2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225

  
19 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2020-004590-51-IT
(EUCTR)
24/01/202207/06/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: nd
Product Code: [BIIB067 (ISIS666853)]
INN or Proposed INN: tofersen
Other descriptive name: BIIB067
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
2EUCTR2020-004590-51-DE
(EUCTR)
15/09/202119/03/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Germany;Japan;Sweden;Korea, Republic of
3EUCTR2016-003225-41-ES
(EUCTR)
28/06/202114/06/2021Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3United States;Spain;Israel;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;New Zealand
4EUCTR2020-004590-51-FR
(EUCTR)
03/06/202101/04/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
5EUCTR2020-004590-51-ES
(EUCTR)
17/05/202101/09/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
6NCT04856982
(ClinicalTrials.gov)
May 17, 202120/4/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationAmyotrophic Lateral Sclerosis Associated With a SOD1 Gene MutationDrug: BIIB067 (Tofersen);Drug: PlaceboBiogenNULLRecruiting18 YearsN/AAll150Phase 3United States;Australia;Belgium;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain;Sweden;United Kingdom;Russian Federation
7EUCTR2016-003225-41-DK
(EUCTR)
16/12/202009/06/2020Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Denmark;Australia;Germany;Japan;New Zealand
8EUCTR2016-003225-41-PL
(EUCTR)
01/12/202022/07/2020Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: -
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
183Phase 3United States;European Union;Canada;Argentina;Belgium;Poland;Denmark;Australia;Germany;United Kingdom;Japan;Korea, Republic of
9EUCTR2015-004098-33-PL
(EUCTR)
18/11/202010/07/2020An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - VALOR (Part C) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
183Phase 3United States;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Australia;Denmark;Germany;Japan;Korea, Republic of;Sweden
10EUCTR2015-004098-33-DK
(EUCTR)
23/03/202002/03/2020An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - VALOR (Part C) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
183Phase 1;Phase 2;Phase 3France;United States;Canada;Poland;Belgium;Australia;Denmark;Germany;United Kingdom;Italy;Japan;Sweden
11EUCTR2016-003225-41-IT
(EUCTR)
10/02/202015/06/2021Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - na Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: nd
Product Code: [BIIB067 (ISIS666853)]
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
182Phase 3United States;European Union;Canada;Spain;Poland;Belgium;Denmark;Australia;Germany;United Kingdom;Japan;Italy
12EUCTR2016-003225-41-DE
(EUCTR)
06/09/201815/09/2017Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;New Zealand
13EUCTR2016-003225-41-GB
(EUCTR)
20/09/201702/06/2017Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - Biogen 233AS102 Study of BIIB067 in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: -
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 1;Phase 3United States;Japan;United Kingdom;Spain;Canada;Sweden;Belgium;Denmark;Poland;Italy;Australia;France;Germany
14EUCTR2016-003225-41-BE
(EUCTR)
10/04/201710/04/2017Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;Korea, Republic of
15NCT03070119
(ClinicalTrials.gov)
March 8, 201728/2/2017Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 MutationALS Caused by Superoxide Dismutase 1 (SOD1) MutationDrug: BIIB067BiogenIonis Pharmaceuticals, Inc.Active, not recruiting18 YearsN/AAll138Phase 3United States;Belgium;Canada;France;Germany;Italy;Japan;New Zealand;United Kingdom
16EUCTR2015-004098-33-DE
(EUCTR)
16/08/201607/12/2015An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
183Phase 1;Phase 2;Phase 3United States;Japan;United Kingdom;Canada;Sweden;Belgium;Denmark;Korea, Republic of;Poland;Italy;Australia;France;Germany
17EUCTR2015-004098-33-SE
(EUCTR)
29/06/201627/11/2015An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
144Phase 1;Phase 2;Phase 3Belgium;United States;France;Canada;Denmark;Australia;Germany;United Kingdom;Japan;Italy;Sweden
18EUCTR2015-004098-33-GB
(EUCTR)
18/04/201610/12/2015An Efficacy, Safety, Tolerability, Pharmacokinetics and PharmacodynamicsStudy of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics andPharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - Biogen 233AS101 Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 1;Phase 2;Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;Japan;Italy;United Kingdom;Korea, Republic of;Sweden
19EUCTR2015-004098-33-BE
(EUCTR)
01/03/201614/01/2016An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
144Phase 1;Phase 2;Phase 3United States;France;Canada;Poland;Belgium;Denmark;Australia;Germany;United Kingdom;Japan;Italy;Sweden