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 145. ウエスト症候群 [臨床試験数:27,薬物数:40(DrugBank:12),標的遺伝子数:21,標的パスウェイ数:4] 

Searched query = "West syndrome", "Infantile spasm"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03876444April 1, 201925 March 2019Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile SpasmsIntravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled TrialInfantile SpasmDrug: Intravenous Methylprednisolone;Drug: Oral PednisoloneSuvasini SharmaNot recruiting4 Months30 MonthsAll128Phase 2/Phase 3India
2NCT03976076March 1, 201911 November 2019A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms PatientsA Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and Pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms PatientsRefractory Infantile SpasmsDrug: JBPOS0101Bio-Pharm Solutions Co., Ltd.Recruiting6 Months24 MonthsAll35Phase 2United States
3NCT03421496September 5, 201824 June 2019A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile SpasmsA Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile SpasmsInfantile SpasmDrug: Cannabidiol Oral Solution;Drug: Placebo;Drug: VigabatrinINSYS Therapeutics IncNot recruiting1 Month24 MonthsAll190Phase 3United States
4EUCTR2017-004775-30-FI09/05/201821 May 2018PREDICTION AND PREVENTION OF INFANTILE SPASM SYNDROME IN HIGH RISK CHILDRENPREDICTION AND PREVENTION OF INFANTILE SPASMS IN HIGH RISK CHILDREN - PREV-ISTherapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Sabrilex
Product Name: Sabrilex
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: VIGABATRIN
CAS Number: 60643-86-9
Kirsi Mikkonen/Helsinki University HospitalAuthorisedFemale: yes
Male: yes
140Phase 4Finland
5NCT03347526April 19, 20187 October 2019A Novel Approach to Infantile SpasmsA Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction TherapyInfantile SpasmDrug: Cosyntropin Injectable Suspension, 1 mg/mL;Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin;Drug: VigabatrinUniversity of Colorado, DenverPediatric Epilepsy Research Foundation;West Therapuetics, IncNot recruiting2 Months2 YearsAll394Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02829827December 4, 201730 September 2019A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)An Open-label Adaptive Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Radiprodil in Subjects With Drug-resistant Infantile SpasmsInfantile Spasms (IS)Drug: RadiprodilUCB Biopharma S.P.R.L.Not recruiting2 Months14 MonthsAll3Phase 2France;Belgium;Bulgaria;Germany;United Kingdom
7NCT02299115September 5, 201711 June 2018Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile SpasmsPrednisolone vs. Vigabatrin in the First-line Treatment of Infantile SpasmsInfantile SpasmsDrug: Prednisolone;Drug: VigabatrinThe Hospital for Sick ChildrenRecruiting2 Months24 MonthsAll105Phase 3Canada
8NCT02954887May 9, 201723 July 2018Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot StudyInfantile SpasmsDrug: GWP42003-PGW Research LtdNot recruiting1 Month24 MonthsAll202Phase 3United States;Poland
9NCT02953548March 16, 201720 August 2018Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot StudyInfantile SpasmsDrug: GWP42003-PGW Research LtdNot recruiting1 Month24 MonthsAll10Phase 3United States;Poland
10NCT02220114May 201411 June 2018Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial EpilepsyAcceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized StudyInfantile SpasmsDrug: Vigabatrin: Vigabatrin new ST formulation then Sabril®Targeon SASInstitut National de la Santé Et de la Recherche Médicale, France;Hospices Civils de Lyon;National Research Agency, FranceNot recruiting1 Month6 YearsAll38N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2014-000360-17-FR2 October 2017Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy.Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy. Observational, descriptive, open-label, multi-centric, non-randomized study - SOLUWESTInfantile spasms and pharmaco-resistant partial epilepsy
MedDRA version: 18.0 Level: PT Classification code 10021750 Term: Infantile spasms System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0 Level: LLT Classification code 10065336 Term: Partial epilepsy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: vigabatrin
Product Code: VGB-ST
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: VIGABATRIN
CAS Number: 60643-86-9
Current Sponsor code: VGB-ST
Other descriptive name: VGB-ST soluble tablets
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 100-500
Trade Name: Sabril granules for oral use
Pharmaceutical Form: Granules for oral solution in sachet
TARGEONNot AvailableFemale: yes
Male: yes
Phase 2France
12NCT02092883March 201316 December 2017Evaluation of Neuroinflammation in Children With Infantile SpasmsNeuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTHInfantile SpasmsDrug: ACTHWayne State UniversityNot recruitingN/AN/AAll8Phase 4United States
13JPRN-JapicCTI-14255901/11/201223 April 2019A open-label study of M071754 in patients with infantile spasmsA Long term study of M071754 - A open-label study in patients with infantile spasms -infantile spasmsIntervention name : M071754
INN of the intervention : vigabatrin
Dosage And administration of the intervention : oral
Alfresa Pharma CorporationSanofi KK05BOTHPhase 4
14NCT01828437November 201228 January 2019Addition of Pyridoxine to Prednisolone in Infantile SpasmsAddition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled TrialInfantile SpasmsDrug: Pyridoxine plus prednisolone;Drug: PrednisoloneLady Hardinge Medical CollegeNot recruiting3 Months36 MonthsAll62Phase 3India
15JPRN-JapicCTI-14255801/8/20122 April 2019A single-blind study of M071754 in patients with infantile spasmsA Phase III study of M071754 - A single-blind study in patients with infantile spasms -infantile spasmsIntervention name : M071754
