158. 結節性硬化症
[臨床試験数:100,薬物数:62(DrugBank:16),標的遺伝子数:35,標的パスウェイ数:115

Searched query = "Tuberous sclerosis", "Tuberous sclerosis complex"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
23 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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1ChiCTR2000031984
2020-05-012020-04-17Sirolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex and EpilepsySirolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex and Epilepsy Tuberous sclerosis complex; Epilepsyexperimental group:Antiepileptic drug + sirolimus;control group:antiepileptic drugs;West China Hospital, Sichuan UniversityNULLPendingBothexperimental group:31;control group:31;N/AChina
2EUCTR2019-000752-34-SK
(EUCTR)
15/11/201901/10/2019 Study to evaluate if the study medication, Rapamycin, topical cream, is effective and safe at treating facial angiofibroma in patients 6 years of age and over. A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-response comparison of the efficacy and safety of a topical rapamycin cream for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in patients 6 years of age and over - Dose-ranging efficacy and safety study of topical rapamycin cream Facial Angiofibromas Associated with Tuberous Sclerosis Complex
MedDRA version: 20.0;Level: PT;Classification code 10002429;Term: Angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Classification code 10073678;Term: Juvenile angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DSLPNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Spain;Australia;New Zealand;United Kingdom
3EUCTR2019-000752-34-HU
(EUCTR)
14/11/201918/11/2019 Study to evaluate if the study medication, Rapamycin, topical cream, is effective and safe at treating facial angiofibroma in patients 6 years of age and over.A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-response comparison of the efficacy and safety of a topical rapamycin cream for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in patients 6 years of age and over - Dose-ranging efficacy and safety study of topical rapamycin cream Facial Angiofibromas Associated with Tuberous Sclerosis Complex
MedDRA version: 20.0;Level: PT;Classification code 10002429;Term: Angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Classification code 10073678;Term: Juvenile angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DSLPNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Spain;Australia;New Zealand;United Kingdom
4NCT03826628
(ClinicalTrials.gov)
July 28, 201929/1/2019Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis ComplexA Phase 2/3, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Response Comparison of the Efficacy and Safety of a Topical Rapamycin Cream for the Treatment of Facial Angiofibromas (FA) Associated With Tuberous Sclerosis Complex (TSC) in Patients 6 Years of Age and OverFacial Angiofibroma;Tuberous SclerosisDrug: rapamycin;Drug: placeboDermatology Specialties Limited PartnershipNULLRecruiting6 Years65 YearsAll120Phase 2/Phase 3United States;Australia;Czechia;Hungary;New Zealand;Slovakia;Spain;United Kingdom
5NCT03363763
(ClinicalTrials.gov)
April 12, 20171/12/2017Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis ComplexPhase 2 Multi Center Prospective Rand. Double Blind Placebo Cont. Parallel Design Study to Evaluate Safety & Efficacy of Topical Sirolimus for Cutaneous Angiofibromas in Subjects W/ Tuberous Sclerosis Complex Followed by Opt. Open LabelAngiofibroma of Face;Tuberous SclerosisDrug: Sirolimus 0.2%;Drug: Sirolimus 0.4%;Drug: Placebo ointmentAucta Pharmaceuticals, IncNULLRecruiting2 Years18 YearsAll45Phase 2United States;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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Target_
size
PhaseCountries
6NCT02634931
(ClinicalTrials.gov)
December 201516/12/2015Long-term Trial of Topical Sirolimus to Angiofibroma in Patient With Tuberous Sclerosis ComplexA Long-term, Single-arm, Open-label Trial of NPC-12G (Topical Formulation of Sirolimus) to Angiofibroma and Other Skin Lesions in Patients With Tuberous Sclerosis ComplexTuberous Sclerosis;Angiofibroma;Hypomelanotic Macule;PlaqueDrug: NPC-12G gelNobelpharmaNULLCompleted3 YearsN/AAll94Phase 3Japan
