Vigabatrin    (DrugBank: Vigabatrin)

2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
145ウエスト症候群14
158結節性硬化症4

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.
14 / 39 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Status
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agemin
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agemax
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PhaseCountries
1NCT04302116
(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
2NCT03421496
(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
3EUCTR2017-004775-30-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
4NCT03347526
(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
5NCT02299115
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02220114
(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
7JPRN-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
8JPRN-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
9NCT01413711
(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
10EUCTR2006-000788-27-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
11EUCTR2006-000788-27-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
12EUCTR2017-000611-17-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
13EUCTR2017-000230-62-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
14EUCTR2014-000360-17-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

158. 結節性硬化症 [臨床試験数:100,薬物数:62(DrugBank:16),標的遺伝子数:35,標的パスウェイ数:115
Searched query = "Tuberous sclerosis", "Tuberous sclerosis complex"
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.
4 / 100 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02849457
(ClinicalTrials.gov)
December 201613/7/2016Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis ComplexPreventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSCTuberous Sclerosis ComplexDrug: Vigabatrin;Drug: PlaceboMartina BebinNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruitingN/A6 MonthsAll84Phase 2United States
2EUCTR2013-005528-40-BE
(EUCTR)
11/12/201417/11/2014Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complexLong-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex - EPISTOP epilepsy in tuberous sclerosis complex (TSC);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: vigabatrin (sabril)
Product Name: vigabatrin
INN or Proposed INN: VIGABATRIN
Vrije Universiteit BrusselNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Belgium;Netherlands
3EUCTR2013-005528-40-NL
(EUCTR)
05/12/201414/07/2014Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex.Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex. - EPISTOP Epilepsy in tuberous sclerosis complex (TSC)
MedDRA version: 17.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Vigabatrin (Sabril)
Product Name: vigabatrin
The Children's Memorial Health InstituteNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Belgium;Netherlands
4NCT01266291
(ClinicalTrials.gov)
August 201022/12/2010Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) PatientsSabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability StudyComplex Partial SeizuresDrug: vigabatrinUniversity of PennsylvaniaH. Lundbeck A/STerminated18 YearsN/AAll1Phase 4United States