INN of the intervention : vigabatrin
Dosage And administration of the intervention : oral
Control intervention name : null
Alfresa Pharma CorporationSanofi KK01BOTH12Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01413711June 201219 February 2015An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile SpasmsAn Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile SpasmsInfantile SpasmsDrug: VigabatrinLundbeck LLCNot recruiting1 Month6 MonthsBoth0Phase 4
17NCT01575639February 201219 February 2015Prednisolone in Infantile Spasms- High Dose Versus Usual DoseRandomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.Infantile Spasms;West SyndromeDrug: Oral prednisoloneLady Hardinge Medical CollegeNot recruiting3 Months24 MonthsBoth63Phase 3India
18NCT01367964July 201126 November 2018Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)West SyndromeDrug: adrenocorticotropin hormoneAnn & Robert H Lurie Children's Hospital of ChicagoThrasher Research FundNot recruiting2 Months12 MonthsAll28N/AUnited States
19EUCTR2006-000788-27-DE23/09/20105 June 2018International Collaborative Study of a type of epilepsy called Infantile SpasmsInternational Collaborative Infantile Spasms Study (ICISS) - ICISSInfantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: SABRIL
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Vigabatrin
CAS Number: 60643-86-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: Synacthen Depot
Pharmaceutical Form: Injection
INN or Proposed INN: Tetracosactide Acetate
CAS Number: 16960-16-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Trade Name: Decortin H
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 125-02-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Royal United Hospital Bath NHS TrustNot RecruitingFemale: yes
Male: yes
410Phase 4Australia;Germany;United Kingdom;Switzerland;New Zealand
20NCT01006811October 200919 February 2015Use of the Modified Atkins Diet in Infantile SpasmsEfficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.Infantile SpasmsDietary Supplement: modified Atkins diet;Other: modified Atkins dietAll India Institute of Medical Sciences, New DelhiNot recruiting6 Months3 YearsBoth15Phase 2/Phase 3India
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01073579August 20098 August 2016Sabril Patient RegistrySabril Patient RegistryInfantile Spasms;Refractory Complex Partial Seizures in AdultsDrug: Sabril®Lundbeck LLCNot recruitingN/AN/ABoth9423N/A
22EUCTR2006-004285-13-CZ11/05/200719 March 2012A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability, and antiepileptic activity of ganaxolone in treatment of patients with infantile spasms.A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability, and antiepileptic activity of ganaxolone in treatment of patients with infantile spasms.Infantile spasms
MedDRA version: 9.1 Level: LLT Classification code 10021750 Term: Infantile spasms
Product Name: Ganaxolone
Pharmaceutical Form: Oral suspension
CAS Number: 38398-32-2
Current Sponsor code: CCD 1042
Other descriptive name: Ganaxolone
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 3 mg/kg -18 mg/kg
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Marinus Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
54Czech Republic
23EUCTR2006-004286-33-CZ11/05/200719 March 2012An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spasms.An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spasms.Infantile spasms
MedDRA version: 9.1 Level: LLT Classification code 10021750 Term: Infantile spasms
Product Name: Ganaxolone
Product Code: SPT3162
Pharmaceutical Form: Oral suspension
CAS Number: 38398-32-2
Current Sponsor code: CCD 1042
Other descriptive name: Ganaxolone
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 3 mg/kg-18 mg/kg
Marinus Pharmceuticals, Inc.Not RecruitingFemale: yes
Male: yes
54Czech Republic
24NCT00441896January 200719 February 2015A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile SpasmsA Double-blind, Placebo-controlled, Dose-ranging Clinical Study to Evaluate the Safety, Tolerability, and Antiepileptic Activity of Ganaxolone in Treatment of Patients With Infantile SpasmsInfantile SpasmsDrug: GanaxoloneMarinus PharmaceuticalsNot recruiting4 Months24 MonthsBoth56Phase 2United States
25NCT00442104January 200719 February 2015Open-label Extension to Protocol 1042-0500An Open-label Clinical Study to Evaluate the Safety and Antiepileptic Activity of Ganaxolone in Treatment of Patients Diagnosed With Infantile Spasms.Infantile SpasmsDrug: GanaxoloneMarinus PharmaceuticalsNot recruiting4 Months24 MonthsBoth54Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-000788-27-GB20/04/200610 September 2018International Collaborative Infantile Spasms Study (ICISS) - ICISSInternational Collaborative Infantile Spasms Study (ICISS) - ICISSInfantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder.Trade Name: SABRIL SACHETS
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Vigabatrin
CAS Number: 60643-86-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: SYNACTHEN DEPOT
Pharmaceutical Form: Injection*
INN or Proposed INN: Tetracosactide Acetate
CAS Number: 16960-16-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Trade Name: SOLUBLE PREDNISOLONE TABLETS
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 125-02-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Royal United Hospital Bath NHS TrustNot RecruitingFemale: yes
Male: yes
410Phase 4Germany;United Kingdom
27NCT00001325April 199219 February 2015Metabolic Abnormalities in Children With EpilepsyNatural History of Metabolic Abnormalities in Children With EpilepsyGeneralized Epilepsy;Infantile Spasms;Metabolic Disease;Partial Epilepsy;SeizuresDrug: 18 FDGNational Institute of Neurological Disorders and Stroke (NINDS)Not recruitingN/AN/ABoth80N/AUnited States

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