145. ウエスト症候群 [臨床試験数:39,薬物数:50(DrugBank:13),標的遺伝子数:27,標的パスウェイ数:24

Searched query = "West syndrome", "Infantile spasm"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000036208
2020-09-012020-08-21A randomized controlled clinical study of melatonin in the adjuvant therapy of infantile spasmClinical study of melatonin in the adjuvant therapy of infantile spasm 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 ChinaNULLRecruiting02Bothmelatonin group:50;placebo group:50;China
2NCT04302116
(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
3NCT04289467
(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
4NCT03876444
(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
5NCT03976076
(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 Months24 MonthsAll35Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03421496
(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
7EUCTR2017-004775-30-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
8NCT03347526
(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
9NCT02829827
(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
10EUCTR2016-002107-26-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02299115
(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
12EUCTR2016-002107-26-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]
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
13EUCTR2016-002107-26-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]
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
14NCT02954887
(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
15NCT02953548
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-002107-26-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
17EUCTR2016-002107-26-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
18NCT02220114
(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
19NCT02092883
(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
20JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01828437
(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
22JPRN-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
23NCT01413711
(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
24NCT01575639
(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
25NCT01367964
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-000788-27-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
27NCT01006811
(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
28NCT01073579
(ClinicalTrials.gov)
August 200922/2/2010Sabril Patient RegistrySabril Patient RegistryInfantile Spasms;Refractory Complex Partial Seizures in AdultsDrug: Sabril®Lundbeck LLCNULLCompletedN/AN/ABoth9423N/ANULL
29EUCTR2006-004286-33-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
30EUCTR2006-004285-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00441896
(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
32NCT00442104
(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
33EUCTR2006-000788-27-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
34NCT00001325
(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
35EUCTR2015-004904-50-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]
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2006-004286-33-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
37EUCTR2014-000360-17-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
38EUCTR2017-000611-17-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
39EUCTR2017-000230-62-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