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


臨床試験数 : 43 薬物数 : 54 - (DrugBank : 15) / 標的遺伝子数 : 27 - 標的パスウェイ数 : 24

  
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Status
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agemin
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Inclusion_
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PhaseCountries
1NCT05279118
(ClinicalTrials.gov)
March 20223/3/2022Ketogenic Diet vs ACTH for the Treatment of Children With West SyndromeComparison of Efficacy of Ketogenic Diet and ACTH Therapy Among Children With West Syndrome: A Pilot Randomized Control TrialKetogenic Diet;West Syndrome;Infantile Spasm;ACTHDietary Supplement: Ketogenic diet;Drug: ACTHAll India Institute of Medical Sciences, New DelhiNULLNot yet recruiting6 Months2 YearsAll80Phase 2/Phase 3India
2NCT04727970
(ClinicalTrials.gov)
November 1, 202119/1/2021Tricaprilin Infantile Spasms Pilot StudyA Phase I Open-Label Pilot Study to Investigate the Feasibility, Safety, Tolerability and Efficacy of Daily Administration of Tricaprilin in Subjects With Infantile SpasmsInfantile SpasmDrug: TricaprilinCerecinNULLRecruiting3 Months24 MonthsAll10Phase 1Australia;Singapore
3ChiCTR2100045702
2021-04-212021-04-23Observation on the clinical effect of vigabatrin plus vitamin B1 in the treatment of infantile spasmsObservation on the clinical effect of vigabatrin plus vitamin B1 in the treatment of infantile spasms infantile spasmsexperimental group:Use vitamin B1;control group:Vitamin B1 is not used ;Faculty of Pediatrics, the first Medical Centre, Chinese PLA General HospitalNULLRecruitingBothexperimental group:10;control group:10;China
4ChiCTR2000036208
2020-10-312020-08-21Melatonin as add-on treatment for infantile spasmsMelatonin supplementation in the treatment of infantile spasms: a randomized placebo-controlled triple-blind trial Infantile spasmmelatonin group:add melatonin;placebo group:add placebo;Department of Pediatrics, The First Medical Center, General Hospital of the People's Liberation Army of ChinaNULLRecruiting3?2Bothmelatonin group:35;placebo group:35;China
5NCT04302116
(ClinicalTrials.gov)
May 18, 20205/3/2020Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile SpasmEfficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized TrialInfantile Spasm;West SyndromeDrug: Combination therapy with vigabatrin and prednisolone;Drug: Vigabatrin TabletsKullasate SakpichaisakulNULLRecruiting2 Months14 MonthsAll250N/AThailand
6NCT04289467
(ClinicalTrials.gov)
April 1, 202021/2/2020Treatment of Refractory Infantile Spasms With FenfluramineA Phase II Study of Fenfluramine for Treatment of Refractory Infantile SpasmsInfantile SpasmDrug: FenfluramineUniversity of California, Los AngelesNULLNot yet recruiting3 Months36 MonthsAll10Phase 2United States
7NCT03876444
(ClinicalTrials.gov)
April 1, 201912/3/2019Intravenous 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 SharmaNULLRecruiting4 Months30 MonthsAll128Phase 2/Phase 3India
8NCT03976076
(ClinicalTrials.gov)
March 1, 201931/5/2019A 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.NULLRecruiting6 Months36 MonthsAll35Phase 2United States
9NCT03421496
(ClinicalTrials.gov)
September 5, 201826/1/2018A 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: VigabatrinBenuvia Therapeutics Inc.NULLTerminated1 Month24 MonthsAll2Phase 3United States
10EUCTR2017-004775-30-FI
(EUCTR)
09/05/201808/05/2018PREDICTION AND PREVENTION OF INFANTILE SPASM SYNDROME IN HIGH RISK CHILDRENPREDICTION 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 4Finland
11NCT03347526
(ClinicalTrials.gov)
April 19, 201815/11/2017A 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, IncSuspended2 Months2 YearsAll394Phase 3United States
12NCT02829827
(ClinicalTrials.gov)
December 4, 20178/7/2016A 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.NULLTerminated2 Months14 MonthsAll3Phase 2France;Belgium;Bulgaria;Germany;United Kingdom
13EUCTR2016-002107-26-BG
(EUCTR)
10/11/201705/07/2017A 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 SPASMS Infantile spasms (IS)
MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Radiprodil
Product Code: UCB3491
INN or Proposed INN: Radiprodil
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Belgium;Bulgaria;Germany;United Kingdom
