Glatiramer acetate (ga) (DrugBank: Glatiramer, Acetate)
43 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 1 | 球脊髄性筋萎縮症 | 0 |
| 2 | 筋萎縮性側索硬化症 | 0 |
| 6 | パーキンソン病 | 0 |
| 10 | シャルコー・マリー・トゥース病 | 0 |
| 13 | 多発性硬化症／視神経脊髄炎 | 31 |
| 35 | 天疱瘡 | 0 |
| 40 | 高安動脈炎 | 0 |
| 46 | 悪性関節リウマチ | 0 |
| 49 | 全身性エリテマトーデス | 0 |
| 51 | 全身性強皮症 | 0 |
| 60 | 再生不良性貧血 | 0 |
| 64 | 血栓性血小板減少性紫斑病 | 0 |
| 67 | 多発性嚢胞腎 | 0 |
| 70 | 広範脊柱管狭窄症 | 0 |
| 71 | 特発性大腿骨頭壊死症 | 0 |
| 73 | 下垂体性TSH分泌亢進症 | 0 |
| 75 | クッシング病 | 0 |
| 76 | 下垂体性ゴナドトロピン分泌亢進症 | 0 |
| 78 | 下垂体前葉機能低下症 | 0 |
| 79 | 家族性高コレステロール血症（ホモ接合体） | 0 |
| 81 | 先天性副腎皮質酵素欠損症 | 0 |
| 83 | アジソン病 | 0 |
| 85 | 特発性間質性肺炎 | 0 |
| 86 | 肺動脈性肺高血圧症 | 0 |
| 88 | 慢性血栓塞栓性肺高血圧症 | 0 |
| 90 | 網膜色素変性症 | 0 |
| 96 | クローン病 | 0 |
| 97 | 潰瘍性大腸炎 | 0 |
| 113 | 筋ジストロフィー | 0 |
| 145 | ウエスト症候群 | 0 |
| 156 | レット症候群 | 0 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 0 |
| 171 | ウィルソン病 | 0 |
| 206 | 脆弱X症候群 | 0 |
| 222 | 一次性ネフローゼ症候群 | 0 |
| 224 | 紫斑病性腎炎 | 0 |
| 225 | 先天性腎性尿崩症 | 0 |
| 227 | オスラー病 | 0 |
| 235 | 副甲状腺機能低下症 | 0 |
| 265 | 脂肪萎縮症 | 0 |
| 288 | 自己免疫性後天性凝固因子欠乏症［自己免疫性出血病XIII (~2017.3)］ | 0 |
| 298 | 遺伝性膵炎 | 0 |
| 299 | 嚢胞性線維症 | 0 |
| 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 | EUCTR2011-005550-57-GR (EUCTR) | 05/06/2012 | 09/05/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) 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] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Serbia;Ukraine;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of | |||
| 2 | EUCTR2011-005550-57-EE (EUCTR) | 21/05/2012 | 14/02/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) 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] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | |||
| 3 | EUCTR2011-005550-57-LV (EUCTR) | 15/05/2012 | 09/02/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) 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] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | |||
| 4 | EUCTR2011-005550-57-BG (EUCTR) | 14/05/2012 | 07/03/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) 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] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Germany;Moldova, Republic of;Bosnia and Herzegovina;Latvia;Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Bulgaria;Albania | |||
| 5 | EUCTR2011-005550-57-PL (EUCTR) | 04/04/2012 | 09/03/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) 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] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Hungary;Germany;Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Czech Republic;Ukraine;Serbia;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of | |||
| 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 |
| 6 | NCT01578785 (ClinicalTrials.gov) | March 2012 | 13/3/2012 | An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Placebo | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 55 Years | All | 178 | Phase 3 | United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Greece;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Montenegro;Poland;Romania;Russian Federation;Serbia;Ukraine;Lithuania |
| 7 | NCT01534182 (ClinicalTrials.gov) | January 2012 | 8/2/2012 | Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Interferon beta - 1a (IFN);Drug: Glatiramer acetate (GA) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 298 | Phase 4 | Russian Federation |
| 8 | EUCTR2009-018084-27-GB (EUCTR) | 29/07/2010 | 08/06/2010 | A 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: 16.1;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] | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Poland;Croatia;Romania;South Africa;Georgia;Bulgaria;Germany;United States;Estonia;Ukraine;Lithuania;Israel | |||
| 9 | EUCTR2009-018084-27-BG (EUCTR) | 19/07/2010 | 30/04/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;South Africa;Georgia;Germany | ||
| 10 | NCT01167426 (ClinicalTrials.gov) | July 2010 | 20/7/2010 | Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients | An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method. | Multiple Sclerosis | Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | N/A | All | 148 | Phase 3 | United States |
| 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 |
| 11 | NCT01067521 (ClinicalTrials.gov) | June 22, 2010 | 10/2/2010 | A Study 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 | 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 | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer acetate (GA);Drug: Placebo | Teva Pharmaceutical Industries, Ltd. | NULL | Completed | 18 Years | 55 Years | All | 1404 | Phase 3 | United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Poland;Romania;Russian Federation;South Africa;Ukraine;United Kingdom;Czech Republic;Turkey |
| 12 | EUCTR2009-018084-27-DE (EUCTR) | 16/06/2010 | 09/03/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 13 | EUCTR2009-018084-27-CZ (EUCTR) | 01/06/2010 | 29/03/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 14 | NCT01156311 (ClinicalTrials.gov) | June 2010 | 1/7/2010 | BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis | An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNß) or Glatiramer Acetate (GA) | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 108 | Phase 2 | United States |
| 15 | EUCTR2009-018084-27-LT (EUCTR) | 28/05/2010 | 01/04/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 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 |
