145. ウエスト症候群 ［臨床試験数：27，薬物数：40（DrugBank：12），標的遺伝子数：21，標的パスウェイ数：19］
Searched query = "West syndrome", "Infantile spasm"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03876444 | April 1, 2019 | 25 March 2019 | Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms | Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial | Infantile Spasm | Drug: Intravenous Methylprednisolone;Drug: Oral Pednisolone | Suvasini Sharma | Not recruiting | 4 Months | 30 Months | All | 128 | Phase 2/Phase 3 | India | |
| 2 | NCT03976076 | March 1, 2019 | 11 November 2019 | A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients | A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and Pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients | Refractory Infantile Spasms | Drug: JBPOS0101 | Bio-Pharm Solutions Co., Ltd. | Recruiting | 6 Months | 24 Months | All | 35 | Phase 2 | United States | |
| 3 | NCT03421496 | September 5, 2018 | 24 June 2019 | 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 | INSYS Therapeutics Inc | Not recruiting | 1 Month | 24 Months | All | 190 | Phase 3 | United States | |
| 4 | EUCTR2017-004775-30-FI | 09/05/2018 | 21 May 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 Pharmaceutical Form: Granules for oral solution INN or Proposed INN: VIGABATRIN CAS Number: 60643-86-9 | Kirsi Mikkonen/Helsinki University Hospital | Authorised | Female: yes Male: yes | 140 | Phase 4 | Finland | |||
| 5 | NCT03347526 | April 19, 2018 | 7 October 2019 | 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 | Not recruiting | 2 Months | 2 Years | All | 394 | Phase 3 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02829827 | December 4, 2017 | 30 September 2019 | A 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) | Drug: Radiprodil | UCB Biopharma S.P.R.L. | Not recruiting | 2 Months | 14 Months | All | 3 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom | |
| 7 | NCT02299115 | September 5, 2017 | 11 June 2018 | 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 | Recruiting | 2 Months | 24 Months | All | 105 | Phase 3 | Canada | |
| 8 | NCT02954887 | May 9, 2017 | 23 July 2018 | Phase 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 Study | Infantile Spasms | Drug: GWP42003-P | GW Research Ltd | Not recruiting | 1 Month | 24 Months | All | 202 | Phase 3 | United States;Poland | |
| 9 | NCT02953548 | March 16, 2017 | 20 August 2018 | Trial 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 Study | Infantile Spasms | Drug: GWP42003-P | GW Research Ltd | Not recruiting | 1 Month | 24 Months | All | 10 | Phase 3 | United States;Poland | |
| 10 | NCT02220114 | May 2014 | 11 June 2018 | 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® | Targeon SAS | Institut National de la Santé Et de la Recherche Médicale, France;Hospices Civils de Lyon;National Research Agency, France | Not recruiting | 1 Month | 6 Years | All | 38 | N/A | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2014-000360-17-FR | 2 October 2017 | 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 Pharmaceutical Form: Soluble tablet INN or Proposed INN: VIGABATRIN CAS Number: 60643-86-9 Current Sponsor code: VGB-ST Other descriptive name: VGB-ST soluble tablets Concentration unit: mg milligram(s) Concentration type: range Concentration number: 100-500 Trade Name: Sabril granules for oral use Pharmaceutical Form: Granules for oral solution in sachet | TARGEON | Not Available | Female: yes Male: yes | Phase 2 | France | |||||
| 12 | NCT02092883 | March 2013 | 16 December 2017 | Evaluation of Neuroinflammation in Children With Infantile Spasms | Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH | Infantile Spasms | Drug: ACTH | Wayne State University | Not recruiting | N/A | N/A | All | 8 | Phase 4 | United States | |
| 13 | JPRN-JapicCTI-142559 | 01/11/2012 | 23 April 2019 | 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 | |||
| 14 | NCT01828437 | November 2012 | 28 January 2019 | Addition of Pyridoxine to Prednisolone in Infantile Spasms | Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial | Infantile Spasms | Drug: Pyridoxine plus prednisolone;Drug: Prednisolone | Lady Hardinge Medical College | Not recruiting | 3 Months | 36 Months | All | 62 | Phase 3 | India | |
| 15 | JPRN-JapicCTI-142558 | 01/8/2012 | 2 April 2019 | 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 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT01413711 | June 2012 | 19 February 2015 | 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 | Not recruiting | 1 Month | 6 Months | Both | 0 | Phase 4 | ||
