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
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | 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 vigabatrin plus 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 | 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 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 | 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 | Infantile Spasm | Drug: Cosyntropin Injectable Suspension, 1 mg/mL;Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin;Drug: Vigabatrin | 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 Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study | 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 | 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 | 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 | Alfresa Pharma Corporation | Sanofi KK | 0 | 1 | BOTH | 12 | Phase 3 | NULL | ||
| 11 | NCT01413711 (ClinicalTrials.gov) | June 2012 | 17/6/2011 | An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms | An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms | Infantile Spasms | Drug: Vigabatrin | Lundbeck LLC | NULL | Withdrawn | 1 Month | 6 Months | Both | 0 | Phase 4 | NULL |
| 12 | EUCTR2006-000788-27-DE (EUCTR) | 23/09/2010 | 11/06/2010 | International Collaborative Study of a type of epilepsy called Infantile Spasms | International 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 410 | Phase 4 | Australia;Germany;United Kingdom;Switzerland;New Zealand | ||
| 13 | EUCTR2006-000788-27-GB (EUCTR) | 20/04/2006 | 06/03/2006 | International Collaborative Infantile Spasms Study (ICISS) - ICISS | International 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 410 | Phase 4 | Germany;United Kingdom | ||
| 14 | EUCTR2021-003015-26-FR (EUCTR) | 31/12/2021 | 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 | 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. | NULL | NA | Female: yes Male: yes | 230 | Phase 3 | United States;France;Spain;Poland;Germany | |||
| 15 | EUCTR2014-000360-17-FR (EUCTR) | 17/06/2015 | Acceptability 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 | TARGEON | NULL | NA | Female: yes Male: yes | Phase 2 | France | ||||
| 16 | EUCTR2017-000230-62-Outside-EU/EEA (EUCTR) | 24/04/2017 | 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. - | 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 KK | NULL | NA | Female: yes Male: yes | 12 | Phase 3 | Japan | |||
| 17 | EUCTR2017-000611-17-Outside-EU/EEA (EUCTR) | 28/08/2017 | 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. | 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 KK | NULL | NA | Female: yes Male: yes | 17 | Phase 3 | Japan |