Nicotinamide ( DrugBank: Nicotinamide )


8 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1
6パーキンソン病3
18脊髄小脳変性症(多系統萎縮症を除く。)6
49全身性エリテマトーデス1
65原発性免疫不全症候群2
107若年性特発性関節炎2
162類天疱瘡(後天性表皮水疱症を含む。)1
191ウェルナー症候群1

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 623 - (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
1NCT04562831
(ClinicalTrials.gov)
October 7, 202010/9/2020The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS.A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS StudyAmyotrophic Lateral SclerosisDietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene)Haukeland University HospitalElysium HealthRecruiting35 YearsN/AAll380N/ANorway

6. パーキンソン病


臨床試験数 : 2,298 薬物数 : 2,218 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03568968
(ClinicalTrials.gov)
May 15, 202014/6/2018A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's DiseaseA Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK StudyParkinson DiseaseDietary Supplement: Nicotinamide Riboside;Drug: PlaceboHaukeland University HospitalNULLRecruiting18 YearsN/AAll400N/ANorway
2NCT03816020
(ClinicalTrials.gov)
March 9, 20197/12/2018NAD-supplementation in Drug naïve Parkinson's DiseaseNAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's DiseaseParkinson Disease;Neurodegenerative DiseasesDietary Supplement: Nicotinamide Riboside;Other: PlaceboHaukeland University HospitalNULLCompleted18 YearsN/AAll30N/ANorway
3EUCTR2004-005034-39-GB
(EUCTR)
17/05/200520/04/2005Nicotinamide,vitamin B3, metabolic pathways in patients with early idiopathic parkinson's diseaseNicotinamide,vitamin B3, metabolic pathways in patients with early idiopathic parkinson's disease Idiopathic Parkinson's diseaseTrade Name: Nicotinamide
Product Name: NICOTINAMIDE
INN or Proposed INN: Nicotinamide
Queen Elizabeth HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom

18. 脊髄小脳変性症(多系統萎縮症を除く。)


臨床試験数 : 71 薬物数 : 101 - (DrugBank : 30) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 65
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03761511
(ClinicalTrials.gov)
April 202227/11/2018Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich AtaxiaA Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich AtaxiaFriedreich AtaxiaDrug: Nicotinamide;Drug: PlaceboRWTH Aachen UniversityAssistance Publique - Hôpitaux de ParisNot yet recruiting18 YearsN/AAll225Phase 2Austria;France;Germany;Italy;Spain;United Kingdom
2NCT04192136
(ClinicalTrials.gov)
September 3, 20206/12/2019NAD+ and Exercise in FANAD+ Precursor Supplementation With Exercise Training to Increase Aerobic Capacity in Friedreich's AtaxiaFriedreich Ataxia 1Dietary Supplement: Nicotinamide Riboside;Dietary Supplement: Placebo;Other: Exercise InterventionChildren's Hospital of PhiladelphiaNational Institutes of Health (NIH)Recruiting10 Years40 YearsAll72N/AUnited States
3EUCTR2017-002163-17-ES
(EUCTR)
08/04/202023/01/2020MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA.A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA. - NICOFA Friedreich Ataxia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Nicotinamide
INN or Proposed INN: NICOTINAMIDE
RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical FacultyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2;Phase 3Spain;Austria;Germany;United Kingdom
4EUCTR2017-002163-17-GB
(EUCTR)
21/01/202031/10/2019Use of Nicotinamide for the Treatment of Patients with Friedreich's Ataxia.A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICH´S ATAXIA (NICOFA) - NICOFA Friedreich's ataxia.Friedreich ataxia is the most frequent early-onset autosomal recessive hereditary ataxia. It is caused by a pathological expansion of a GAA repeat in the first intron of the frataxin gene (FXN) and results in decreased levels of FXN protein. FXN deficiency results in a relentlessly progressive neurodegenerative condition which frequently presents around puberty. Patients gradually lose coordination, become dysarthric and are frequently wheelchair-bound as adolescents.
MedDRA version: 20.0;Level: PT;Classification code 10017374;Term: Friedreich's ataxia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Nicotinamide
Product Name: Nicotinamide
INN or Proposed INN: Nicotinamide
Other descriptive name: SUB09246MIG
RWTH Aachen University, Center for Translational & Clinical Research Aachen (CTC-A)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2;Phase 3Spain;Austria;Germany;United Kingdom
5EUCTR2017-002163-17-AT
(EUCTR)
04/09/201901/08/2019A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA.A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA. - NICOFA Friedreich Ataxia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Nicotinamide
INN or Proposed INN: NICOTINAMIDE
RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical FacultyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2;Phase 3Austria;Germany
6EUCTR2017-002163-17-DE
(EUCTR)
25/10/201820/11/2017A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA.A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA. - NICOFA Friedreich Ataxia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Nicotinamide
INN or Proposed INN: NICOTINAMIDE
RWTH Aachen University represented by the Center for Translational & Clinical Research Aachen (CTC-A)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2;Phase 3Spain;Austria;Germany;United Kingdom

