145. West syndrome Clinical trials / Disease details


Clinical trials : 43 Drugs : 54 - (DrugBank : 15) / Drug target genes : 27 - Drug target pathways : 24

  
16 trials found
No.TrialIDDate_
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PhaseCountries
1ChiCTR2100045702
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
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
3NCT03421496
(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
4EUCTR2017-004775-30-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
5NCT03347526
(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
6NCT02299115
(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
7NCT02220114
(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
8JPRN-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
9JPRN-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
10NCT01413711
(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
11EUCTR2006-000788-27-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
12EUCTR2006-000788-27-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
13EUCTR2014-000360-17-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
14EUCTR2017-000230-62-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
15EUCTR2021-003015-26-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
16EUCTR2017-000611-17-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