Sabril ( DrugBank: - )
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 | 8 |
| 158 | 結節性硬化症 | 4 |
145. ウエスト症候群
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 | 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 | ||
| 3 | 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 |
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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 | ||
| 7 | 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 | |||
| 8 | 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 |
158. 結節性硬化症
臨床試験数 : 112 / 薬物数 : 71 - (DrugBank : 19) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118
| 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 | EUCTR2013-005528-40-BE (EUCTR) | 11/12/2014 | 17/11/2014 | Long-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);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: vigabatrin (sabril) Product Name: vigabatrin INN or Proposed INN: VIGABATRIN | Vrije Universiteit Brussel | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Belgium;Netherlands | |||
| 2 | EUCTR2013-005528-40-NL (EUCTR) | 05/12/2014 | 14/07/2014 | Long-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 Institute | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Belgium;Netherlands | |||
| 3 | NCT01266291 (ClinicalTrials.gov) | August 2010 | 22/12/2010 | Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients | Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study | Complex Partial Seizures | Drug: vigabatrin | University of Pennsylvania | H. Lundbeck A/S | Terminated | 18 Years | N/A | All | 1 | Phase 4 | United States |
| 4 | EUCTR2020-003231-19-PL (EUCTR) | 09/10/2020 | Comparison of the efficacy and safety of rapamycin versus vigabatrin in the prevention of Tuberous Sclerosis Complex symptoms in infants in the randomized clinical trial | Randomized, placebo-controlled, double-blind and double-dummy clinical trial comparing the safety, tolerability, and efficacy of vigabatrin and rapamycin in a preventive treatment of infants with Tuberous Sclerosis Complex (ViRap) - ViRap | Tuberous Sclerosis ComplexEpilepsyTumors associated with Tuberous Sclerosis Complex;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SABRIL 500 mg, granules for oral solution Trade Name: RAPAMUNE 1 mg/ml oral solution | The Children's Memorial Health Institute | NULL | NA | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Poland |