158. Tuberous sclerosis Clinical trials / Disease details

Clinical trials : 108 / Drugs : 67 - (DrugBank : 17) / Drug target genes : 35 - Drug target pathways : 118

26 trials found

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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	NCT05104983 (ClinicalTrials.gov)	October 13, 2021	22/10/2021	Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study	Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study	Tuberous Sclerosis Complex;Epilepsy	Drug: Sirolimus;Drug: Placebo	Darcy Krueger	NULL	Recruiting	N/A	6 Months	All	64	Phase 2	United States
2	NCT04595513 (ClinicalTrials.gov)	September 8, 2020	6/10/2020	Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants	Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants	Tuberous Sclerosis Complex;Epilepsy	Drug: TAVT-18 (sirolimus)	Children's Hospital Medical Center, Cincinnati	NULL	Active, not recruiting	N/A	6 Months	All	5	Phase 1/Phase 2	United States
3	ChiCTR2000031984	2020-05-01	2020-04-17	Sirolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex and Epilepsy	Sirolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex and Epilepsy	Tuberous sclerosis complex; Epilepsy	experimental group:Antiepileptic drug + sirolimus;control group:antiepileptic drugs;	West China Hospital, Sichuan University	NULL	Pending			Both	experimental group:31;control group:31;	N/A	China
4	EUCTR2019-000752-34-SK (EUCTR)	15/11/2019	01/10/2019	Study to evaluate if the study medication, Rapamycin, topical cream, is effective and safe at treati ...	A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-respon ...	Facial Angiofibromas Associated with Tuberous Sclerosis Complex MedDRA version: 20.0;Level: PT;Class ...	Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w Product Code: Not applicable INN or Proposed INN ...	DSLP	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	United States;Hungary;Slovakia;Spain;Australia;New Zealand;United Kingdom
5	EUCTR2019-000752-34-HU (EUCTR)	14/11/2019	18/11/2019	Study to evaluate if the study medication, Rapamycin, topical cream, is effective and safe at treati ...	A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-respon ...	Facial Angiofibromas Associated with Tuberous Sclerosis Complex MedDRA version: 20.0;Level: PT;Class ...	Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w Product Code: Not applicable INN or Proposed INN ...	DSLP	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	United States;Hungary;Slovakia;Spain;Australia;New Zealand;United Kingdom
6	NCT03826628 (ClinicalTrials.gov)	July 28, 2019	29/1/2019	Dose-Ranging Efficacy and Safety Study of Topical RapamycinCream for Facial Angiofibroma Associated ...	A Phase 2/3, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Respon ...	Facial Angiofibroma;Tuberous Sclerosis	Drug: rapamycin;Drug: placebo	Dermatology Specialties Limited Partnership	NULL	Recruiting	6 Years	65 Years	All	120	Phase 2/Phase 3	United States;Australia;Czechia;Hungary;New Zealand;Serbia;Slovakia;Spain;Taiwan;United Kingdom
7	NCT03363763 (ClinicalTrials.gov)	April 12, 2017	1/12/2017	Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex	Phase 2 Multi Center Prospective Rand. Double Blind Placebo Cont. Parallel Design Study to Evaluate ...	Angiofibroma of Face;Tuberous Sclerosis	Drug: Sirolimus 0.2%;Drug: Sirolimus 0.4%;Drug: Placebo ointment	Aucta Pharmaceuticals, Inc	NULL	Recruiting	2 Years	21 Years	All	45	Phase 2	United States;China
8	NCT02634931 (ClinicalTrials.gov)	December 2015	16/12/2015	Long-term Trial of Topical Sirolimus to Angiofibroma in Patient With Tuberous Sclerosis Complex	A Long-term, Single-arm, Open-label Trial of NPC-12G (Topical Formulation of Sirolimus) to Angiofibr ...	Tuberous Sclerosis;Angiofibroma;Hypomelanotic Macule;Plaque	Drug: NPC-12G gel	Nobelpharma	NULL	Completed	3 Years	N/A	All	94	Phase 3	Japan
9	NCT02635789 (ClinicalTrials.gov)	December 2015	15/12/2015	Phase III Trial of Topical Formulation of Sirolimusto Skin Lesions in Patients With Tuberous Scleros ...	A Double-blind, Randomized, Placebo-controlled Phase III Trial to Investigate the Efficacy and Safet ...	Tuberous Sclerosis;Angiofibroma;Hypomelanotic Macule;Plaque	Drug: NPC-12G gel;Drug: Placebo gel	Nobelpharma	NULL	Completed	3 Years	N/A	All	62	Phase 3	Japan
10	JPRN-UMIN000015114	2014/09/11	10/09/2014	Clinical study of safety and efficacy of rapamycintopical medication for skin lesions due to tuberou ...		Tuberous sclerosis complex	Application 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 University	NULL	Recruiting	Not applicable	70years-old	Male and Female	24	Phase 2,3	Japan

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