144. Lennox-Gastaut syndrome Clinical trials / Disease details
Clinical trials : 111 / Drugs : 72 - (DrugBank : 14) / Drug target genes : 49 - Drug target pathways : 61
| 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 | EUCTR2017-002628-26-SE (EUCTR) | 21/01/2019 | 29/05/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 2 | EUCTR2017-002628-26-DE (EUCTR) | 15/11/2018 | 11/04/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 3 | EUCTR2017-002628-26-FR (EUCTR) | 09/11/2018 | 14/08/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 4 | EUCTR2017-002628-26-NL (EUCTR) | 24/09/2018 | 06/06/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 5 | EUCTR2017-002628-26-BE (EUCTR) | 23/07/2018 | 30/03/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 6 | EUCTR2017-002628-26-IT (EUCTR) | 16/07/2018 | 25/05/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 7 | EUCTR2017-002628-26-DK (EUCTR) | 09/07/2018 | 17/05/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden | ||
| 8 | EUCTR2017-002628-26-ES (EUCTR) | 12/06/2018 | 20/04/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 9 | EUCTR2017-002628-26-PL (EUCTR) | 21/08/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| 10 | EUCTR2017-002628-26-AT (EUCTR) | 16/05/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| 11 | EUCTR2017-002628-26-GB (EUCTR) | 22/05/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | NA | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden |