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 | NCT05279118 (ClinicalTrials.gov) | March 1, 2022 | 3/3/2022 | Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome | Comparison of Efficacy of Ketogenic Diet and ACTH Therapy Among Children With West Syndrome: A Pilot Randomized Control Trial | Ketogenic Diet;West Syndrome;Infantile Spasm;ACTH | Dietary Supplement: Ketogenic diet;Drug: ACTH | All India Institute of Medical Sciences, New Delhi | NULL | Recruiting | 6 Months | 2 Years | All | 80 | Phase 2/Phase 3 | India |
| 3 | NCT04727970 (ClinicalTrials.gov) | November 1, 2021 | 19/1/2021 | Tricaprilin Infantile Spasms Pilot Study | A Phase I Open-Label Pilot Study to Investigate the Feasibility, Safety, Tolerability and Efficacy of Daily Administration of Tricaprilin in Subjects With Infantile Spasms | Infantile Spasm | Drug: Tricaprilin | Cerecin | NULL | Recruiting | 3 Months | 24 Months | All | 10 | Phase 1 | Australia;Singapore |
| 4 | 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 | |||
| 5 | ChiCTR2000036208 | 2020-10-31 | 2020-08-21 | Melatonin as add-on treatment for infantile spasms | Melatonin supplementation in the treatment of infantile spasms: a randomized placebo-controlled triple-blind trial | Infantile spasm | melatonin group:add melatonin;placebo group:add placebo; | Department of Pediatrics, The First Medical Center, General Hospital of the People's Liberation Army of China | NULL | Recruiting | 3? | 2 | Both | melatonin group:35;placebo group:35; | China | |
| 6 | 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 |
| 7 | NCT04289467 (ClinicalTrials.gov) | April 1, 2020 | 21/2/2020 | Treatment of Refractory Infantile Spasms With Fenfluramine | A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms | Infantile Spasm | Drug: Fenfluramine | University of California, Los Angeles | NULL | Not yet recruiting | 3 Months | 36 Months | All | 10 | Phase 2 | United States |
| 8 | NCT03876444 (ClinicalTrials.gov) | April 1, 2019 | 12/3/2019 | 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 | NULL | Recruiting | 4 Months | 30 Months | All | 128 | Phase 2/Phase 3 | India |
| 9 | 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 |
| 10 | 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 | ||
| 11 | 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 |
| 12 | NCT02829827 (ClinicalTrials.gov) | December 4, 2017 | 8/7/2016 | 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. | NULL | Terminated | 2 Months | 14 Months | All | 3 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom |
| 13 | EUCTR2016-002107-26-BG (EUCTR) | 10/11/2017 | 05/07/2017 | 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) MedDRA version: 20.1;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: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 14 | 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 |
| 15 | EUCTR2016-002107-26-DE (EUCTR) | 21/08/2017 | 25/04/2017 | 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) MedDRA version: 20.1;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: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 16 | EUCTR2016-002107-26-FR (EUCTR) | 09/06/2017 | 10/07/2017 | 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) 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: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 17 | NCT02954887 (ClinicalTrials.gov) | May 12, 2017 | 2/11/2016 | 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 | Jazz Pharmaceuticals | NULL | Completed | 1 Month | 24 Months | All | 9 | Phase 3 | United States;Poland |
| 18 | NCT02953548 (ClinicalTrials.gov) | April 24, 2017 | 1/11/2016 | 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 | Jazz Pharmaceuticals | NULL | Completed | 1 Month | 24 Months | All | 9 | Phase 3 | United States;Poland |
| 19 | EUCTR2016-002107-26-BE (EUCTR) | 30/11/2016 | 26/09/2016 | 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) MedDRA version: 20.1;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: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 20 | EUCTR2016-002107-26-GB (EUCTR) | 24/10/2016 | 12/08/2016 | 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) MedDRA version: 20.1;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: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 21 | 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 |
| 22 | NCT02092883 (ClinicalTrials.gov) | March 2013 | 14/3/2014 | 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 | NULL | Completed | N/A | N/A | All | 8 | Phase 4 | United States |
| 23 | 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 | ||
| 24 | NCT01828437 (ClinicalTrials.gov) | November 2012 | 7/4/2013 | 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 | NULL | Completed | 3 Months | 36 Months | All | 62 | Phase 3 | India |
| 25 | 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 | ||
| 26 | 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 |
| 27 | NCT01575639 (ClinicalTrials.gov) | February 2012 | 9/4/2012 | 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 | NULL | Completed | 3 Months | 24 Months | Both | 63 | Phase 3 | India |
| 28 | NCT01367964 (ClinicalTrials.gov) | July 2011 | 3/6/2011 | 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 | Unknown status | 2 Months | 12 Months | All | 28 | N/A | United States |
| 29 | 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 | ||
| 30 | NCT01006811 (ClinicalTrials.gov) | October 2009 | 1/11/2009 | 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 | NULL | Completed | 6 Months | 3 Years | Both | 15 | Phase 2/Phase 3 | India |
| 31 | NCT01073579 (ClinicalTrials.gov) | August 2009 | 22/2/2010 | Sabril Patient Registry | Sabril Patient Registry | Infantile Spasms;Refractory Complex Partial Seizures in Adults | Drug: Sabril® | Lundbeck LLC | NULL | Completed | N/A | N/A | Both | 9423 | N/A | NULL |
| 32 | EUCTR2006-004285-13-CZ (EUCTR) | 11/05/2007 | 30/03/2007 | 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 Other descriptive name: Ganaxolone | Marinus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Czech Republic | |||
| 33 | EUCTR2006-004286-33-CZ (EUCTR) | 11/05/2007 | 30/03/2007 | 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 Other descriptive name: Ganaxolone | Marinus Pharmceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Czech Republic | |||
| 34 | NCT00441896 (ClinicalTrials.gov) | January 2007 | 27/2/2007 | 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;Other: Placebo | Marinus Pharmaceuticals | NULL | Completed | 4 Months | 24 Months | All | 56 | Phase 2 | United States |
| 35 | NCT00442104 (ClinicalTrials.gov) | January 2007 | 27/2/2007 | 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 | NULL | Terminated | 4 Months | 24 Months | All | 54 | Phase 2 | United States |
| 36 | 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 | ||
| 37 | NCT00001325 (ClinicalTrials.gov) | April 1992 | 3/11/1999 | 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) | NULL | Completed | N/A | N/A | Both | 80 | N/A | United States |
| 38 | 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 | |||
| 39 | EUCTR2015-004904-50-PL (EUCTR) | 04/04/2017 | Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms | A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study. | Infantile Spasms MedDRA version: 20.1;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: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: Cannabidiol Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 202 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Poland;Italy;United Kingdom | |||
| 40 | EUCTR2006-004286-33-PL (EUCTR) | 04/06/2007 | An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spansms. | An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spansms. | Infantile spasms MedDRA version: 9.1;Level: LLT;Classification code 10021750;Term: Infantile spasms | Product Name: Ganaxolone Product Code: SPT3162 | Marinus Pharmceuticals, Inc. | NULL | NA | Female: yes Male: yes | 54 | Phase 2 | Czech Republic;Poland | |||
| 41 | 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 | ||||
| 42 | 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 | |||
| 43 | 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 |