR2018-002722-22-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
3EUCTR2018-002722-22-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
4EUCTR2018-002722-22-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
5NCT03800524
(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
6EUCTR2018-002722-22-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
7NCT03127514
(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
8NCT00877604
(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
9EUCTR2007-001592-10-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