13. 多発性硬化症/視神経脊髄炎
[臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228

Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
19 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03362294
(ClinicalTrials.gov)
December 11, 201715/11/2017Safety and Efficacy of Monthly Long-acting IM Injection of 40 mg GA Depot in Subjects With PPMSA Prospective, Multicenter, Single Arm, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)Primary Progressive Multiple SclerosisDrug: GA Depot 40mg once monthlyMapi Pharma Ltd.NULLRecruiting18 Years65 YearsAll24Phase 2Israel
2NCT02212886
(ClinicalTrials.gov)
October 20145/8/2014Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMSA Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: GA Depot 80 mg;Drug: GA Depot 40 mgMapi Pharma Ltd.NULLActive, not recruiting18 Years70 YearsAll25Phase 1;Phase 2Israel
3EUCTR2009-018084-27-BG
(EUCTR)
19/07/201030/04/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;South Africa;Georgia;Germany
4EUCTR2009-018084-27-DE
(EUCTR)
16/06/201009/03/2010A clincial study to find out whether Copaxone (glatiramer acetate 40mg/1ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
5EUCTR2009-018084-27-CZ
(EUCTR)
01/06/201029/03/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2009-018084-27-LT
(EUCTR)
28/05/201001/04/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
7EUCTR2009-018084-27-IT
(EUCTR)
19/05/201007/06/2010A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design - GALAA multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design - GALA Subject with Relapse-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Product Name: 40 mg Glatiramer Acetate
Product Code: 40 mg GA
INN or Proposed INN: Glatiramer acetate
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3Czech Republic;Estonia;Hungary;Lithuania;Bulgaria;Germany;United Kingdom;Italy
8EUCTR2009-018084-27-EE
(EUCTR)
07/05/201016/03/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Croatia;Romania;Georgia;South Africa;Bulgaria;Germany
9EUCTR2009-018084-27-HU
(EUCTR)
30/03/201001/03/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
10EUCTR2006-002037-20-EE
(EUCTR)
02/02/200704/12/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2006-002037-20-LT
(EUCTR)
30/11/200609/10/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Trade Name: Copaxone 20mg/ml Solution for Injection, pre-filled syringe
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
12EUCTR2006-002037-20-CZ
(EUCTR)
13/10/200628/08/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Trade Name: Copaxone 20 mg/ml, Solution for Injection, pre-filled syringes
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
13EUCTR2006-002037-20-BE
(EUCTR)
27/09/200619/07/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
14EUCTR2006-002037-20-DE
(EUCTR)
07/09/200620/10/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Czech Republic;United Kingdom;Germany;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
15EUCTR2006-002037-20-GB
(EUCTR)
07/09/200623/07/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2006-002037-20-LV
(EUCTR)
06/09/200623/08/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
17EUCTR2006-002037-20-HU
(EUCTR)
27/07/200623/05/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
18EUCTR2006-002037-20-IT
(EUCTR)
12/07/200630/08/2006A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTEA Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE Patients with Relapsing - Remitting Multiple Sclerosis.
MedDRA version: 6.1;Level: PT;Classification code 10028245
Product Name: 40 mg Glatiramer acetato
Product Code: 40 mg GA
INN or Proposed INN: Glatiramer acetate
Trade Name: COPAXONE*SC 28SIR 20MG/ML
INN or Proposed INN: Glatiramer acetate
Teva Pharmaceuticals Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
19EUCTR2006-002037-20-FI
(EUCTR)
12/07/200615/06/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Phase 3Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom