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

  
11 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-002628-26-SE
(EUCTR)
21/01/201929/05/2018A 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 LGSA 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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
2EUCTR2017-002628-26-DE
(EUCTR)
15/11/201811/04/2018A 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 LGSA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden
3EUCTR2017-002628-26-FR
(EUCTR)
09/11/201814/08/2018 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.NULLAuthorised-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): noUnited States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
4EUCTR2017-002628-26-NL
(EUCTR)
24/09/201806/06/2018A 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 LGSA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
5EUCTR2017-002628-26-BE
(EUCTR)
23/07/201830/03/2018A 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 LGSA 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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
6EUCTR2017-002628-26-IT
(EUCTR)
16/07/201825/05/2018 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.NULLAuthorised-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): noUnited States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
7EUCTR2017-002628-26-DK
(EUCTR)
09/07/201817/05/2018A 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 LGSA 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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden
8EUCTR2017-002628-26-ES
(EUCTR)
12/06/201820/04/2018A 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 LGSA 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
9EUCTR2017-002628-26-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.NULLNA Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
10EUCTR2017-002628-26-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.NULLNot 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): noUnited States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
11EUCTR2017-002628-26-PL
(EUCTR)
21/08/2018A 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 LGSA 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.NULLNot RecruitingFemale: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden