VIGABATRIN ( DrugBank: Vigabatrin )

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	17
158	結節性硬化症	6

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	ChiCTR2100045702	2021-04-21	2021-04-23	Observation on the clinical effect of vigabatrinplus vitamin B1 in the treatment of infantile spasms ...	Observation on the clinical effect of vigabatrinplus vitamin B1 in the treatment of infantile spasms ...	infantile spasms	experimental group:Use vitamin B1;control group:Vitamin B1 is not used ;	Faculty of Pediatrics, the first Medical Centre, Chinese PLA General Hospital	NULL	Recruiting			Both	experimental group:10;control group:10;		China
3	NCT04302116 (ClinicalTrials.gov)	May 18, 2020	5/3/2020	Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm	Efficacy of VigabatrinWith High Dose Prednisolone Combination Therapy Versus VigabatrinAlone for Inf ...	Infantile Spasm;West Syndrome	Drug: Combination therapy with vigabatrin and prednisolone;Drug: Vigabatrin Tablets	Kullasate Sakpichaisakul	NULL	Recruiting	2 Months	14 Months	All	250	N/A	Thailand
4	NCT03421496 (ClinicalTrials.gov)	September 5, 2018	26/1/2018	A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatri ...	A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, ...	Infantile Spasm	Drug: Cannabidiol Oral Solution;Drug: Placebo;Drug: Vigabatrin	Benuvia Therapeutics Inc.	NULL	Terminated	1 Month	24 Months	All	2	Phase 3	United States
5	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
6	NCT03347526 (ClinicalTrials.gov)	April 19, 2018	15/11/2017	A Novel Approach to Infantile Spasms	A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigaba ...	Infantile Spasm	Drug: Cosyntropin Injectable Suspension, 1 mg/mL;Drug: Cosyntropin Injectable Suspension 1 MG/ML + v ...	University of Colorado, Denver	Pediatric Epilepsy Research Foundation;West Therapuetics, Inc	Suspended	2 Months	2 Years	All	394	Phase 3	United States
7	NCT02299115 (ClinicalTrials.gov)	September 5, 2017	18/11/2014	Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms	Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms	Infantile Spasms	Drug: Prednisolone;Drug: Vigabatrin	The Hospital for Sick Children	NULL	Withdrawn	2 Months	24 Months	All	0	Phase 3	Canada
8	NCT02220114 (ClinicalTrials.gov)	May 2014	14/8/2014	Acceptability Study of a New Paediatric Form of Vigabatrinin Infants and Children With Infantile Spa ...	Acceptability Study of a New Paediatric Form of Vigabatrinin Infants and Children With Infantile Spa ...	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
9	JPRN-JapicCTI-142559	01/11/2012	02/06/2014	A open-label study of M071754 in patients with infantile spasms	A Long term study of M071754 - A open-label study in patients with infantile spasms -	infantile spasms	Intervention name : M071754 INN of the intervention : vigabatrin Dosage And administration of the inte ...	Alfresa Pharma Corporation	Sanofi KK		0	5	BOTH		Phase 4	NULL
10	JPRN-JapicCTI-142558	01/8/2012		A single-blind study of M071754 in patients with infantile spasms	A Phase III study of M071754 - A single-blind study in patients with infantile spasms -	infantile spasms	Intervention name : M071754 INN of the intervention : vigabatrin Dosage And administration of the inte ...	Alfresa Pharma Corporation	Sanofi KK		0	1	BOTH	12	Phase 3	NULL

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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	NCT04987463 (ClinicalTrials.gov)	May 7, 2021	28/5/2021	Efficacy and Safety of Rapamycin Versus Vigabatrinin the Prevention of Tuberous Sclerosis Complex Sy ...	Randomized, Placebo-controlled, Double-blind and Double-dummy Clinical Trial Comparing the Safety, T ...	Tuberous Sclerosis Complex	Drug: Vigabatrin;Drug: Rapamycin;Drug: Placebo	Katarzyna Kotulska	NULL	Recruiting	4 Weeks	16 Weeks	All	60	Phase 2/Phase 3	Poland
2	NCT02849457 (ClinicalTrials.gov)	December 2016	13/7/2016	Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex	Preventing Epilepsy Using VigabatrinIn Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Ran ...	Tuberous Sclerosis Complex	Drug: Vigabatrin;Drug: Placebo	Martina Bebin	National Institute of Neurological Disorders and Stroke (NINDS)	Active, not recruiting	N/A	6 Months	All	84	Phase 2	United States
3	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
4	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
5	NCT01266291 (ClinicalTrials.gov)	August 2010	22/12/2010	Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients	Sabril for 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
6	EUCTR2020-003231-19-PL (EUCTR)		09/10/2020	Comparison of the efficacy and safety of rapamycin versus vigabatrinin the prevention of Tuberous Sc ...	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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