145. ウエスト症候群 West syndrome Clinical trials / Disease details

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	NCT05279118 (ClinicalTrials.gov)	March 1, 2022	3/3/2022	Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome	Comparison of Efficacy of Ketogenic Diet and ACTH Therapy Among Children With West Syndrome: A Pilot ...	Ketogenic Diet;West Syndrome;Infantile Spasm;ACTH	Dietary Supplement: Ketogenic diet;Drug: ACTH	All India Institute of Medical Sciences, New Delhi	NULL	Recruiting	6 Months	2 Years	All	80	Phase 2/Phase 3	India
3	NCT04727970 (ClinicalTrials.gov)	November 1, 2021	19/1/2021	Tricaprilin Infantile Spasms Pilot Study	A Phase I Open-Label Pilot Study to Investigate the Feasibility, Safety, Tolerability and Efficacy o ...	Infantile Spasm	Drug: Tricaprilin	Cerecin	NULL	Recruiting	3 Months	24 Months	All	10	Phase 1	Australia;Singapore
4	ChiCTR2100045702	2021-04-21	2021-04-23	Observation on the clinical effect of vigabatrin plus vitamin B1 in the treatment of infantile spasm ...	Observation on the clinical effect of vigabatrin plus vitamin B1 in the treatment of infantile spasm ...	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
5	ChiCTR2000036208	2020-10-31	2020-08-21	Melatonin as add-on treatment for infantile spasms	Melatonin supplementation in the treatment of infantile spasms: a randomized placebo-controlled trip ...	Infantile spasm	melatonin group:add melatonin;placebo group:add placebo;	Department of Pediatrics, The First Medical Center, General Hospital of the People's Liberation Army ...	NULL	Recruiting	3?	2	Both	melatonin group:35;placebo group:35;		China
6	NCT04302116 (ClinicalTrials.gov)	May 18, 2020	5/3/2020	Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm	Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for I ...	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
7	NCT04289467 (ClinicalTrials.gov)	April 1, 2020	21/2/2020	Treatment of Refractory Infantile Spasms With Fenfluramine	A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms	Infantile Spasm	Drug: Fenfluramine	University of California, Los Angeles	NULL	Not yet recruiting	3 Months	36 Months	All	10	Phase 2	United States
8	NCT03876444 (ClinicalTrials.gov)	April 1, 2019	12/3/2019	Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms	Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spa ...	Infantile Spasm	Drug: Intravenous Methylprednisolone;Drug: Oral Pednisolone	Suvasini Sharma	NULL	Recruiting	4 Months	30 Months	All	128	Phase 2/Phase 3	India
9	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
10	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

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