49. 全身性エリテマトーデス


臨床試験数 : 946 薬物数 : 733 - (DrugBank : 186) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 198
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03260166
(ClinicalTrials.gov)
August 31, 201710/8/2017Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus ErythematosusAn Open-label Study for Assessing the Efficacy and Safety of Nicotinamide Treatment for Lupus-associated Skin Lesions in Patients With Cutaneous Lupus Erythematosus or Systemic Lupus ErythematosusCutaneous Lupus Erythematosus;Systemic Lupus Erythematosus RashDrug: nicotinamideSecond Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China;Hunan Provincial Natural Science Foundation of China;National Key Clinical Specialty Construction Project of ChinaActive, not recruiting18 Years65 YearsAll40Phase 2China

65. 原発性免疫不全症候群


臨床試験数 : 482 薬物数 : 661 - (DrugBank : 119) / 標的遺伝子数 : 90 - 標的パスウェイ数 : 211
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04870866
(ClinicalTrials.gov)
June 5, 201923/4/2021NAD Supplementation to Prevent Progressive Neurological Disease in Ataxia TelangiectasiaNAD Supplementation to Prevent Progressive Neurological Disease in Ataxia TelangiectasiaAtaxia TelangiectasiaDrug: Nicotinamide ribonucleosideUniversity Hospital, AkershusThe Bergesen Foundation;South-Eastern Norway Regional Health Authority;Sykehuset Innlandet HF;Oslo University Hospital;St. Olavs Hospital;Haukeland University Hospital;University Hospital of North Norway;University of BergenActive, not recruiting3 YearsN/AAll13Phase 2Norway
2NCT03962114
(ClinicalTrials.gov)
March 18, 201911/4/2019Effects of Vitamin B3 in Patients With Ataxia TelangiectasiaEffects of Nicotinamide Riboside (Vitamin B3) in Patients With Ataxia Telangiectasia.Ataxia Telangiectasia;ATM Gene MutationDietary Supplement: Vitamin B3Radboud UniversityA-T childrens project;Twan foundationEnrolling by invitation2 YearsN/AAll24Phase 2Netherlands

107. 若年性特発性関節炎


臨床試験数 : 441 薬物数 : 292 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002245-11-NL
(EUCTR)
16/01/201920/08/2018A study to investigate Vitamin B3 concentrations in the joint after intake Assessing penetration of high dose Nicotinamide (Vitamin B3) in synovial fluid - B-Vit in the joint Juvenile Idiopathic Arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: nicotinamide
Product Code: 98-92-0
INN or Proposed INN: NICOTINAMIDE
Other descriptive name: Vitamin B3
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
6 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands
2EUCTR2016-003643-10-NL
(EUCTR)
14/09/2017A study to investigate the safety of additional treatment with Vitamin B3 in children with Juvenile Idiopathic Arthritis (JIA)Modulating regulatory T cell function in JIA with Vitamin B3 (nicotinamide) treatment - B-Vit in JIA Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: nicotinamide
Product Code: 98-92-0
UMC UtrechtNULLNAFemale: yes
Male: yes
Phase 1;Phase 2Netherlands

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 83 薬物数 : 129 - (DrugBank : 51) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR-TRC-12003592
2011-08-012012-12-30Use of Tripterygium glycosides and Nicotinamide plus Minocycline for the Treatment of bullous pemphigoid: A multicenter,randomized and controlled clinincal trialGuideline-oriented Research in the Management of Some Common and Severe Skin Diseases Bullous pemphigoidTripterygium glycosides group:Take tripterygium glycosides orally at 20 mg, 3 times a day;Nicotinamide plus Minocycline group:Take nicotinamide at 500 mg, 3 times a day and minocycline 100 mg, twice a day.;Institute of dermatology, Chinese Academy of Medical SciencesNULLCompleted18BothTripterygium glycosides group:100;Nicotinamide plus Minocycline group:100;China

191. ウェルナー症候群


臨床試験数 : 3 薬物数 : 4 - (DrugBank : 3) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 5
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs031190141
19/03/202127/11/2019Cross-over trial to verify safety and effectiveness of nicotinamide riboside for patients with Werner syndromeProspective, single-center, cross-over trial to verify safety and effectiveness of nicotinamide riboside for patients with Werner syndrome - EMPOWER Werner syndrome
Werner syndrome;C16.320.925 / C18.452.284.960
Subjects ingest oral capsules of NR (nicotinamide riboside) once daily (total daily dose: nicotinamide riboside 1000 mg).Yokote KoutaroNULLRecruiting>= 20age oldNot applicableBoth30Phase 1-2Japan