| 17 | NCT01575639 | February 2012 | 19 February 2015 | Prednisolone in Infantile Spasms- High Dose Versus Usual Dose | Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms. | Infantile Spasms;West Syndrome | Drug: Oral prednisolone | Lady Hardinge Medical College | Not recruiting | 3 Months | 24 Months | Both | 63 | Phase 3 | India | |
| 18 | NCT01367964 | July 2011 | 26 November 2018 | Prevention 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 Syndrome | Drug: adrenocorticotropin hormone | Ann & Robert H Lurie Children's Hospital of Chicago | Thrasher Research Fund | Not recruiting | 2 Months | 12 Months | All | 28 | N/A | United States |
| 19 | EUCTR2006-000788-27-DE | 23/09/2010 | 5 June 2018 | 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 Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Vigabatrin CAS Number: 60643-86-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: Synacthen Depot Pharmaceutical Form: Injection INN or Proposed INN: Tetracosactide Acetate CAS Number: 16960-16-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Trade Name: Decortin H Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 125-02-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- | Royal United Hospital Bath NHS Trust | Not Recruiting | Female: yes Male: yes | 410 | Phase 4 | Australia;Germany;United Kingdom;Switzerland;New Zealand | |||
| 20 | NCT01006811 | October 2009 | 19 February 2015 | Use of the Modified Atkins Diet in Infantile Spasms | Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study. | Infantile Spasms | Dietary Supplement: modified Atkins diet;Other: modified Atkins diet | All India Institute of Medical Sciences, New Delhi | Not recruiting | 6 Months | 3 Years | Both | 15 | Phase 2/Phase 3 | India | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT01073579 | August 2009 | 8 August 2016 | Sabril Patient Registry | Sabril Patient Registry | Infantile Spasms;Refractory Complex Partial Seizures in Adults | Drug: Sabril® | Lundbeck LLC | Not recruiting | N/A | N/A | Both | 9423 | N/A | ||
| 22 | EUCTR2006-004285-13-CZ | 11/05/2007 | 19 March 2012 | 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. | 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 Pharmaceutical Form: Oral suspension CAS Number: 38398-32-2 Current Sponsor code: CCD 1042 Other descriptive name: Ganaxolone Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 3 mg/kg -18 mg/kg Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use | Marinus Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 54 | Czech Republic | ||||
| 23 | EUCTR2006-004286-33-CZ | 11/05/2007 | 19 March 2012 | An 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 Pharmaceutical Form: Oral suspension CAS Number: 38398-32-2 Current Sponsor code: CCD 1042 Other descriptive name: Ganaxolone Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 3 mg/kg-18 mg/kg | Marinus Pharmceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 54 | Czech Republic | ||||
| 24 | NCT00441896 | January 2007 | 19 February 2015 | A Randomized, Controlled Trial of Ganaxolone in 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 | Drug: Ganaxolone | Marinus Pharmaceuticals | Not recruiting | 4 Months | 24 Months | Both | 56 | Phase 2 | United States | |
| 25 | NCT00442104 | January 2007 | 19 February 2015 | Open-label Extension to Protocol 1042-0500 | An Open-label Clinical Study to Evaluate the Safety and Antiepileptic Activity of Ganaxolone in Treatment of Patients Diagnosed With Infantile Spasms. | Infantile Spasms | Drug: Ganaxolone | Marinus Pharmaceuticals | Not recruiting | 4 Months | 24 Months | Both | 54 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2006-000788-27-GB | 20/04/2006 | 10 September 2018 | 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 Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Vigabatrin CAS Number: 60643-86-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: SYNACTHEN DEPOT Pharmaceutical Form: Injection* INN or Proposed INN: Tetracosactide Acetate CAS Number: 16960-16-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Trade Name: SOLUBLE PREDNISOLONE TABLETS Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 125-02-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- | Royal United Hospital Bath NHS Trust | Not Recruiting | Female: yes Male: yes | 410 | Phase 4 | Germany;United Kingdom | |||
| 27 | NCT00001325 | April 1992 | 19 February 2015 | Metabolic Abnormalities in Children With Epilepsy | Natural History of Metabolic Abnormalities in Children With Epilepsy | Generalized Epilepsy;Infantile Spasms;Metabolic Disease;Partial Epilepsy;Seizures | Drug: 18 FDG | National Institute of Neurological Disorders and Stroke (NINDS) | Not recruiting | N/A | N/A | Both | 80 | N/A | United States |