| 16 | EUCTR2009-018084-27-IT (EUCTR) | 19/05/2010 | 07/06/2010 | 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 | 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 | 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. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Czech Republic;Estonia;Hungary;Lithuania;Bulgaria;Germany;United Kingdom;Italy | ||
| 17 | EUCTR2009-018084-27-EE (EUCTR) | 07/05/2010 | 16/03/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Croatia;Romania;Georgia;South Africa;Bulgaria;Germany | ||
| 18 | EUCTR2009-018084-27-HU (EUCTR) | 30/03/2010 | 01/03/2010 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 19 | NCT00947752 (ClinicalTrials.gov) | July 2009 | 25/7/2009 | Safety of New Formulation of Glatiramer Acetate | An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Experimental Glatiramer Acetate | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | N/A | All | 147 | Phase 3 | United States |
| 20 | NCT00937157 (ClinicalTrials.gov) | September 2007 | 9/7/2009 | Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA) | Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study | Multiple Sclerosis | Drug: Copaxone | University at Buffalo | Teva Neuroscience, Inc. | Completed | 18 Years | 65 Years | All | 12 | N/A | United States |
| 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 |
| 21 | EUCTR2004-000463-94-HU (EUCTR) | 03/07/2007 | 12/07/2004 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | Relapsing-remitting multiple sclerosis (R-R MS) MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Glatiramer acetate 150mg enteric coated tablets INN or Proposed INN: Glatiramer Acetate Other descriptive name: COP-1/Copolymer-1 | TEVA Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Hungary;Italy | |||
| 22 | NCT00475865 (ClinicalTrials.gov) | April 2007 | 18/5/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 123 | Phase 2 | United States;Austria;Canada;Germany;Italy;United Kingdom |
| 23 | NCT00337779 (ClinicalTrials.gov) | August 2006 | 14/6/2006 | Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA). | A 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) | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate (GA) 40 mg;Drug: glatiramer acetate 20 mg | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | All | 1155 | Phase 3 | Argentina;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain;United Kingdom;United States |
| 24 | NCT00203047 (ClinicalTrials.gov) | January 2005 | 13/9/2005 | Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate | A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA) | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Placebo;Drug: Prednisone | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 55 Years | All | 414 | Phase 4 | Canada;United States |
| 25 | NCT00203099 (ClinicalTrials.gov) | December 2004 | 13/9/2005 | Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine | A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS) | Relapse Remitting Multiple Sclerosis | Drug: Glatiramer Acetate, N-Acetylcysteine | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 18 | Phase 2 | Canada |
| 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 |
| 26 | EUCTR2004-000463-94-IT (EUCTR) | 11/10/2004 | 16/02/2005 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | Subject with relapsing remitting multiple sclerosis. Subject must have at least one documented relapse within one year prior to screening visit MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: glatiramer acetate Product Code: GA INN or Proposed INN: Glatiramer acetate | TEVA | NULL | Not Recruiting | Female: yes Male: yes | 25 | Hungary;Italy | |||
| 27 | EUCTR2004-000462-13-IT (EUCTR) | 30/07/2004 | 17/09/2004 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | Subjects with Relapsing-Remitting Multiple Sclerosis.Subjects must have had at least one documented relapse within one year prior to screening visit MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: glatiramer acetate Product Code: GA INN or Proposed INN: Glatiramer acetate | TEVA | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Italy | ||||
| 28 | EUCTR2004-000462-13-HU (EUCTR) | 12/07/2004 | 12/07/2004 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | Relapsing-remitting multiple sclerosis (R-R MS) MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Glatiramer acetate 150mg enteric-coated (gastro-resistant) tablets INN or Proposed INN: Glatiramer Acetate Other descriptive name: COP-1/Copolymer-1 | TEVA Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Hungary;Italy | |||
| 29 | NCT00203112 (ClinicalTrials.gov) | June 2004 | 13/9/2005 | Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline | A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA). | Relapse Remitting Multiple Sclerosis | Drug: glatiramer acetate with minocycline;Drug: Glatiramer acetate with placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 44 | Phase 2 | Canada |
| 30 | NCT00203073 (ClinicalTrials.gov) | June 2003 | 13/9/2005 | A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis. | A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantrone | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | Both | 40 | Phase 2 | United States;Canada |
| 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 |
| 31 | NCT00097760 (ClinicalTrials.gov) | June 2003 | 30/11/2004 | Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis | Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA) | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab;Drug: Placebo | Biogen Idec | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 110 | Phase 2 | NULL |