GLA ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 243 |
| 19 | ライソゾーム病 | 39 |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | NCT05131971 (ClinicalTrials.gov) | November 1, 2021 | 27/10/2021 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants | A Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3888130B in Healthy Participants Aged 18-55 Inclusive | Multiple Sclerosis | Drug: Placebo;Drug: GSK3888130B | GlaxoSmithKline | NULL | Recruiting | 18 Years | 55 Years | All | 70 | Phase 1 | United Kingdom |
| 2 | NCT04767698 (ClinicalTrials.gov) | October 1, 2021 | 18/2/2021 | Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis | Addition of Belimumab to B-cell Depletion to Produce Prolonged Remission of Relapsing-remitting Multiple Sclerosis Disease Activity | Multiple Sclerosis | Drug: Belimumab;Drug: Short-course Ocrelizumab;Drug: Continued Ocrelizumab | Johns Hopkins University | GlaxoSmithKline | Terminated | 18 Years | N/A | All | 3 | Phase 2 | United States |
| 3 | NCT05688436 (ClinicalTrials.gov) | September 24, 2021 | 9/1/2023 | A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate | Pregnancy Outcomes in Women Exposed to Diroximel Fumarate | Multiple Sclerosis | Drug: Diroximel Fumarate;Biological: Alemtuzumab;Drug: Fingolimod;Drug: Glatiramer acetate;Biological: Interferon beta;Biological: Natalizumab;Biological: Ocrelizumab;Biological: Peginterferon beta-1a;Drug: Siponimod | Biogen | NULL | Recruiting | 18 Years | 49 Years | Female | 825 | United States | |
| 4 | EUCTR2020-004505-32-IT (EUCTR) | 24/09/2021 | 12/10/2021 | Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mgSC monthly vs. First Line DMT - physician’s choice in the treatment of newly diagnosed RMS (STHENOS) - STHENOS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE 28 SIRINGHE PRERIEMPITE Product Name: COPAXONE Product Code: [-] INN or Proposed INN: glatiramer acetato Trade Name: Rebif Product Name: Rebif Product Code: [-] INN or Proposed INN: interferone beta-1a Trade Name: Rebif Product Name: rebif Product Code: [-] INN or Proposed INN: interferone beta-1a Trade Name: plegridy Product Name: plegridy Product Code: [-] INN or Proposed INN: peginterferone beta 1a Trade Name: Avonex Product Name: Avonex Product Code: [-] INN or Proposed INN: Interferone beta 1a Trade Name: Extavia Product Name: Extavia Product Code: [-] INN or Proposed INN: interferone beta-1b Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Germany;Italy | ||
| 5 | EUCTR2020-004505-32-DE (EUCTR) | 06/07/2021 | 25/05/2021 | Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Product Name: Glatiramer acetate INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Product Name: Glatiramer acetate INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Product Name: Interferon ß-1b INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Germany;United Kingdom;Italy | ||
| 6 | NCT04079088 (ClinicalTrials.gov) | June 30, 2021 | 3/9/2019 | Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) | A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Placebo;Drug: BIIB061;Biological: Interferon-beta1;Drug: Glatiramer acetate | Biogen | NULL | Not yet recruiting | 18 Years | 55 Years | All | 300 | Phase 2 | NULL |
| 7 | EUCTR2020-004505-32-FR (EUCTR) | 09/06/2021 | 26/04/2021 | Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Product Name: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Product Name: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Product Name: Interferon ß-1b Other descriptive name: INTERFERON BETA-1B Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Germany | ||
| 8 | EUCTR2020-005752-38-DE (EUCTR) | 18/03/2021 | 19/01/2021 | An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC) | An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC) | secondary progressive multiple sclerosis (SPMS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mayzent 2 mg Filmtabletten Product Name: Mayzent 2 mg Filmtabletten Product Code: BAF312A INN or Proposed INN: SIPONIMOD Other descriptive name: Siponimod Trade Name: Mayzent 0,25 mg Filmtabletten Product Name: Mayzent 0,25 mg Filmtabletten Product Code: BAF312A INN or Proposed INN: SIPONIMOD Other descriptive name: Siponimod Trade Name: Spikevax INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE INN or Proposed INN: TERIFLUNOMIDE INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE INN or Proposed INN: RECOMBINANT INTERFERON BE | Novartis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Germany | ||
| 9 | EUCTR2018-000284-93-EE (EUCTR) | 10/12/2019 | 02/10/2019 | A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks | A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GA Depot INN or Proposed INN: GLATIRAMER ACETATE | Mapi Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | United States;Serbia;Belarus;Estonia;Ukraine;Russian Federation;Israel;Montenegro;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Croatia;Romania;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 10 | EUCTR2018-000284-93-BG (EUCTR) | 15/11/2019 | 08/10/2019 | A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks | A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GA Depot INN or Proposed INN: GLATIRAMER ACETATE | Mapi Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Belarus;Estonia;Ukraine;Russian Federation;Israel;Georgia;Bulgaria;Montenegro;Moldova, Republic of;Bosnia and Herzegovina | ||
| 11 | NCT04121221 (ClinicalTrials.gov) | September 19, 2019 | 8/10/2019 | A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS | A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to Placebo | Multiple Sclerosis, Relapsing-Remitting | Drug: GA Depot;Other: Placebo | Mapi Pharma Ltd. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 1016 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Estonia;Georgia;Israel;Moldova, Republic of;Russian Federation;Ukraine |
| 12 | EUCTR2017-005129-18-IT (EUCTR) | 08/01/2019 | 26/03/2018 | Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis. | Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis. | Relapsing-remitting multiple sclerosis with paediatric onset MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 40 mg/ml solution for injection, pre-filled syringe INN or Proposed INN: Glatiramer Acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: AVONEX 30 µg/0,5 ml solution for injection INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Università degli Studi Aldo Moro | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Italy | ||
| 13 | NCT05762003 (ClinicalTrials.gov) | January 1, 2019 | 9/2/2023 | Czech Pharmaco-epidemiological Study on Disease Modifying Drugs | Czech Pharmaco-epidemiological Real World Data Study Focused on Effectiveness of Different Disease Modifying Drugs | Multiple Sclerosis | Drug: interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab | IMPULS Endowment Fund | NULL | Completed | N/A | N/A | All | 17478 | Czechia | |
| 14 | NCT03944447 (ClinicalTrials.gov) | December 1, 2018 | 3/5/2019 | Outcomes Mandate National Integration With Cannabis as Medicine | Outcomes Mandate National Integration With Cannabis as Medicine | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus | Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler | OMNI Medical Services, LLC | OMNI Medical Services Inc | Recruiting | 7 Years | N/A | All | 200000 | Phase 2 | United States |
| 15 | EUCTR2016-004819-12-IT (EUCTR) | 10/01/2018 | 20/01/2022 | Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients | Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders | Relapsing-Remitting multiple sclerosis (RR-MS), MedDRA version: 21.1;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] | Trade Name: BETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 ML Product Name: Interferone Beta-1B Product Code: [032166011] INN or Proposed INN: INTERFERONE BETA 1B Other descriptive name: Interferon Beta-1B Trade Name: AVONEX - 30 MCG (6 MILIONI UI) POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 4 FLACONI CON DISPOSITIVO BIOSET + 4 SIRINGHE PRERIEMPITE USO INTRAMUSCOLARE Product Name: Inteferone Beta-1A Product Code: [033283045] INN or Proposed INN: INTERFERON BETA - 1A Other descriptive name: Interferon Beta 1-A Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO Product Name: Glatiramer acetato Product Code: [035418060] INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: Glatiramer acetate Trade Name: REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML)12 PENNE PRERIEMPITE Product Name: Interferon Beta-1a Product Code: [034091165] INN or Proposed INN: INTERFERON BETA - 1A Other descriptive name: Interferon Beta-1a | OSPEDALE SAN RAFFAELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 4 | Italy | ||
| 16 | NCT03362294 (ClinicalTrials.gov) | December 11, 2017 | 15/11/2017 | Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS | A Prospective, Multicenter, Two Arms, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 25 mg or 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS) | Primary Progressive Multiple Sclerosis | Drug: GA Depot 40mg once monthly;Drug: GA Depot 25mg once monthly | Mapi Pharma Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 30 | Phase 2 | Israel;Moldova, Republic of |
| 17 | NCT03315923 (ClinicalTrials.gov) | December 1, 2017 | 17/10/2017 | Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients | Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate | Secondary Progressive Multiple Sclerosis | Drug: Rituximab;Drug: Glatiramer Acetate | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 55 Years | All | 84 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 18 | NCT03368664 (ClinicalTrials.gov) | October 24, 2017 | 2/11/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis | Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 10 Years | 17 Years | All | 50 | Phase 3 | Austria;Belgium;France;Italy;Netherlands;Poland;Portugal;Russian Federation;Turkey;United Kingdom;Bulgaria;Czechia;Germany;Greece;Norway;Spain;Switzerland |
| 19 | EUCTR2017-002634-24-SE (EUCTR) | 29/09/2017 | 06/07/2017 | MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis. | MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS | Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Sweden | ||
| 20 | EUCTR2016-003587-39-SE (EUCTR) | 22/05/2017 | 23/03/2017 | This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval. | COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) | Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3700 | Phase 4 | Sweden | ||
| 21 | EUCTR2015-003147-19-GR (EUCTR) | 18/07/2016 | 25/05/2016 | To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS). | Novel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Controlled, Add-on with Interferon Beta, Trial of Efficacy and Safety. - Efficacy and Safety study of NEUROASPIS PLP10® versus placebo | Relapsing-Remitting Multiple Sclerosis (RRMS) 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: NEUROASPIS PLP10® INN or Proposed INN: FISH OIL,RICH IN OMEGA 3 ACIDS Other descriptive name: FISH OIL, RICH IN OMEGA-3-ACIDS INN or Proposed INN: BORAGE OIL 20% GLA Other descriptive name: BORAGE OIL INN or Proposed INN: beta-Carotene Other descriptive name: BETACAROTENE INN or Proposed INN: Gamma-tocopherol | PALUPA Medical Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Greece | ||
| 22 | EUCTR2015-000922-12-DE (EUCTR) | 12/02/2016 | 02/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 23 | EUCTR2015-000922-12-FR (EUCTR) | 28/01/2016 | 26/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 24 | EUCTR2015-000922-12-ES (EUCTR) | 12/01/2016 | 13/01/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 820 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 25 | EUCTR2015-000922-12-PL (EUCTR) | 05/01/2016 | 03/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 26 | EUCTR2015-000922-12-BE (EUCTR) | 04/01/2016 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 27 | EUCTR2015-000922-12-IE (EUCTR) | 22/12/2015 | 09/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 28 | EUCTR2015-004116-38-SE (EUCTR) | 18/12/2015 | 20/10/2015 | A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis. | RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed. | Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Department of Clinical Sciences, Danderyd Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Sweden | ||
| 29 | EUCTR2015-000922-12-FI (EUCTR) | 15/12/2015 | 07/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 30 | EUCTR2015-000922-12-HR (EUCTR) | 11/12/2015 | 04/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 31 | NCT03209479 (ClinicalTrials.gov) | November 24, 2015 | 4/7/2017 | Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple Sclerosis | Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple Sclerosis | Multiple Sclerosis | Drug: Glatiramer acetate | Takeda | NULL | Recruiting | N/A | N/A | All | 1000 | Japan | |
| 32 | JPRN-JapicCTI-153058 | 24/11/2015 | 04/11/2015 | Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple Sclerosis | Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple Sclerosis | Multiple sclerosis | Intervention name : Copaxone subcutaneous injection syringe Dosage And administration of the intervention : For adults, a 20 mg dose of glatiramer acetate will be subcutaneously administered once daily.Participants will receive interventions as part of routine medical care. | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | recruiting | BOTH | 1000 | NA | NULL | ||
| 33 | EUCTR2015-000922-12-AT (EUCTR) | 19/11/2015 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 34 | EUCTR2012-003735-32-GR (EUCTR) | 19/11/2015 | 06/08/2015 | Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Relapsing-remitting multiple sclerosis (RR MS) MedDRA version: 18.0;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: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| 35 | EUCTR2015-000922-12-IT (EUCTR) | 05/11/2015 | 28/02/2018 | A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;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] | Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO | TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 36 | NCT02499900 (ClinicalTrials.gov) | August 10, 2015 | 1/7/2015 | CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily | CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily | Multiple Sclerosis | Drug: Copaxone® | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | N/A | All | 861 | Phase 4 | United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey |
| 37 | NCT02323269 (ClinicalTrials.gov) | May 2015 | 18/12/2014 | Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve) | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve) | Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Terminated | 18 Years | N/A | Both | 24 | N/A | Canada |
| 38 | NCT04928313 (ClinicalTrials.gov) | April 12, 2015 | 14/4/2021 | Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran | A Phase IV, Post-marketing, Prospective, Multicenter Study to Investigate the Safety and Effectiveness of Cinnomer® (Glatiramer-Acetate) in Multiple Sclerosis (MS) Treatment in Iran | Relapsing Multiple Sclerosis | Drug: Glatiramer Acetate | Cinnagen | NULL | Completed | 18 Years | 60 Years | All | 368 | Phase 4 | NULL |
| 39 | EUCTR2012-003735-32-SK (EUCTR) | 01/04/2015 | 09/04/2015 | Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| 40 | EUCTR2012-005086-12-PL (EUCTR) | 07/01/2015 | 16/09/2014 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis 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] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany | ||
| 41 | EUCTR2014-001012-19-NL (EUCTR) | 17/12/2014 | 15/10/2014 | Effects of fingolimod on advanced brain measures and clinical measures in multiple sclerosis | Effects of fingolimod on functional brain adaptation and clinical measures in multiple sclerosis - Effect of fingolimod on brain and cognition | Relapsing-remitting (RR) multiple sclerosis (MS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: fingolimod Product Name: Interferon Beta INN or Proposed INN: interferon beta-1b Other descriptive name: INTERFERON BETA-1B INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Trade Name: Copaxone INN or Proposed INN: glatiramer acetate | VU University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 42 | EUCTR2013-002378-26-SE (EUCTR) | 13/11/2014 | 15/08/2013 | Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes | Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext | The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial. MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera® Product Name: Mabthera | Västerbottens Läns Landsting | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 2 | Sweden | ||
| 43 | NCT02212886 (ClinicalTrials.gov) | October 2014 | 5/8/2014 | Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS | A 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 Sclerosis | Drug: GA Depot 80 mg;Drug: GA Depot 40 mg | Mapi Pharma Ltd. | NULL | Active, not recruiting | 18 Years | 70 Years | All | 25 | Phase 1/Phase 2 | Israel |
| 44 | EUCTR2013-002283-25-PL (EUCTR) | 18/04/2014 | 21/01/2014 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) 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: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 45 | EUCTR2013-002283-25-GR (EUCTR) | 18/03/2014 | 01/11/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) 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] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 46 | EUCTR2013-002283-25-GB (EUCTR) | 18/03/2014 | 09/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) 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: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 47 | EUCTR2013-002283-25-BG (EUCTR) | 07/02/2014 | 04/12/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) 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: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 48 | EUCTR2013-002283-25-ES (EUCTR) | 31/01/2014 | 06/11/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) 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] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 49 | EUCTR2013-004626-28-FI (EUCTR) | 20/12/2013 | 20/11/2013 | Does targeting of S1P receptors reduce microglial activation in multiple sclerosis? | Does targeting of S1P receptors reduce microglial activation in multiple sclerosis? | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: REBIF Product Name: beetainterferoni -1a Other descriptive name: INTERFERON BETA-1A Trade Name: Gilenya Product Name: Fingolimodi Other descriptive name: FINGOLIMOD Trade Name: Avonex Trade Name: Betaferon Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Lemtrada Other descriptive name: ALEMTUZUMAB | Turku University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Finland | ||
| 50 | EUCTR2013-002283-25-CZ (EUCTR) | 18/12/2013 | 26/09/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) 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: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 51 | EUCTR2013-002283-25-FI (EUCTR) | 09/12/2013 | 25/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) 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: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 52 | EUCTR2013-002283-25-HU (EUCTR) | 25/11/2013 | 08/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) 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: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 53 | EUCTR2012-005086-12-BG (EUCTR) | 14/11/2013 | 19/08/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.1;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] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 54 | EUCTR2012-005086-12-DE (EUCTR) | 12/11/2013 | 01/07/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis 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] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 55 | EUCTR2013-002283-25-IT (EUCTR) | 29/10/2013 | 08/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.0;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: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 56 | NCT01903291 (ClinicalTrials.gov) | August 2013 | 17/7/2013 | Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate | Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 333 | N/A | United States |
| 57 | EUCTR2012-005086-12-HU (EUCTR) | 31/07/2013 | 18/06/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis 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] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 58 | EUCTR2012-005086-12-AT (EUCTR) | 05/07/2013 | 08/05/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.0;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] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 59 | NCT01874145 (ClinicalTrials.gov) | June 2013 | 6/6/2013 | Safety and Tolerability of Glatiramer Acetate | An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: GA 20 mg/mL;Drug: GA 40 mg/mL | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | N/A | All | 209 | Phase 3 | United States |
| 60 | NCT01808482 (ClinicalTrials.gov) | March 13, 2013 | 7/3/2013 | A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A First Time in Human Study Exploring Preliminary Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Part A: 100 mg/mL GSK2618960;Drug: Part A: matching placebo;Drug: Part B: Dose of GSK2618960 decided from Part A;Drug: Part B: matching placebo;Drug: Part C: Dose of GSK2618960 decided from Part A and B | GlaxoSmithKline | NULL | Terminated | 18 Years | 55 Years | Male | 16 | Phase 1 | United Kingdom |
| 61 | EUCTR2012-003627-38-CZ (EUCTR) | 18/02/2013 | 12/11/2012 | Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 114 | Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden | |||
| 62 | EUCTR2012-003627-38-BG (EUCTR) | 01/02/2013 | 21/11/2012 | Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 114 | Phase 2 | Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden | ||
| 63 | NCT01772199 (ClinicalTrials.gov) | February 2013 | 17/1/2013 | Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK239512;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 50 Years | Both | 131 | Phase 2 | Bulgaria;Canada;Czech Republic;Germany;Spain;Sweden;Ukraine;United Kingdom |
| 64 | EUCTR2012-003627-38-SE (EUCTR) | 30/01/2013 | 10/09/2012 | Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 114 | Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden | |||
| 65 | EUCTR2012-003627-38-DE (EUCTR) | 24/01/2013 | 27/09/2012 | Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 15.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 114 | Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden | |||
| 66 | EUCTR2012-003627-38-GB (EUCTR) | 15/01/2013 | 21/11/2012 | Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 114 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden | ||
| 67 | NCT01802931 (ClinicalTrials.gov) | January 7, 2013 | 4/1/2013 | GSK239512 DDI Study | An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK239512 | Multiple Sclerosis | Drug: GSK239512;Drug: ketoconazole | GlaxoSmithKline | NULL | Completed | 18 Years | 45 Years | Male | 22 | Phase 1 | Australia |
| 68 | EUCTR2012-003627-38-ES (EUCTR) | 17/12/2012 | 02/10/2012 | Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: GSK2395612 INN or Proposed INN: GSK239512 Product Code: GSK239512 INN or Proposed INN: GSK239512 Product Code: GSK239512 INN or Proposed INN: GSK239512 Product Code: GSK239512 INN or Proposed INN: GSK239512 | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 114 | Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden | |||
| 69 | EUCTR2011-001437-16-DE (EUCTR) | 19/09/2012 | 09/02/2012 | A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosis | A 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis | multiple sclerosis MedDRA version: 15.0;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] | Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia INN or Proposed INN: Interferon beta-1b Other descriptive name: INTERFERON BETA-1B Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Spain;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands | ||
| 70 | NCT01633112 (ClinicalTrials.gov) | August 9, 2012 | 29/6/2012 | MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone | A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis (RRMS) | Drug: fingolimod;Drug: glatiramer acetate | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 1064 | Phase 3 | United States;Argentina;Brazil;Canada;Chile;Mexico;Puerto Rico |
| 71 | 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 | |||
| 72 | 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 | |||
| 73 | 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 | |||
| 74 | 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 | |||
| 75 | 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 | |||
| 76 | EUCTR2011-002333-19-IT (EUCTR) | 19/03/2012 | 14/03/2012 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS). - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS). MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra INN or Proposed INN: OFATUMUMAB Other descriptive name: NA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy | |||
| 77 | NCT01404117 (ClinicalTrials.gov) | March 2012 | 26/7/2011 | A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability | Relapsing Multiple Sclerosis | Drug: Laquinimod 0.6;Drug: Laquinimod 1.2;Other: Glatiramer Acetate or interferon-beta+ Placebo | Teva Pharmaceutical Industries | NULL | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 2 | NULL | |
| 78 | 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 |
| 79 | EUCTR2011-002333-19-CZ (EUCTR) | 27/02/2012 | 31/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Norway;Italy | |||
| 80 | NCT01569451 (ClinicalTrials.gov) | February 2012 | 30/3/2012 | Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate | A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Rituximab;Drug: Glatiramer Acetate;Other: Placebo | University of Colorado, Denver | Rocky Mountain MS Research Group, LLC | Completed | 18 Years | 55 Years | All | 53 | Phase 2 | United States |
| 81 | EUCTR2011-000888-27-DE (EUCTR) | 24/01/2012 | 19/08/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis 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: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 82 | EUCTR2011-000888-27-GR (EUCTR) | 09/01/2012 | 13/12/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.0;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: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 83 | 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 |
| 84 | NCT01498887 (ClinicalTrials.gov) | December 24, 2011 | 19/12/2011 | Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy | A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod (FTY720) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 50 Years | All | 347 | Phase 4 | Australia;Spain |
| 85 | NCT02967380 (ClinicalTrials.gov) | December 14, 2011 | 13/9/2015 | Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases | Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions | Adult Anaplastic (Malignant) Meningioma;Adult Anaplastic Astrocytoma;Adult Anaplastic Ependymoma;Adult Anaplastic Oligodendroglioma;Adult Brain Stem Glioma;Adult Choroid Plexus Neoplasm;Adult Diffuse Astrocytoma;Adult Ependymoblastoma;Adult Ependymoma;Adult Giant Cell Glioblastoma;Adult Glioblastoma;Adult Gliosarcoma;Adult Grade II Meningioma;Adult Medulloblastoma;Adult Mixed Glioma;Adult Oligodendroglioma;Adult Papillary Meningioma;Adult Pineal Gland Astrocytoma;Adult Pineoblastoma;Adult Primary Melanocytic Lesion of Meninges;Adult Supratentorial Primitive Neuroectodermal Tumor;Malignant Adult Intracranial Hemangiopericytoma;Metastatic Malignant Neoplasm in the Brain;Multiple Sclerosis;Recurrent Adult Brain Neoplasm | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging;Drug: Gadobenate Dimeglumine;Drug: Gadobutrol;Radiation: Gadopentetate Dimeglumine | University of Southern California | National Cancer Institute (NCI) | Terminated | 18 Years | N/A | All | 14 | N/A | United States |
| 86 | EUCTR2011-002333-19-DE (EUCTR) | 29/11/2011 | 09/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 15.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Norway;Germany;Italy | |||
| 87 | EUCTR2011-002333-19-DK (EUCTR) | 25/11/2011 | 18/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 2 | United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy | ||
| 88 | EUCTR2011-002333-19-NL (EUCTR) | 23/11/2011 | 05/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Germany;Norway;Netherlands;Italy | |||
| 89 | EUCTR2011-000888-27-RO (EUCTR) | 18/11/2011 | 09/10/2012 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 15.0;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: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | ||
| 90 | NCT01457924 (ClinicalTrials.gov) | November 1, 2011 | 20/10/2011 | Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Ofatumumab 3mg;Drug: Ofatumumab 30mg;Drug: Ofatumumab 60mg;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 232 | Phase 2 | United States;Bulgaria;Canada;Czechia;Denmark;Germany;Italy;Netherlands;Norway;Russian Federation;Spain;Czech Republic |
| 91 | EUCTR2011-003484-30-ES (EUCTR) | 26/10/2011 | 12/04/2012 | A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis. | A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis. - Earlims | Multiple Sclerosis relapsing-remitting course;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: Fingolimod | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 432 | Phase 3 | Spain;Australia | ||
| 92 | EUCTR2011-000888-27-GB (EUCTR) | 24/10/2011 | 01/08/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis 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: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 93 | EUCTR2011-002333-19-ES (EUCTR) | 21/10/2011 | 28/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months? administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline SA | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 2 | United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy | ||
| 94 | EUCTR2011-000888-27-IT (EUCTR) | 13/10/2011 | 24/01/2012 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: glatiramer acetate | SYNTHON BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Estonia;Czech Republic;Greece;Ukraine;Romania;Croatia;Bulgaria;Russian Federation;Germany;United Kingdom;Italy | |||
| 95 | NCT01489254 (ClinicalTrials.gov) | October 2011 | 8/12/2011 | Efficacy and Safety of GTR in Comparison to Copaxone® | Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects | Multiple Sclerosis | Drug: Glatiramer Acetate (GTR);Drug: Glatiramer Acetate (Copaxone®);Drug: Placebo | Synthon BV | NULL | Completed | 18 Years | 55 Years | All | 794 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Ukraine;United Kingdom;Greece;Kazakhstan |
| 96 | EUCTR2011-000888-27-EE (EUCTR) | 21/09/2011 | 01/09/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 15.0;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: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 97 | EUCTR2011-000888-27-CZ (EUCTR) | 21/09/2011 | 17/06/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis 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: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 98 | NCT01435993 (ClinicalTrials.gov) | September 8, 2011 | 25/8/2011 | Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis | A Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis. | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK1223249;Other: Saline placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | 60 Years | All | 3 | Phase 1 | Italy;Norway;Germany |
| 99 | EUCTR2011-000888-27-BG (EUCTR) | 18/08/2011 | 11/07/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis 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: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 100 | NCT01416363 (ClinicalTrials.gov) | May 20, 2011 | 23/6/2011 | Healthy Volunteer Study Using 3 Different Formulations of Firategrast | A Single/Repeat Dose Study With Three Oral Formulations of Firategrast (Immediate Release Tablet, Modified Release Tablet, and Naso-gastric Infusion) in Healthy Male Volunteers | Multiple Sclerosis, Relapsing-Remitting | Drug: Firategrast immediate release tablet;Drug: Firategrast modified release tablet;Drug: Firategrast gastro-retentive solution | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Male | 38 | Phase 1 | Australia |