14NCT02299115
(ClinicalTrials.gov)
September 5, 201718/11/2014Prednisolone 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 ChildrenNULLWithdrawn2 Months24 MonthsAll0Phase 3Canada
15EUCTR2016-002107-26-DE
(EUCTR)
21/08/201725/04/2017A 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 SPASMS Infantile spasms (IS)
MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Radiprodil
Product Code: UCB3491
INN or Proposed INN: Radiprodil
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Bulgaria;Germany;United Kingdom
16EUCTR2016-002107-26-FR
(EUCTR)
09/06/201710/07/2017A 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 SPASMS Infantile spasms (IS)
MedDRA version: 20.0;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Radiprodil
Product Code: UCB3491
INN or Proposed INN: Radiprodil
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Bulgaria;Germany;United Kingdom
17NCT02954887
(ClinicalTrials.gov)
May 12, 20172/11/2016Phase 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 LtdNULLCompleted1 Month24 MonthsAll9Phase 3United States;Poland
18NCT02953548
(ClinicalTrials.gov)
April 24, 20171/11/2016Trial 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 LtdNULLCompleted1 Month24 MonthsAll9Phase 3United States;Poland
19EUCTR2016-002107-26-BE
(EUCTR)
30/11/201626/09/2016A 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 SPASMS Infantile spasms (IS)
MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Radiprodil
Product Code: UCB3491
INN or Proposed INN: Radiprodil
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Belgium;Bulgaria;Germany;United Kingdom
20EUCTR2016-002107-26-GB
(EUCTR)
24/10/201612/08/2016A 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 SPASMS Infantile spasms (IS)
MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Radiprodil
Product Code: UCB3491
INN or Proposed INN: Radiprodil
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Belgium;Bulgaria;Germany;United Kingdom
21NCT02220114
(ClinicalTrials.gov)
May 201414/8/2014Acceptability 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®Orphelia PharmaInstitut National de la Santé Et de la Recherche Médicale, France;Hospices Civils de Lyon;National Research Agency, FranceCompleted1 Month6 YearsAll38N/AFrance
22NCT02092883
(ClinicalTrials.gov)
March 201314/3/2014Evaluation 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 UniversityNULLCompletedN/AN/AAll8Phase 4United States
23JPRN-JapicCTI-142559
01/11/201202/06/2014A 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 4NULL
24NCT01828437
(ClinicalTrials.gov)
November 20127/4/2013Addition 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 CollegeNULLCompleted3 Months36 MonthsAll62Phase 3India
25JPRN-JapicCTI-142558
01/8/2012A 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 3NULL
26NCT01413711
(ClinicalTrials.gov)
June 201217/6/2011An 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 LLCNULLWithdrawn1 Month6 MonthsBoth0Phase 4NULL
27NCT01575639
(ClinicalTrials.gov)
February 20129/4/2012Prednisolone 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 CollegeNULLCompleted3 Months24 MonthsBoth63Phase 3India
28NCT01367964
(ClinicalTrials.gov)
July 20113/6/2011Prevention 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 FundUnknown status2 Months12 MonthsAll28N/AUnited States
29EUCTR2006-000788-27-DE
(EUCTR)
23/09/201011/06/2010International Collaborative Study of a type of epilepsy called Infantile SpasmsInternational Collaborative Infantile Spasms Study (ICISS) - ICISS Infantile 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
INN or Proposed INN: Vigabatrin
Trade Name: Synacthen Depot
INN or Proposed INN: Tetracosactide Acetate
Trade Name: Decortin H
INN or Proposed INN: Prednisolone
Royal United Hospital Bath NHS TrustNULLNot RecruitingFemale: yes
Male: yes
410Phase 4Australia;Germany;United Kingdom;Switzerland;New Zealand
30NCT01006811
(ClinicalTrials.gov)
October 20091/11/2009Use 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 DelhiNULLCompleted6 Months3 YearsBoth15Phase 2/Phase 3India
31NCT01073579
(ClinicalTrials.gov)
August 200922/2/2010Sabril Patient RegistrySabril Patient RegistryInfantile Spasms;Refractory Complex Partial Seizures in AdultsDrug: Sabril®Lundbeck LLCNULLCompletedN/AN/ABoth9423N/ANULL
