145. ウエスト症候群 West syndrome Clinical trials / Disease details
臨床試験数 : 43 / 薬物数 : 52 - (DrugBank : 15) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 26
Showing 1 to 10 of 17 diseases
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | EUCTR2021-003015-26-ES (EUCTR) | 12/04/2022 | 25/10/2021 | Treatment of Infantile Spasms | A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to V ... | 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] Monotherapy for the treatment of infantile spasms (IS) in infants and children2 months to 24 months ... | 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 Product Name: AMZ002 Product Code: AMZ002 INN or Proposed INN: Vigabatrin Trade Name: Sabril Product Nam ... | Amzell B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | France;United States;Poland;Spain | ||
2 | ChiCTR2100045702 | 2021-04-21 | 2021-04-23 | Observation on the clinical effect of vigabatrin plus vitamin B1 in the treatment of infantile spasms Observation on the clinical effect of vigabatrinplus vitamin B1 in the treatment of infantile spasms ... | Observation on the clinical effect of vigabatrin plus vitamin B1 in the treatment of infantile spasms Observation on the clinical effect of vigabatrinplus vitamin B1 in the treatment of infantile spasms ... | infantile spasms | experimental group:Use vitamin B1;control group:Vitamin B1 is not used ; | Faculty of Pediatrics, the first Medical Centre, Chinese PLA General Hospital | NULL | Recruiting | Both | experimental group:10;control group:10; | China | |||
3 | NCT04302116 (ClinicalTrials.gov) | May 18, 2020 | 5/3/2020 | Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm | Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial Efficacy of VigabatrinWith High Dose Prednisolone Combination Therapy Versus VigabatrinAlone for Inf ... | Infantile Spasm;West Syndrome | Drug: Combination therapy with vigabatrin and prednisolone;Drug: Vigabatrin Tablets | Kullasate Sakpichaisakul | NULL | Recruiting | 2 Months | 14 Months | All | 250 | N/A | Thailand |
4 | NCT03421496 (ClinicalTrials.gov) | September 5, 2018 | 26/1/2018 | A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatri ... | A 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 Spasms A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, ... | Infantile Spasm | Drug: Cannabidiol Oral Solution;Drug: Placebo;Drug: Vigabatrin | Benuvia Therapeutics Inc. | NULL | Terminated | 1 Month | 24 Months | All | 2 | Phase 3 | United States |
5 | EUCTR2017-004775-30-FI (EUCTR) | 09/05/2018 | 08/05/2018 | PREDICTION AND PREVENTION OF INFANTILE SPASM SYNDROME IN HIGH RISK CHILDREN | PREDICTION 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 Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 4 | Finland | ||
6 | NCT03347526 (ClinicalTrials.gov) | April 19, 2018 | 15/11/2017 | A Novel Approach to Infantile Spasms | A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigaba ... | Infantile Spasm | Drug: Cosyntropin Injectable Suspension, 1 mg/mL;Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin;Drug: Vigabatrin Drug: CosyntropinInjectable Suspension, 1 mg/mL;Drug: CosyntropinInjectable Suspension 1 MG/ML + vig ... | University of Colorado, Denver | Pediatric Epilepsy Research Foundation;West Therapuetics, Inc | Suspended | 2 Months | 2 Years | All | 394 | Phase 3 | United States |
7 | NCT02299115 (ClinicalTrials.gov) | September 5, 2017 | 18/11/2014 | Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms | Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms | Infantile Spasms | Drug: Prednisolone;Drug: Vigabatrin | The Hospital for Sick Children | NULL | Withdrawn | 2 Months | 24 Months | All | 0 | Phase 3 | Canada |
8 | NCT02220114 (ClinicalTrials.gov) | May 2014 | 14/8/2014 | Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy Acceptability Study of a New Paediatric Form of Vigabatrinin Infants and Children With Infantile Spa ... | Acceptability 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 Study Acceptability Study of a New Paediatric Form of Vigabatrinin Infants and Children With Infantile Spa ... | Infantile Spasms | Drug: Vigabatrin: Vigabatrin new ST formulation then Sabril® | Orphelia Pharma | Institut National de la Santé Et de la Recherche Médicale, France;Hospices Civils de Lyon;National Research Agency, France Institut National de la Santé Et de la Recherche Médicale, France;Hospices Civils de Lyon;National R ... | Completed | 1 Month | 6 Years | All | 38 | N/A | France |
9 | JPRN-JapicCTI-142559 | 01/11/2012 | 02/06/2014 | A 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 - | infantile spasms | Intervention name : M071754 INN of the intervention : vigabatrin Dosage And administration of the intervention : oral Intervention name : M071754 INN of the intervention : vigabatrin Dosage And administration of the inte ... | Alfresa Pharma Corporation | Sanofi KK | 0 | 5 | BOTH | Phase 4 | NULL | ||
10 | JPRN-JapicCTI-142558 | 01/8/2012 | A 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 - | infantile spasms | Intervention name : M071754 INN of the intervention : vigabatrin Dosage And administration of the intervention : oral Control intervention name : null Intervention name : M071754 INN of the intervention : vigabatrin Dosage And administration of the inte ... | Alfresa Pharma Corporation | Sanofi KK | 0 | 1 | BOTH | 12 | Phase 3 | NULL |