140. ドラベ症候群 Dorabe syndrome Clinical trials / Disease details
臨床試験数 : 116 / 薬物数 : 65 - (DrugBank : 17) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 64
| 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 | EUCTR2019-001331-31-IT (EUCTR) | 18/12/2019 | 17/06/2021 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With EpilepticEncephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy forSeizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome - - | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramina cloridrato Product Code: [ZX008] INN or Proposed INN: Fenfluramina cloridrato Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 2 | EUCTR2015-004167-37-IT (EUCTR) | 17/05/2016 | 15/11/2018 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome - Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and yo | Dravet syndrome MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramina Cloridrato Product Code: ZX008 INN or Proposed INN: Fenfluramina Cloridrato Product Name: Fenfluramina Cloridrato Product Code: ZX008 INN or Proposed INN: Fenfluramina Cloridrato Product Name: Fenfluramina Cloridrato Product Code: ZX008 INN or Proposed INN: Fenfluramina Cloridrato | ZOGENIX INTERNATIONAL LTD | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | France;Spain;Belgium;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Sweden;Korea, Republic of |