| 101 | EUCTR2011-000150-31-IT (EUCTR) | 13/04/2011 | 28/12/2011 | EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY. | EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY. | Multiple Sclerosis patients MedDRA version: 14.1;Level: HLGT;Classification code 10012303;Term: Demyelinating disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate | FONDAZIONE DON CARLO GNOCCHI ONLUS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 102 | EUCTR2010-024017-31-IT (EUCTR) | 15/03/2011 | 08/02/2011 | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: FINGOLIMOD Product Code: FTY720D Trade Name: EXTAVIA INN or Proposed INN: Interferon beta-1b Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 103 | EUCTR2010-023021-38-SE (EUCTR) | 23/02/2011 | 26/11/2010 | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB | Västerbottens läns landsting | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 104 | NCT01454791 (ClinicalTrials.gov) | January 2011 | 9/8/2011 | Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate | Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial | Multiple Sclerosis | Drug: diclofenac sodium topical gel;Other: Placebo | Brown, Theodore R., M.D., MPH | Teva Neuroscience, Inc. | Completed | 18 Years | N/A | All | 40 | Phase 4 | United States |
| 105 | NCT01466322 (ClinicalTrials.gov) | December 22, 2010 | 3/11/2011 | A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers. | An Open-label, Randomised, Crossover Study to Assess the Relative Bioavailability of Different 2mg Formulations of GSK2018682(S1P1 Agonist) in Healthy Volunteers | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 16 | Phase 1 | Australia |
| 106 | EUCTR2009-015556-15-AT (EUCTR) | 19/11/2010 | 07/06/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 107 | NCT00939549 (ClinicalTrials.gov) | November 2010 | 14/7/2009 | High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis | Phase II Study of High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Cyclophosphamide/Glatiramer acetate | Johns Hopkins University | NULL | Withdrawn | 18 Years | 70 Years | All | 0 | Phase 2 | United States |
| 108 | NCT01431937 (ClinicalTrials.gov) | October 10, 2010 | 11/8/2011 | Assessment of Repeat Ascending Doses of GSK2018682 in Healthy Volunteers | A Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Ascending Doses of GSK2018682 (S1P1 Agonist) in Healthy Volunteers | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK2018682;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 40 | Phase 1 | Australia |
| 109 | EUCTR2009-015556-15-GB (EUCTR) | 02/09/2010 | 17/03/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 110 | EUCTR2009-015556-15-DK (EUCTR) | 25/08/2010 | 17/06/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden | |||
| 111 | EUCTR2009-015556-15-DE (EUCTR) | 20/08/2010 | 19/03/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 112 | EUCTR2009-015556-15-NL (EUCTR) | 13/08/2010 | 08/04/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 113 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Poland;Croatia;Romania;South Africa;Georgia;Bulgaria;Germany;United States;Estonia;Ukraine;Lithuania;Israel | ||
| 114 | 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 | ||
| 115 | EUCTR2009-015556-15-HU (EUCTR) | 14/07/2010 | 07/04/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Hungary;Portugal;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 116 | EUCTR2009-015556-15-GR (EUCTR) | 13/07/2010 | 14/12/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 117 | EUCTR2009-012716-40-PL (EUCTR) | 06/07/2010 | 11/01/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 118 | EUCTR2009-015556-15-PT (EUCTR) | 02/07/2010 | 30/03/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden | |||
| 119 | EUCTR2009-016087-37-IT (EUCTR) | 02/07/2010 | 21/07/2010 | A multinational, multicenter, single blood samplingexploratory pharmacogenetic study of the REGARD (theREbif vs Glatiramer Acetate in Relapsing MS Disease)trial - REGARD PGx | A multinational, multicenter, single blood samplingexploratory pharmacogenetic study of the REGARD (theREbif vs Glatiramer Acetate in Relapsing MS Disease)trial - REGARD PGx | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245 | Trade Name: REBIF INN or Proposed INN: Interferon beta-1a | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 325 | United Kingdom;France;Ireland;Spain;Italy | |||
| 120 | 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 |
| 121 | NCT01067521 (ClinicalTrials.gov) | June 22, 2010 | 10/2/2010 | 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 | 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 Branded Pharmaceutical Products R&D, Inc. | 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 |
| 122 | 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 | ||
| 123 | EUCTR2009-015556-15-LV (EUCTR) | 11/06/2010 | 13/04/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 13.1;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] | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Sweden | |||
| 124 | EUCTR2009-015556-15-CZ (EUCTR) | 10/06/2010 | 29/03/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 13.1;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] | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;Sweden | |||
| 125 | EUCTR2009-015556-15-SI (EUCTR) | 07/06/2010 | 12/04/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.0;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] | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States | |||
| 126 | EUCTR2009-015556-15-IT (EUCTR) | 07/06/2010 | 07/06/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Trade Name: TYSABRI INN or Proposed INN: Natalizumab Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate Trade Name: REBIF INN or Proposed INN: Interferon beta-1a Trade Name: REBIF*SC 12SIR 6000000UI 22MCG INN or Proposed INN: Interferon beta-1a | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 127 | 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 | ||
| 128 | 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 |
| 129 | EUCTR2009-012716-40-DE (EUCTR) | 28/05/2010 | 16/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | France;Czech Republic;Estonia;Slovakia;Poland;Bulgaria;Germany | ||
| 130 | 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 | ||
| 131 | EUCTR2009-015556-15-ES (EUCTR) | 24/05/2010 | 24/03/2010 | Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: TYSABRI 300 mg concentrado para solución para perfusión INN or Proposed INN: NATALIZUMAB Other descriptive name: NATALIZUMAB Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada INN or Proposed INN: GLATIRAMERO ACETATO Other descriptive name: GLATIRAMER ACETATE Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 132 | NCT01387217 (ClinicalTrials.gov) | May 21, 2010 | 14/4/2011 | GSK2018682 FTIH in Healthy Volunteers | A Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy Volunteers | Multiple Sclerosis | Drug: GSK2018682;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 27 | Phase 1 | Australia |
| 133 | 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 | ||
| 134 | 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 | ||
| 135 | EUCTR2009-015556-15-FI (EUCTR) | 07/05/2010 | 24/02/2010 | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA-1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 136 | EUCTR2009-015556-15-SE (EUCTR) | 06/05/2010 | 09/03/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 13.1;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] | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack. INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden | |||
| 137 | EUCTR2009-017490-38-DE (EUCTR) | 03/05/2010 | 01/02/2010 | Randomized Treatment Interruption of Natalizumab - RESTORE | Randomized Treatment Interruption of Natalizumab - RESTORE | Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months. MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: TYSABRI Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: COPAXONE Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: AVONEX Trade Name: Urbason Forte INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: URBASON FORTE | Biogen Idec | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Spain | |||
| 138 | EUCTR2009-012716-40-BG (EUCTR) | 01/04/2010 | 08/04/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;France;Estonia;Bulgaria;Poland | ||
| 139 | 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 | ||
| 140 | EUCTR2009-011088-35-DE (EUCTR) | 24/03/2010 | 05/02/2010 | Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS | Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS | Patients with Multiple Sclerosis (MS) or Clinically isolated syndrome suggestive for MS (CIS) are investigated. The main objective is to conserve data about changes in the VIP/PACAP (vasoactive intestinal polypaptide/pituitary adenylate cyclase activating polypeptide) system in stresses patients who start a immunomodulatory treatment with glatiramer acetate (Copaxone). | Trade Name: Copaxone Product Name: copaxone Product Code: 52069.00.01 INN or Proposed INN: glatiramer acetate | Philipps-Universität Marburg | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany | ||
| 141 | EUCTR2009-012716-40-CZ (EUCTR) | 10/03/2010 | 08/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 142 | EUCTR2009-012716-40-FR (EUCTR) | 03/03/2010 | 28/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;Estonia;France;Poland | ||
| 143 | NCT01071083 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | Treatment Interruption of Natalizumab | Randomized Treatment Interruption of Natalizumab | Relapsing Remitting Multiple Sclerosis | Drug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetate | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 60 Years | All | 175 | Phase 2 | United States;Germany;Spain |
| 144 | NCT01058005 (ClinicalTrials.gov) | March 2010 | 26/1/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BG00002 (natalizumab);Drug: interferon beta-1a;Drug: glatiramer acetate | Biogen | Elan Pharmaceuticals | Terminated | 18 Years | 60 Years | All | 84 | Phase 3 | United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden |
| 145 | NCT01424423 (ClinicalTrials.gov) | February 11, 2010 | 9/6/2011 | NOGO-A in Multiple Sclerosis FTIH | A Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying Therapy | Multiple Sclerosis | Drug: Placebo;Drug: GSK1223249 | GlaxoSmithKline | NULL | Terminated | 18 Years | 55 Years | All | 3 | Phase 1 | Australia |
| 146 | EUCTR2009-016087-37-GB (EUCTR) | 05/02/2010 | 17/03/2010 | A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx | A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx | Multiple Sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif Product Name: Rebif INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 325 | United Kingdom;France;Ireland;Spain;Italy | |||
| 147 | EUCTR2009-012716-40-SK (EUCTR) | 03/02/2010 | 19/01/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | France;Czech Republic;Estonia;Slovakia;Poland;Bulgaria;Germany | ||
| 148 | NCT00988988 (ClinicalTrials.gov) | February 2010 | 30/9/2009 | The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections | The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate | Multiple Sclerosis | Drug: AGEE cream;Drug: 1% Steroid Cream;Drug: topical placebo cream with no active ingredients | University of Nebraska | Teva Pharmaceutical Industries | Withdrawn | 19 Years | 65 Years | Both | 0 | Phase 4 | United States |
| 149 | EUCTR2009-012716-40-EE (EUCTR) | 31/12/2009 | 07/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 150 | EUCTR2009-016087-37-ES (EUCTR) | 18/12/2009 | 24/11/2009 | Estudio farmacogenético exploratorio, multinacional, multicéntrico y con una sola toma de muestras de sangre del ensayo REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease). A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx | Estudio farmacogenético exploratorio, multinacional, multicéntrico y con una sola toma de muestras de sangre del ensayo REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease). A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx | Esclerosis Múltiple MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Rebif Product Name: Copaxone | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 325 | United Kingdom;France;Ireland;Spain;Italy | |||
| 151 | NCT00910598 (ClinicalTrials.gov) | September 2009 | 29/5/2009 | Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS) | A Multicenter Longitudinal Cross-sectional Pilot Study, to Compare RNFL Thickness Measured by OCT After Treatment With Glatiramer or After no Treatment in Patients With CIS With or Without Optic Neuritis or With Early RRMS | Multiple Sclerosis | Drug: glatiramer acetate | Amphia Hospital | Sanofi;TEVA Pharmachemie | Recruiting | 18 Years | 55 Years | Both | 60 | Phase 4 | Netherlands |
| 152 | EUCTR2009-010661-23-IT (EUCTR) | 30/07/2009 | 10/01/2011 | MITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDY | MITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDY | subjects affected by secondary-progressive Multiple Sclerosis MedDRA version: 9.1;Level: SOC;Classification code 10029205 | INN or Proposed INN: Mitoxantrone INN or Proposed INN: Glatiramer acetate | AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 153 | EUCTR2009-013129-41-NL (EUCTR) | 20/07/2009 | 03/06/2009 | A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT | A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT | clinical isolated syndrome MedDRA version: 9.1;Level: LLT;Classification code 10028248;Term: Multiple sclerosis-like syndrome | Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Amphia Ziekenhuis | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 154 | 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 |
| 155 | EUCTR2006-001827-21-DK (EUCTR) | 06/03/2009 | 15/01/2009 | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/Copaxone | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/Copaxone | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Simvastatin Trade Name: Copaxone Product Name: Glatiramer acetate | Glostrup Hospital, Dep. of Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Denmark | ||||
| 156 | EUCTR2007-004223-38-GB (EUCTR) | 05/01/2009 | 26/11/2007 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline UK | NULL | Not Recruiting | Female: yes Male: yes | 57 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 157 | NCT00819000 (ClinicalTrials.gov) | December 2008 | 7/1/2009 | Therapy Optimization in Multiple Sclerosis (MS) | TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies | Multiple Sclerosis | Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | N/A | Both | 2878 | N/A | United States |
| 158 | NCT00819195 (ClinicalTrials.gov) | December 2008 | 16/12/2008 | Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis | Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis | Multiple Sclerosis | Drug: Glatiramer acetate | University of California, San Francisco | National Multiple Sclerosis Society;Teva Neuroscience, Inc. | Completed | 18 Years | 55 Years | Both | 17 | N/A | United States |
| 159 | EUCTR2006-003697-10-BG (EUCTR) | 14/08/2008 | 14/06/2008 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Estonia;Bulgaria;Ireland;Spain;Greece;Latvia | |||
| 160 | EUCTR2007-003997-24-GB (EUCTR) | 08/07/2008 | 20/08/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 161 | EUCTR2007-003997-24-IT (EUCTR) | 05/06/2008 | 13/06/2008 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-Aventis recherche & de'veloppement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 162 | EUCTR2007-004223-38-SE (EUCTR) | 05/05/2008 | 13/03/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline AB | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;Czech Republic;United Kingdom;Denmark;Sweden | |||
| 163 | NCT00640328 (ClinicalTrials.gov) | May 2008 | 18/3/2008 | Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | Multiple Sclerosis | Drug: Ofatumumab 100;Drug: Ofatumumab 300;Drug: Ofatumumab 700;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 38 | Phase 2 | Belgium;Czech Republic;Denmark;Former Serbia and Montenegro;Germany;Poland;Serbia;Sweden;United Kingdom |
| 164 | EUCTR2007-004223-38-DK (EUCTR) | 04/04/2008 | 23/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 57 | Czech Republic;Denmark;Germany;United Kingdom;Sweden | |||
| 165 | EUCTR2007-004223-38-CZ (EUCTR) | 27/02/2008 | 02/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline s.r.o. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;United Kingdom;Czech Republic;Denmark;Sweden | |||
| 166 | EUCTR2007-003997-24-ES (EUCTR) | 26/11/2007 | 15/10/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Multiple Sclerosis.-----------------------Esclerosis Múltiple. | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 167 | EUCTR2008-007162-32-IT (EUCTR) | 30/10/2007 | 06/11/2008 | ADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSM | ADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSM | Multiple Sclerosis MedDRA version: 9.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders | Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a | ISTITUTO C. MONDINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 168 | EUCTR2006-003697-10-GR (EUCTR) | 30/10/2007 | 31/05/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 169 | EUCTR2007-003997-24-AT (EUCTR) | 14/10/2007 | 21/09/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 170 | EUCTR2006-003697-10-DE (EUCTR) | 04/10/2007 | 06/04/2009 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Czech Republic;Germany;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 171 | NCT00811395 (ClinicalTrials.gov) | October 2007 | 18/12/2008 | Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA] | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 182 | Phase 2 | United States;Austria;Canada;Germany;Italy;Spain;United Kingdom |
| 172 | EUCTR2006-004893-29-IT (EUCTR) | 24/09/2007 | 24/07/2007 | 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 - ND | 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 - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;United Kingdom;Italy;Austria | |||
| 173 | EUCTR2006-003697-10-EE (EUCTR) | 18/09/2007 | 12/06/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 174 | EUCTR2006-002633-20-LT (EUCTR) | 07/09/2007 | 05/07/2007 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 175 | 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 |
| 176 | EUCTR2006-003697-10-ES (EUCTR) | 29/08/2007 | 28/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A | Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: glatiramer acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Phase 3 | Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Latvia | ||
| 177 | EUCTR2006-003697-10-LV (EUCTR) | 22/08/2007 | 26/07/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 178 | EUCTR2006-004893-29-GB (EUCTR) | 25/07/2007 | 17/12/2006 | 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 | 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 | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Austria;Germany;Italy;United Kingdom | ||
| 179 | EUCTR2006-003697-10-BE (EUCTR) | 13/07/2007 | 23/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Phase 3 | Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;Latvia | ||
| 180 | EUCTR2006-002633-20-FR (EUCTR) | 04/07/2007 | 11/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 181 | EUCTR2006-003697-10-IE (EUCTR) | 04/07/2007 | 20/03/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Ireland;Greece;Latvia | |||
| 182 | 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 | |||
| 183 | NCT00469378 (ClinicalTrials.gov) | July 2007 | 2/5/2007 | Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple Sclerosis | An Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With Firategrast | Multiple Sclerosis | Drug: firategrast | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 46 | Phase 2 | Belgium;Czech Republic;Denmark;Norway;Sweden |
| 184 | EUCTR2006-007057-42-DK (EUCTR) | 25/06/2007 | 14/05/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Denmark;Sweden | |||
| 185 | NCT00451451 (ClinicalTrials.gov) | June 2007 | 21/3/2007 | Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: BG00012;Drug: Placebo;Drug: Glatiramer Acetate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 1417 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Costa Rica;Croatia;Czech Republic;Estonia;France;Germany;Greece;India;Ireland;Israel;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;New Zealand;Poland;Puerto Rico;Romania;Serbia;Slovakia;Spain;Ukraine;Australia;Italy;Kazakhstan;Lithuania;Russian Federation |
| 186 | EUCTR2006-007057-42-BE (EUCTR) | 29/05/2007 | 14/02/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Belgium;Denmark;Sweden | |||
| 187 | EUCTR2006-007057-42-CZ (EUCTR) | 03/05/2007 | 16/03/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Belgium;Denmark;Sweden | ||
| 188 | EUCTR2006-007057-42-SE (EUCTR) | 02/05/2007 | 15/02/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Denmark;Sweden | |||
| 189 | NCT00548769 (ClinicalTrials.gov) | April 21, 2007 | 23/10/2007 | Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients | An Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple Sclerosis | Multiple Sclerosis | Drug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation D | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 37 | Phase 1 | Czechia;Germany;Poland;Czech Republic |
| 190 | EUCTR2006-003697-10-CZ (EUCTR) | 13/04/2007 | 23/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 191 | 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 |
| 192 | EUCTR2006-002633-20-IT (EUCTR) | 26/03/2007 | 05/02/2007 | Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | |||
| 193 | EUCTR2006-004893-29-AT (EUCTR) | 19/03/2007 | 08/03/2007 | 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 | 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 | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;United Kingdom;Italy;Austria | |||
| 194 | EUCTR2006-003134-14-ES (EUCTR) | 23/02/2007 | 26/10/2009 | 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 interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | 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 interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | Multiple sclerosis.Esclerosis Múltiple. | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Spain;Germany;Italy | ||
| 195 | EUCTR2006-002037-20-EE (EUCTR) | 02/02/2007 | 04/12/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 196 | EUCTR2006-002633-20-GB (EUCTR) | 25/01/2007 | 10/02/2012 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 197 | EUCTR2006-002633-20-FI (EUCTR) | 05/12/2006 | 04/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 198 | EUCTR2006-002633-20-ES (EUCTR) | 01/12/2006 | 13/04/2012 | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Esclerosis múltiple remitente-recurrente 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: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline S.A | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Finland;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Norway;New Zealand | ||
| 199 | NCT00395317 (ClinicalTrials.gov) | December 2006 | 1/11/2006 | Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS) | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Other: Placebo;Drug: Firategrast 150 mg;Drug: Firategrast 300 mg | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 343 | Phase 2 | Australia;Austria;Canada;Finland;France;Germany;Italy;Netherlands;New Zealand;Norway;Poland;Russian Federation;Spain;United Kingdom;Lithuania |
| 200 | EUCTR2006-002037-20-LT (EUCTR) | 30/11/2006 | 09/10/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 201 | EUCTR2006-002633-20-NL (EUCTR) | 17/11/2006 | 10/08/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 202 | EUCTR2006-002633-20-DE (EUCTR) | 25/10/2006 | 23/08/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy | |||