32EUCTR2006-004286-33-CZ
(EUCTR)
11/05/200730/03/2007An 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
Other descriptive name: Ganaxolone
Marinus Pharmceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Czech Republic
33EUCTR2006-004285-13-CZ
(EUCTR)
11/05/200730/03/2007A 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
Other descriptive name: Ganaxolone
Marinus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Czech Republic
34NCT00441896
(ClinicalTrials.gov)
January 200727/2/2007A 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: Ganaxolone;Other: PlaceboMarinus PharmaceuticalsNULLCompleted4 Months24 MonthsAll56Phase 2United States
35NCT00442104
(ClinicalTrials.gov)
January 200727/2/2007Open-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 PharmaceuticalsNULLTerminated4 Months24 MonthsAll54Phase 2United States
36EUCTR2006-000788-27-GB
(EUCTR)
20/04/200606/03/2006International Collaborative Infantile Spasms Study (ICISS) - ICISSInternational Collaborative Infantile Spasms Study (ICISS) - ICISS Infantile 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
INN or Proposed INN: Vigabatrin
Trade Name: SYNACTHEN DEPOT
INN or Proposed INN: Tetracosactide Acetate
Trade Name: SOLUBLE PREDNISOLONE TABLETS
INN or Proposed INN: Prednisolone
Royal United Hospital Bath NHS TrustNULLNot RecruitingFemale: yes
Male: yes
410Phase 4Germany;United Kingdom
37NCT00001325
(ClinicalTrials.gov)
April 19923/11/1999Metabolic 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)NULLCompletedN/AN/ABoth80N/AUnited States
38EUCTR2015-004904-50-PL
(EUCTR)
04/04/2017Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile SpasmsA randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study. Infantile Spasms
MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: Cannabidiol
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
202 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Poland;Italy;United Kingdom
39EUCTR2006-004286-33-PL
(EUCTR)
04/06/2007An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spansms.An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spansms. Infantile spasms
MedDRA version: 9.1;Level: LLT;Classification code 10021750;Term: Infantile spasms
Product Name: Ganaxolone
Product Code: SPT3162
Marinus Pharmceuticals, Inc.NULLNAFemale: yes
Male: yes
54Phase 2Czech Republic;Poland
40EUCTR2014-000360-17-FR
(EUCTR)
17/06/2015Acceptability 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 - SOLUWEST Infantile 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
INN or Proposed INN: VIGABATRIN
Other descriptive name: VGB-ST soluble tablets
Trade Name: Sabril granules for oral use
TARGEONNULLNAFemale: yes
Male: yes
Phase 2France
41EUCTR2021-003015-26-FR
(EUCTR)
31/12/2021Treatment of Infantile SpasmsA Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms Monotherapy for the treatment of infantile spasms (IS) in infants and children2 months to 24 months of age
MedDRA version: 21.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10021751;Term: Infantile spasms, with intractable epilepsy;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10021752;Term: Infantile spasms, without mention of intractable epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AMZ002
Product Code: AMZ002
INN or Proposed INN: Vigabatrin
Trade Name: Sabril
Product Name: Sabril
Product Code: Vigabatrin
INN or Proposed INN: Vigabatrin
Amzell B.V.NULLNAFemale: yes
Male: yes
230Phase 3United States;France;Spain;Poland;Germany
42EUCTR2017-000611-17-Outside-EU/EEA
(EUCTR)
28/08/2017A 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. Patients diagnosed with infantile spasms
MedDRA version: 20.0;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: VIGABATRIN
Product Code: M071754
INN or Proposed INN: VIGABATRIN
Alfresa Pharma Corporation and Sanofi KKNULLNAFemale: yes
Male: yes
17Phase 3Japan
43EUCTR2017-000230-62-Outside-EU/EEA
(EUCTR)
24/04/2017A 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. - Patients diagnosed with infantile spasms
MedDRA version: 19.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: VIGABATRIN
Product Code: M071754
INN or Proposed INN: VIGABATRIN
Alfresa Pharma Corporation and Sanofi KKNULLNAFemale: yes
Male: yes
12Phase 3Japan