EPI-589 ( DrugBank: EPI-589 )


2 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5
6パーキンソン病3

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 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
1JPRN-jRCT2071220047
26/08/202227/08/2022Formulation Pharmacokinetics Study of EPI-589Formulation Pharmacokinetics Study of EPI-589 (DA350102) Amyotrophic lateral sclerosisSubjects receive a test formulation (containing 1000 mg of EPI-589) or a reference formulation (containing 1000 mg of EPI-589) once orally in period 1 and period 2.Hamatani TatsutoNULLRecruiting>= 20age old< 55age oldMale24Phase 1Japan
2JPRN-jRCT2061210031
04/10/202127/08/2021EPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALSEPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALS - EPIC-ALS Amyotrophic Lateral SclerosisEPI-589 500 mg (2 tablets of EPI-589 250 mg) is orally administered three times a day before meals (at least one hour before breakfast, lunch, and dinner). The treatment period will be from the day after the registration of the treatment period to the end of the examination at 24 weeks of the treatment period.Fujita KojiNULLNot Recruiting>= 18age old<= 79age oldBoth10Phase 2Japan
3JPRN-jRCT2071210023
17/05/202117/05/2021Clinical Pharmacology Study of EPI-589Clinical Pharmacology Study of EPI-589 (DA350101) Amyotrophic lateral sclerosisCohort 1 : multiple oral administration, 750 mg, three times a day, EPI-589 or placebo
Cohort 2 : multiple oral administration, 1000 mg, three times a day, EPI-589 or placebo
Cohort 3 : multiple oral administration, 1250 mg, three times a day, EPI-589 or placebo
Cohort 4 : multiple oral administration, 1500 mg, three times a day, EPI-589 or placebo
Cohort 5 : multiple oral administration, 1500 mg, three times a day, EPI-589 or placebo
Hamatani TatsutoNULLRecruiting>= 20age old<= 55age oldMale40Phase 1Japan
4JPRN-jRCT2071210022
03/07/201812/05/2021Clinical Pharmacology Study of EPI-589Clinical Pharmacology Study of EPI-589 (DA301006) Amyotrophic lateral sclerosisPart A : Single oral administration (EPI-589 250, 500, 1000 mg/day or placebo)
Part B : Single oral administration (EPI-589 500 mg/day or placebo)
Part C : Multiple oral administration (EPI-589 1000, 1500 mg/day or placebo)
Part D : Single oral administration (EPI-589 500 mg/day)
Hamatani TatsutoNULLComplete>= 20age old<= 55age oldMale68Phase 1Japan
5NCT02460679
(ClinicalTrials.gov)
January 14, 201621/5/2015Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)A Phase 2A Safety and Biomarker Study of EPI-589 in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: EPI-589PTC TherapeuticsNULLCompleted21 Years70 YearsAll19Phase 2United States

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001786-10-DE
(EUCTR)
24/10/201607/04/2016A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease. A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: EPI-589
Product Code: EPI-589
INN or Proposed INN: Kinoquinone (proposed)
Other descriptive name: (R)-troloxamide quinone
BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)NULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Germany;United Kingdom
2NCT02462603
(ClinicalTrials.gov)
March 31, 201620/5/2015Safety and Biomarker Study of EPI-589 in Parkinson's DiseaseA Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease SubjectsParkinson's DiseaseDrug: EPI-589PTC TherapeuticsNULLCompleted21 Years75 YearsAll44Phase 2United States;Germany;United Kingdom
3EUCTR2015-001786-10-GB
(EUCTR)
18/01/201623/11/2015A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: EPI-589
Product Code: EPI-589
Other descriptive name: (R)-troloxamide quinone
BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Germany;United Kingdom