SABRIL ( DrugBank: - )

2 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
145	ウエスト症候群	8
158	結節性硬化症	4

145. ウエスト症候群

臨床試験数 : 43 / 薬物数 : 52 - (DrugBank : 15) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 26

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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	EUCTR2021-003015-26-ES (EUCTR)	12/04/2022	25/10/2021	Treatment of Infantile Spasms	A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to V ...	Monotherapy for the treatment of infantile spasms (IS) in infants and children2 months to 24 months ...	Product Name: AMZ002 Product Code: AMZ002 INN or Proposed INN: Vigabatrin Trade Name: Sabril Product Nam ...	Amzell B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	230	Phase 3	France;United States;Poland;Spain
2	EUCTR2017-004775-30-FI (EUCTR)	09/05/2018	08/05/2018	PREDICTION AND PREVENTION OF INFANTILE SPASM SYNDROME IN HIGH RISK CHILDREN	PREDICTION AND PREVENTION OF INFANTILE SPASMS IN HIGH RISK CHILDREN - PREV-IS	Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Sabrilex Product Name: Sabrilex INN or Proposed INN: VIGABATRIN	Kirsi Mikkonen/Helsinki University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 4	Finland
3	NCT02220114 (ClinicalTrials.gov)	May 2014	14/8/2014	Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Sp ...	Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Sp ...	Infantile Spasms	Drug: Vigabatrin: Vigabatrin new ST formulation then Sabril®	Orphelia Pharma	Institut National de la Santé Et de la Recherche Médicale, France;Hospices Civils de Lyon;National R ...	Completed	1 Month	6 Years	All	38	N/A	France
4	EUCTR2006-000788-27-DE (EUCTR)	23/09/2010	11/06/2010	International Collaborative Study of a type of epilepsy called Infantile Spasms	International Collaborative Infantile Spasms Study (ICISS) - ICISS	Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually und ...	Trade Name: SABRIL INN or Proposed INN: Vigabatrin Trade Name: Synacthen Depot INN or Proposed INN: Tet ...	Royal United Hospital Bath NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	410	Phase 4	Australia;Germany;United Kingdom;Switzerland;New Zealand
5	NCT01073579 (ClinicalTrials.gov)	August 2009	22/2/2010	Sabril Patient Registry	Sabril Patient Registry	Infantile Spasms;Refractory Complex Partial Seizures in Adults	Drug: Sabril®	Lundbeck LLC	NULL	Completed	N/A	N/A	Both	9423	N/A	NULL
6	EUCTR2006-000788-27-GB (EUCTR)	20/04/2006	06/03/2006	International Collaborative Infantile Spasms Study (ICISS) - ICISS	International Collaborative Infantile Spasms Study (ICISS) - ICISS	Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually und ...	Trade Name: SABRILSACHETS INN or Proposed INN: Vigabatrin Trade Name: SYNACTHEN DEPOT INN or Proposed I ...	Royal United Hospital Bath NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	410	Phase 4	Germany;United Kingdom
7	EUCTR2021-003015-26-FR (EUCTR)		31/12/2021	Treatment of Infantile Spasms	A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to V ...	Monotherapy for the treatment of infantile spasms (IS) in infants and children2 months to 24 months ...	Product Name: AMZ002 Product Code: AMZ002 INN or Proposed INN: Vigabatrin Trade Name: Sabril Product Nam ...	Amzell B.V.	NULL	NA			Female: yes Male: yes	230	Phase 3	United States;France;Spain;Poland;Germany
8	EUCTR2014-000360-17-FR (EUCTR)		17/06/2015	Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile sp ...	Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile sp ...	Infantile spasms and pharmaco-resistant partial epilepsy MedDRA version: 18.0;Level: PT;Classificati ...	Product Name: vigabatrin Product Code: VGB-ST INN or Proposed INN: VIGABATRIN Other descriptive name: V ...	TARGEON	NULL	NA			Female: yes Male: yes		Phase 2	France

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158. 結節性硬化症

臨床試験数 : 112 / 薬物数 : 71 - (DrugBank : 19) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118

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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	EUCTR2013-005528-40-BE (EUCTR)	11/12/2014	17/11/2014	Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a ge ...	Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a ge ...	epilepsy in tuberous sclerosis complex (TSC);Therapeutic area: Diseases [C] - Nervous System Disease ...	Trade Name: vigabatrin (sabril) Product Name: vigabatrin INN or Proposed INN: VIGABATRIN	Vrije Universiteit Brussel	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Belgium;Netherlands
2	EUCTR2013-005528-40-NL (EUCTR)	05/12/2014	14/07/2014	Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a ge ...	Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a ge ...	Epilepsy in tuberous sclerosis complex (TSC) MedDRA version: 17.0;Level: LLT;Classification code 100 ...	Trade Name: Vigabatrin (Sabril) Product Name: vigabatrin	The Children's Memorial Health Institute	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Belgium;Netherlands
3	NCT01266291 (ClinicalTrials.gov)	August 2010	22/12/2010	Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients	Sabrilfor Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open ...	Complex Partial Seizures	Drug: vigabatrin	University of Pennsylvania	H. Lundbeck A/S	Terminated	18 Years	N/A	All	1	Phase 4	United States
4	EUCTR2020-003231-19-PL (EUCTR)		09/10/2020	Comparison of the efficacy and safety of rapamycin versus vigabatrin in the prevention of Tuberous S ...	Randomized, placebo-controlled, double-blind and double-dummy clinical trial comparing the safety, t ...	Tuberous Sclerosis ComplexEpilepsyTumors associated with Tuberous Sclerosis Complex;Therapeutic area ...	Trade Name: SABRIL 500 mg, granules for oral solution Trade Name: RAPAMUNE 1 mg/ml oral solution	The Children's Memorial Health Institute	NULL	NA			Female: yes Male: yes	60	Phase 2;Phase 3	Poland

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