21. ミトコンドリア病 Mitochondrial disease Clinical trials / Disease details

臨床試験数 : 33 / 薬物数 : 42 - (DrugBank : 32) / 標的遺伝子数 : 47 - 標的パスウェイ数 : 67

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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	EUCTR2021-003907-16-HU (EUCTR)	02/03/2022	04/01/2022	Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjec ...	A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficac ...	Primary Mitochondrial DiseaseResulting from Pathogenic Nuclear DNA Mutations (nPMD) MedDRA version: ...	Product Name: Elamipretide Product Code: MTP-131 INN or Proposed INN: ELAMIPRETIDE Other descriptive na ...	Stealth BioTherapeutics Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 3	United States;Hungary;Finland;Spain;Denmark;Australia;Norway;Netherlands;Germany;United Kingdom;Ital ...
2	NCT05162768 (ClinicalTrials.gov)	March 2022	8/12/2021	Study to Evaluate the Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Dis ...	A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficac ...	Mitochondrial Myopathies;Mitochondrial Pathology;Mitochondrial DNA Mutation;Mitochondrial Diseases;M ...	Drug: Elamipretide;Drug: Placebo	Stealth BioTherapeutics Inc.	NULL	Recruiting	18 Years	70 Years	All	130	Phase 3	United States
3	EUCTR2020-002100-39-ES (EUCTR)	26/07/2021	09/02/2021	A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Diseasein Particip ...	Efficacy and Safety Study of Vatiquinone for the Treatment of Mitochondrial DiseaseSubjects With Ref ...	Genetically determined mitochondrial diseaseand associated refractory epilepsy MedDRA version: 20.0; ...	Product Name: Vatiquinone Product Code: PTC743 INN or Proposed INN: VATIQUINONE Other descriptive name: ...	PTC THERAPEUTICS, INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2;Phase 3	France;United States;Spain;Germany;United Kingdom;Italy
4	EUCTR2021-001268-58-HU (EUCTR)	06/07/2021	21/03/2021	Investigation of effects of cariprazine in patients with mitochondrial schizophrenia	Investigation of cellbiological effects of cariprazine in patients with mitochondrial schizophrenia ...	Mitochondrial diseaseassociated schizophrenia MedDRA version: 20.0;Level: PT;Classification code 100 ...	Trade Name: Reagila Product Name: Reagila	Semmelweis University, STIA-POC-2020	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	10	Phase 4	Hungary
5	NCT04734626 (ClinicalTrials.gov)	May 25, 2021	25/1/2021	Muscle CrCest Muscle Phenotyping in Primary Mitochondrial Disease	Magnetic Resonance Imaging (MRI) Muscle Phenotyping in Mitochondrial Disease	Mitochondrial Diseases	Diagnostic Test: Creatine Chemical Exchange Saturation Transfer (CrCEST) Imaging Sequence	Children's Hospital of Philadelphia	NULL	Recruiting	7 Years	75 Years	All	40		United States
6	EUCTR2020-002100-39-IT (EUCTR)	14/04/2021	04/06/2021	A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Diseasein Particip ...	Efficacy and Safety Study of Vatiquinone for the Treatment of Mitochondrial DiseaseSubjects With Ref ...	Genetically determined mitochondrial diseaseand associated refractory epilepsy MedDRA version: 20.0; ...	Product Name: Vatiquinone Product Code: [PTC743] INN or Proposed INN: VATIQUINONE	PTC THERAPEUTICS INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2;Phase 3	France;United States;Spain;Germany;United Kingdom;Italy;Sweden
7	NCT04846036 (ClinicalTrials.gov)	February 1, 2021	5/2/2021	The KHENERGYC Study	A Randomized Placebo Controlled, Double-blind Phase II Study to Explore the Safety, Efficacy and Pha ...	Mitochondrial Diseases;Mitochondrial DNA tRNALeu(UUR) m.3243A	Drug: Sonlicromanol;Drug: Placebo	Khondrion BV	Julius Clinical, The Netherlands;ProPharma Group;Europees Fonds voor Regionale Ontwikkeling (EFRO);A ...	Recruiting	N/A	17 Years	All	24	Phase 2	Netherlands
8	EUCTR2020-003124-16-NL (EUCTR)	12/01/2021	20/10/2020	The KHENERGYC study: a placebo controlled, double-blind study to explore the safety, efficacy and ph ...	A randomized placebo controlled, double-blind phase II study to explore the safety, efficacy and pha ...	Genetically confirmed mitochondrial disease;Therapeutic area: Diseases [C] - Nutritional and Metabol ...	Product Name: Sonlicromanol Product Code: KH176 INN or Proposed INN: sonlicromanol Other descriptive na ...	Khondrion B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	Netherlands
9	NCT04643249 (ClinicalTrials.gov)	November 10, 2020	13/11/2020	Drug-drug Interaction Study of KL1333 in Healthy Subjects	A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inh ...	Mitochondrial Disease	Drug: KL1333;Drug: Flurbiprofen;Drug: Dextromethorphan;Drug: Bupropion;Drug: Midazolam injection;Drug ...	Abliva AB	NULL	Completed	18 Years	65 Years	All	14	Phase 1	United Kingdom
10	NCT04378075 (ClinicalTrials.gov)	September 28, 2020	4/5/2020	A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Diseasein Particip ...	Efficacy and Safety Study of Vatiquinone for the Treatment of Mitochondrial DiseaseSubjects With Ref ...	Mitochondrial Diseases;Drug Resistant Epilepsy;Leigh Disease;Leigh Syndrome;Mitochondrial Encephalop ...	Drug: Vatiquinone;Other: Placebo	PTC Therapeutics	NULL	Recruiting	N/A	20 Years	All	60	Phase 2/Phase 3	United States;Italy;Spain;United Kingdom

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