144. レノックス・ガストー症候群 Lennox-Gastaut syndrome Clinical trials / Disease details


臨床試験数 : 111 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61

  
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2019-001331-31-SE
(EUCTR)
17/06/202008/01/2020A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
2EUCTR2019-001331-31-DE
(EUCTR)
07/04/202013/11/2019A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
3EUCTR2019-001331-31-NL
(EUCTR)
12/03/202004/02/2020A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
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;Netherlands;Germany;Japan;Sweden
4EUCTR2019-001331-31-DK
(EUCTR)
17/01/202026/09/2019A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
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;Denmark;Australia;Germany;Netherlands;Japan;Sweden
5EUCTR2019-001331-31-FR
(EUCTR)
13/12/201916/10/2019A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;United States;Spain;United Kingdom;Germany;Japan;Sweden
6EUCTR2019-001331-31-ES
(EUCTR)
10/12/201906/11/2019A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
650 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden
7EUCTR2019-001331-31-BE
(EUCTR)
18/11/201926/09/2019A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
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;Denmark;Australia;Netherlands;Germany;Japan;Sweden
8EUCTR2019-001331-31-GB
(EUCTR)
07/11/201929/08/2019A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
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
9EUCTR2019-001331-31-PL
(EUCTR)
20/04/2020A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy 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 for Seizures 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: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLNAFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden