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-SE (EUCTR) | 17/06/2020 | 08/01/2020 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 2 | EUCTR2019-001331-31-DE (EUCTR) | 07/04/2020 | 13/11/2019 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 3 | EUCTR2019-001331-31-NL (EUCTR) | 12/03/2020 | 04/02/2020 | A 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 Syndrome | An 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 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;Netherlands;Germany;Japan;Sweden | ||
| 4 | EUCTR2019-001331-31-DK (EUCTR) | 17/01/2020 | 26/09/2019 | A 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 Syndrome | An 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 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;Denmark;Australia;Germany;Netherlands;Japan;Sweden | ||
| 5 | 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 | ||
| 6 | EUCTR2019-001331-31-FR (EUCTR) | 13/12/2019 | 16/10/2019 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;United States;Spain;United Kingdom;Germany;Japan;Sweden | ||
| 7 | EUCTR2019-001331-31-ES (EUCTR) | 10/12/2019 | 06/11/2019 | A 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 Syndrome | An 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 Limited | NULL | Authorised-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): no | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 8 | EUCTR2019-001331-31-BE (EUCTR) | 18/11/2019 | 26/09/2019 | A 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 Syndrome | An 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 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;Denmark;Australia;Netherlands;Germany;Japan;Sweden | ||
| 9 | JPRN-jRCT2041200095 | 18/11/2019 | 29/01/2021 | An 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 | An 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 syndrome | ZX008 (Fenfluramine Hydrochloride) Oral Solution Initial dose: 0.2mg/kg, Max daily dose: 30mg | YAMAMOTO Hideichiro | NULL | Not Recruiting | >= 2age old | <= 35age old | Both | 390 | Phase 3 | Australia;Belgium;Canda;Denmark;France;Germany;Italy;Korea;Netherland;Norway;Spain;Sweeded;UK;US;Japan |
| 10 | EUCTR2019-001331-31-GB (EUCTR) | 07/11/2019 | 29/08/2019 | A 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 Syndrome | An 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 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 | ||
| 11 | JPRN-JapicCTI-194872 | 31/7/2019 | 19/07/2019 | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive 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 | Dravet syndrome | Intervention name : ZX008 INN of the intervention : fenfluramine hydrochloride Dosage And administration of the intervention : Oral administration Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : - | Zogenix International Limited | NULL | complete | 2 | 18 | BOTH | 12 | Phase 3 | Japan, Europe, Australia |
| 12 | NCT03936777 (ClinicalTrials.gov) | April 22, 2019 | 12/4/2019 | A 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 Syndrome | An 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;Lennox Gastaut Syndrome;Epileptic Encephalopathy | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix, Inc. | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Active, not recruiting | 2 Years | N/A | All | 412 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Mexico;Netherlands;Poland;Spain;Sweden;United Kingdom |
| 13 | NCT03780127 (ClinicalTrials.gov) | October 12, 2018 | 14/12/2018 | ZX008 Expanded Access Protocol | ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan | Dravet Syndrome | Drug: Fenfluramine Hydrochloride | Zogenix, Inc. | NULL | Approved for marketing | 2 Years | N/A | All | NULL | ||
| 14 | NCT03467113 (ClinicalTrials.gov) | January 19, 2018 | 30/1/2018 | A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol | An Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: ZX008 0.2 to 0.8 mg/kg/day;Drug: Cannabidiol | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Completed | 2 Years | 18 Years | All | 9 | Phase 1 | United States |
| 15 | NCT03299842 (ClinicalTrials.gov) | August 23, 2017 | 10/9/2017 | A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome | An Exploratory, Pilot Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome: A Sub-study to the ZX008-1503 Open-Label Extension Trial | Dravet Syndrome | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Enrolling by invitation | N/A | N/A | All | 20 | Phase 3 | United States |
| 16 | EUCTR2016-000474-38-ES (EUCTR) | 31/05/2017 | 07/04/2017 | A Multicenter, Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 Oral Solution When Added to Standard of Care, Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to standar treatment in Children and Young Adults with Dravet Syndrome | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom | ||
| 17 | EUCTR2016-000474-38-GB (EUCTR) | 06/04/2017 | 17/01/2017 | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom | ||
| 18 | EUCTR2016-002804-14-IT (EUCTR) | 04/04/2017 | 07/09/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 310 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Sweden | ||
| 19 | EUCTR2016-002804-14-NL (EUCTR) | 04/04/2017 | 09/11/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 310 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 20 | EUCTR2016-000474-38-DE (EUCTR) | 31/03/2017 | 27/12/2016 | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom | ||
| 21 | NCT02926898 (ClinicalTrials.gov) | January 27, 2017 | 10/8/2016 | A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children = 2 Years Old and Young Adults With Dravet Syndrome | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome (Cohort 2) | Dravet Syndrome | Drug: ZX008 (Fenfluramine Hydrochloride);Drug: Matching Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Completed | 2 Years | 18 Years | All | 87 | Phase 3 | United States;Canada;France;Germany;Netherlands;Spain;United Kingdom |
| 22 | EUCTR2016-002804-14-ES (EUCTR) | 23/12/2016 | 26/10/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 310 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Sweden | ||
| 23 | EUCTR2016-002804-14-DK (EUCTR) | 15/11/2016 | 28/09/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;United States;Canada;Spain;Belgium;Australia;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 24 | EUCTR2016-002804-14-DE (EUCTR) | 11/11/2016 | 29/08/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 390 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 25 | EUCTR2015-004167-37-SE (EUCTR) | 09/11/2016 | 08/06/2016 | 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 Adolescents 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 26 | EUCTR2016-002804-14-GB (EUCTR) | 08/11/2016 | 11/08/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An 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 Limited | NULL | Authorised-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): no | France;United States;Canada;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 27 | EUCTR2016-002804-14-BE (EUCTR) | 26/09/2016 | 17/08/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An 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 | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 28 | EUCTR2016-000474-38-NL (EUCTR) | 13/09/2016 | 30/03/2016 | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | Dravet's syndrome MedDRA version: 18.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Spain;Germany;Netherlands;United Kingdom | ||
| 29 | NCT02826863 (ClinicalTrials.gov) | July 15, 2016 | 13/6/2016 | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive 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 | Dravet Syndrome | Drug: ZX008 - 0.8 mg/kg/day;Drug: ZX008 - 0.2 mg/kg/day;Drug: Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Recruiting | 2 Years | 18 Years | All | 130 | Phase 3 | Australia;Belgium;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom;Norway;Sweden |
| 30 | EUCTR2015-004167-37-DE (EUCTR) | 15/07/2016 | 10/02/2016 | 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 | 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | France;Spain;Belgium;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 31 | NCT02823145 (ClinicalTrials.gov) | July 5, 2016 | 13/6/2016 | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Completed | 2 Years | 35 Years | All | 373 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Netherlands;Spain;United Kingdom;Norway;Sweden |
| 32 | EUCTR2015-004167-37-DK (EUCTR) | 14/06/2016 | 18/03/2016 | 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 | 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 3 | France;Spain;Belgium;Australia;Denmark;Norway;Germany;United Kingdom;Switzerland;Japan;Italy;Sweden | ||
| 33 | EUCTR2015-004167-37-BE (EUCTR) | 30/05/2016 | 11/02/2016 | 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 | Dravet's syndrome MedDRA version: 18.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | 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 | ||
| 34 | 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 | ||
| 35 | EUCTR2015-004167-37-GB (EUCTR) | 17/05/2016 | 09/02/2016 | 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 | 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;Switzerland;United Kingdom;Sweden | ||
| 36 | EUCTR2015-004167-37-ES (EUCTR) | 12/05/2016 | 10/06/2016 | 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 | 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden | ||
| 37 | NCT02682927 (ClinicalTrials.gov) | January 15, 2016 | 5/2/2016 | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) 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 | Dravet Syndrome;Seizure Disorder | Drug: ZX008 (Fenfluramine Hydrochloride);Drug: Matching Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Completed | 2 Years | 18 Years | All | 262 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom |
| 38 | EUCTR2015-004167-37-NO (EUCTR) | 07/03/2016 | 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 | Dravet's syndrome MedDRA version: 18.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | NA | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Australia;Germany;Norway;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden | |||
| 39 | EUCTR2015-004167-37-FR (EUCTR) | 27/10/2016 | 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 | 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | NA | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden | |||
| 40 | EUCTR2019-001331-31-PL (EUCTR) | 20/04/2020 | A 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 Syndrome | An 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 Limited | NULL | NA | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden | |||
| 41 | EUCTR2016-002804-14-FR (EUCTR) | 12/01/2017 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An 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 Limited | NULL | NA | Female: yes Male: yes | 310 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Sweden |