7NCT02635789
(ClinicalTrials.gov)
December 201515/12/2015Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Sclerosis Complex (TSC)A Double-blind, Randomized, Placebo-controlled Phase III Trial to Investigate the Efficacy and Safety of NPC-12G Gel (Topical Formulation of Sirolimus) to Angiofibroma and Other Skin Lesions in Patients With Tuberous Sclerosis ComplexTuberous Sclerosis;Angiofibroma;Hypomelanotic Macule;PlaqueDrug: NPC-12G gel;Drug: Placebo gelNobelpharmaNULLCompleted3 YearsN/AAll62Phase 3Japan
8JPRN-UMIN000015114
2014/09/1110/09/2014Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex Tuberous sclerosis complexApplication of 0.2% rapamycin gel on skin lesions of the face and trunk twice a day for 12 weeks.Department of Dermatology Graduate School of Medicine, Osaka UniversityNULLRecruitingNot applicable70years-oldMale and Female24Phase 2,3Japan
9NCT02061397
(ClinicalTrials.gov)
March 201423/1/2014Safety of Simvastatin in LAM and TSCThe Safety of Simvastatin (SOS) in Patients With Pulmonary Lymphangioleiomyomatosis (LAM) and With Tuberous Sclerosis Complex (TSC)Lymphangioleiomyomatosis;Tuberous Sclerosis ComplexDrug: Simvastatin;Drug: Sirolimus Oral Product;Drug: Everolimus Oral ProductUniversity of PennsylvaniaThe LAM FoundationCompleted18 YearsN/AFemale10Phase 1/Phase 2United States
10JPRN-UMIN000012420
2013/12/1027/11/2013Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex. Tuberous sclerosis complex0.05% Sirolimus gel(adult)
0.1% Sirolimus gel(adult)
0.2% Sirolimus gel(adult)
0.05% Sirolimus gel(children)
0.1% Sirolimus gel(children)
0.2% Sirolimus gel(children)
Department of DermatologyGraduate School of Medicine, Osaka UniversityNULLComplete: follow-up complete3years-old65years-oldMale and Female36Phase 1,2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
11NCT03140449
(ClinicalTrials.gov)
September 5, 201326/4/2017Topical Rapamycin and Calcitriol for Angiofibroma of Tuberous SclerosisStudy of Combination Therapy With Topical Rapamycin and Calcitriol for Cutaneous Lesions of Tuberous Sclerosis: A Double-blind Randomized Controlled TrialFacial AngiofibromaDrug: Rapamycin;Drug: Calcitriol;Drug: Rapamycin-calcitriol combinationNational Taiwan University HospitalNULLCompleted7 Years65 YearsAll52Phase 3NULL
12NCT01929642
(ClinicalTrials.gov)
July 20137/8/2013Rapalogues for Autism Phenotype in TSC: A Feasibility StudyRapalogues for Autism Phenotype in TSC: A Feasibility StudyTuberous Sclerosis Complex;Self-injury;AutismDrug: Sirolimus;Drug: EverolimusHugo W. Moser Research Institute at Kennedy Krieger, Inc.NULLCompleted2 Years30 YearsAll3Phase 2United States
13EUCTR2011-006308-12-ES
(EUCTR)
16/07/201229/03/2012Clinical trial in patients with tuberous sclerosis for the study of the effects of topical rapamycin in reducing facial tumors associated with the disease ..phase II clinical trial, to study the efficacy and safety of topical rapamycin in reducing facial angiofibromas. Facial tumors (angiofibromas) associated with tuberous sclerosis complex.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Rapamune 1 mg/ml solución oral
INN or Proposed INN: RAPAMUNE
Fundación Investigación Hospital Ramón y CajalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
14NCT01526356
(ClinicalTrials.gov)
May 20121/2/2012Topical Rapamycin to Erase Angiofibromas in TSCPhase II Study of Topical Rapamycin to Erase Angiofibromas in TSC-Multicenter Evaluation of a Novel TherapyAngiofibromas;Tuberous SclerosisDrug: Placebo;Drug: RapamycinThe University of Texas Health Science Center, HoustonNULLCompletedN/AN/AAll179Phase 2United States;Australia
15JPRN-UMIN000006108
2011/08/0103/08/2011Clinical trial for development of topical rapamycin treatment for white macules due to tuberous sclerosis complex, vitiligo vulgaris, and other congenital diseases tuberous sclerosis complex, vitiligo vulgaris, white macules due to congenital diseasesApplication of 0.2% rapamycin gel (base is carboxyvinyl polymer) on white macules of the face twice a day for 12 weeks.
When it is possible, application of 0.2% rapamycin gel twice a day for 12 weeks on white macules of the non-exposed part to the sun.
