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

  
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002804-14-IT
(EUCTR)
04/04/201707/09/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome Dravet's syndrome
MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (red)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red)
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless)
Zogenix International LimitedNULLNot RecruitingFemale: yes
Male: yes
310Phase 3United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Sweden
2EUCTR2016-002804-14-NL
(EUCTR)
04/04/201709/11/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome Dravet's syndrome
MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (red)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red)
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless)
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
310Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;Sweden
3EUCTR2016-002804-14-ES
(EUCTR)
23/12/201626/10/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome Dravet's syndrome
MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (red)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red)
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless)
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
310Phase 3France;United States;Canada;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Sweden
4EUCTR2016-002804-14-DK
(EUCTR)
15/11/201628/09/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome Seizures associated with 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: Fenfluramine hydrochloride (red)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red)
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless)
Zogenix International LimitedNULLNot RecruitingFemale: yes
Male: yes
390Phase 3France;United States;Canada;Spain;Belgium;Australia;Denmark;Netherlands;Germany;United Kingdom;Italy
5EUCTR2016-002804-14-DE
(EUCTR)
11/11/201629/08/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome Seizures associated with Dravet's 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: Fenfluramine hydrochloride (red)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red)
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless)
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Phase 3United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
6EUCTR2016-002804-14-GB
(EUCTR)
08/11/201611/08/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome Seizures associated with 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: Fenfluramine hydrochloride (red)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red)
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless)
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
390 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
7EUCTR2016-002804-14-BE
(EUCTR)
26/09/201617/08/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome Seizures associated with Dravet's 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: Fenfluramine hydrochloride (red)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red)
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless)
Zogenix International LimitedNULLNot RecruitingFemale: yes
Male: yes
390Phase 3United States;France;Canada;Spain;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
8EUCTR2016-002804-14-FR
(EUCTR)
12/01/2017Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome Dravet's syndrome
MedDRA version: 19.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (red)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red)
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless)
Zogenix International LimitedNULLNAFemale: yes
Male: yes
310Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Sweden