140. Dorabe syndrome Clinical trials / Disease details


Clinical trials : 116 Drugs : 65 - (DrugBank : 17) / Drug target genes : 50 - Drug target pathways : 64

  
2 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2019-001331-31-IT
(EUCTR)
18/12/201917/06/2021A 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 SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
2EUCTR2015-004167-37-IT
(EUCTR)
17/05/201615/11/2018Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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 LTDNULLNot RecruitingFemale: yes
Male: yes
260Phase 3France;Spain;Belgium;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Sweden;Korea, Republic of