Department of Dermatology Graduate School of Medicine, Osaka UniversityNULLRecruitingNot applicableNot applicableMale and Female21Phase 2,3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2010-022655-29-NL
(EUCTR)
30/05/201122/10/2010Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial) - RATERandomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial) - RATE Epilepsy in children with Tuberous Sclerosis ComplexTrade Name: RapamuneErasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
17NCT01031901
(ClinicalTrials.gov)
December 200910/12/2009Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1)Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex and Neurofibromatosis 1Tuberous Sclerosis;Neurofibromatoses;Angiofibroma;NeurofibromaDrug: Skincerity;Drug: Skincerity plus sirolimus/rapamycin;Drug: Skinercity plus sirolimus/rapamycinThe University of Texas Health Science Center, HoustonSociety for Pediatric DermatologyCompleted13 YearsN/ABoth52Phase 1United States
18JPRN-UMIN000002844
2009/09/0103/12/2009Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex tuberous sclerosis complexApplication of 0.2% Rapamycin ointment (ointment base is 0.03% tacrolimus ointment) on skin lesion of one side of the face twice a day for 12 weeks.
Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Application of 0.2% Rapamycin ointment (ointment base is white petrolatum) on skin lesion of one side of the face twice a day for 12 weeks.
Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Application of 0.2% Rapamycin gel (base is carboxyvinyl polymer) on skin lesion of one side of the face twice a day for 12 weeks.
Application of gel base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Department of DermatologyGraduate School of Medicine, Osaka UniversityNULLComplete: follow-up completeNot applicableNot applicableMale and Female21Phase 2,3Japan
19NCT01217125
(ClinicalTrials.gov)
October 20086/10/2010Rapamycin In Angiomyolipomas In Patients With Tuberous SclerosisCLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSISAngiomyolipomaDrug: SirolimusFundacio PuigvertMinistry of Health, SpainCompleted10 YearsN/ABoth18Phase 4NULL
20EUCTR2007-005978-30-ES
(EUCTR)
22/01/200803/12/2007Ensayo clínico para evaluar la eficacia y seguridad de la rapamicina en los angiomiolipomas en pacientes con esclerosis tuberosaClinical Trial to Determine the Efficacy and Safety of Rapamycin in Angiomyolipomas in Pacients with Tuberous SclerosisEnsayo clínico para evaluar la eficacia y seguridad de la rapamicina en los angiomiolipomas en pacientes con esclerosis tuberosaClinical Trial to Determine the Efficacy and Safety of Rapamycin in Angiomyolipomas in Pacients with Tuberous Sclerosis Angiomiolipomas en pacientes con esclerosis tuberosa (angiomyolipoma of tuberous sclerosis patients)
MedDRA version: 9.1;Level: LLT;Classification code 10045138;Term: Tuberous sclerosis
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: sirolimus
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: sirolimus
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: sirolimus
FUNDACIÓ PUIGVERTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
21NCT00490789
(ClinicalTrials.gov)
October 200521/6/2007Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAMA Trial of the Efficacy and Safety of Sirolimus(Rapamycin)Therapy for Renal Angiomyolipmoas in Patients With Tuberous Sclerosis Complex and Sporadic LymphangioleiomyomatosisTuberous Sclerosis;LymphangioleiomyomatosisDrug: sirolimusCardiff UniversityUniversity of Nottingham;St Georges Hospital Medical School;Royal Sussex County Hospital;The Tuberous Sclerosis Association;Wyeth is now a wholly owned subsidiary of PfizerActive, not recruiting18 Years65 YearsBoth14Phase 2United Kingdom
22NCT00457808
(ClinicalTrials.gov)
December 20026/4/2007Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAMRapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic LymphangioleiomyomatosisTuberous Sclerosis;LymphangioleiomyomatosisDrug: Rapamycin, sirolimusChildren's Hospital Medical Center, CincinnatiThe LAM Foundation;Tuberous Sclerosis AllianceCompleted18 Years65 YearsBoth25Phase 2United States
23EUCTR2019-000752-34-CZ
(EUCTR)
02/06/2020Study to evaluate if the study medication, Rapamycin, topical cream, is effective and safe at treating facial angiofibroma in patients 6 years of age and over.A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-response comparison of the efficacy and safety of a topical rapamycin cream for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in patients 6 years of age and over - Dose-ranging efficacy and safety study of topical rapamycin cream Facial Angiofibromas Associated with Tuberous Sclerosis Complex
MedDRA version: 20.0;Level: PT;Classification code 10002429;Term: Angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Classification code 10073678;Term: Juvenile angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w
Product Code: Not applicable
INN or Proposed INN: SIROLIMUS
Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w
Product Code: Not applicable
INN or Proposed INN: SIROLIMUS
Dermatology Specialities Limited Partnership (DSLP)NULLNAFemale: yes
Male: yes
120Phase 2;Phase 3United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Australia;New Zealand