| 203 | EUCTR2006-002037-20-CZ (EUCTR) | 13/10/2006 | 28/08/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 204 | EUCTR2006-002633-20-AT (EUCTR) | 05/10/2006 | 14/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 205 | EUCTR2006-002037-20-BE (EUCTR) | 27/09/2006 | 19/07/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 206 | EUCTR2006-002037-20-GB (EUCTR) | 07/09/2006 | 23/07/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 207 | EUCTR2006-002037-20-DE (EUCTR) | 07/09/2006 | 20/10/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Czech Republic;United Kingdom;Germany;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 208 | EUCTR2006-002037-20-LV (EUCTR) | 06/09/2006 | 23/08/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 209 | EUCTR2006-002037-20-ES (EUCTR) | 06/09/2006 | 07/07/2006 | A 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) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE | A 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) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - 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 acetato Trade Name: Copaxone 20 mg/ml solución para inyección en jeringa precargada Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: GLATIRAMERO ACETATO Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom | ||
| 210 | NCT00398528 (ClinicalTrials.gov) | September 2006 | 9/11/2006 | An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis | An fMRI Study of Treatment Optimization Recommendations Comparing Patients Changing Treatment From Glatiramer Acetate 20 mg qd SC (Copaxone®) to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Those Changing From to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Glatiramer Acetate 20 mg qd SC (Copaxone®) in a Multicenter Study of Patients With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy. | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer acetate, (Copaxone®);Drug: IFN-ß-1a, (Avonex®) | Neurognostics | NULL | Terminated | 18 Years | 65 Years | Both | 48 | United States | |
| 211 | 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 |
| 212 | EUCTR2006-002037-20-HU (EUCTR) | 27/07/2006 | 23/05/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 213 | EUCTR2006-002037-20-IT (EUCTR) | 12/07/2006 | 30/08/2006 | 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 . - FORTE | 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 . - 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 214 | EUCTR2006-002037-20-FI (EUCTR) | 12/07/2006 | 15/06/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Phase 3 | Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom | ||
| 215 | NCT00331747 (ClinicalTrials.gov) | May 2006 | 30/5/2006 | Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate | Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate | Multiple Sclerosis | Drug: Glatiramer acetate | Sheba Medical Center | NULL | Recruiting | 18 Years | N/A | Both | 20 | N/A | Israel |
| 216 | EUCTR2005-003930-16-SE (EUCTR) | 19/01/2006 | 21/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 217 | EUCTR2005-003930-16-FI (EUCTR) | 05/01/2006 | 29/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who have been prescribed treatment with Avonex. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Trade Name: Simvastatin Alternova Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 218 | EUCTR2005-003930-16-DK (EUCTR) | 09/12/2005 | 05/12/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Denmark;Sweden | |||
| 219 | NCT00239993 (ClinicalTrials.gov) | August 2005 | 22/9/2005 | A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone® | An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®. | Multiple Sclerosis | Drug: glatiramer acetate;Procedure: Warm compress prior to injection of glatiramer acetate | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | 55 Years | All | 50 | Phase 4 | United States |
| 220 | EUCTR2004-004903-39-GB (EUCTR) | 26/07/2005 | 14/06/2005 | A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPT | A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPT | Early, active relapsing remitting Multiple Sclerosis (RRMS) | Trade Name: Mitoxantrone Product Name: Mitoxantrone Trade Name: Copaxone Product Name: Glatiramer Acetate Trade Name: Rebif 44 Product Name: Interferon Beta 1a | The Walton Centre for Neurology and Neurosurgery | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 221 | 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 |
| 222 | NCT00211887 (ClinicalTrials.gov) | January 2005 | 13/9/2005 | Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx | A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) | Relapsing Remitting Multiple Sclerosis | Drug: Interferon beta 1-a;Drug: glatiramer acetate;Other: placebo | Fred Lublin | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 60 Years | All | 1008 | Phase 3 | United States;Canada |
| 223 | 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 |
| 224 | NCT00101959 (ClinicalTrials.gov) | November 2004 | 18/1/2005 | Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) Subjects | An Implementation Study of Treatment Optimization Recommendations Comparing Subjects Continuing Treatment With IFN-ß-1a 30 Mcg qw IM (Avonex®) or Glatiramer Acetate 20 mg qd SC (Copaxone®) to Those Randomized to IFN-ß-1a 44 Mcg Tiw SC (Rebif®), in a Multicenter Study of Subjects With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy | Relapsing-Remitting Multiple Sclerosis | Drug: Rebif | EMD Serono | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 4 | United States |
| 225 | EUCTR2004-000759-40-IT (EUCTR) | 22/10/2004 | 15/02/2005 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | 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: TV-5010 INN or Proposed INN: Glatiramer acetate | TEVA | NULL | Not Recruiting | Female: yes Male: yes | 25 | Italy | |||
| 226 | 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 | |||
| 227 | NCT00240032 (ClinicalTrials.gov) | October 2004 | 13/10/2005 | A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®. | A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe. | Multiple Sclerosis | Drug: glatiramer acetate injection with oral cetirizine hydrochloride;Drug: glatiramer acetate with placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | N/A | Both | 80 | Phase 4 | United States |
| 228 | NCT00097331 (ClinicalTrials.gov) | September 2004 | 22/11/2004 | Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Three Months Administration of SB-683699 (150 - 1200mg Twice Daily) in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: SB683699 | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 261 | Phase 2 | Belgium;Germany;Poland;Russian Federation;Spain;United States;Canada;France;Italy;Romania |
| 229 | EUCTR2004-000762-13-IT (EUCTR) | 31/08/2004 | 31/08/2012 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit. MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Glatiramer acetate Product Code: TV-5010 INN or Proposed INN: Glatiramer acetate | TEVA ITALIA srl | NULL | Not Recruiting | Female: yes Male: yes | 7 | Phase 2 | Italy | ||
| 230 | 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 | ||||
| 231 | 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 | |||
| 232 | NCT00202995 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS | A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Betaseron;Drug: Rebif | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 50 Years | Both | 91 | Phase 4 | United States;Canada |
| 233 | EUCTR2004-000374-31-IT (EUCTR) | 09/06/2004 | 26/08/2004 | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple Sclerosis | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Trade Name: ALTRI FARMACI DEL SISTEMA NERVOSO Product Name: NA Product Code: aSB-683699 | GLAXO SMITHKLINE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 234 | 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 |
| 235 | NCT00078338 (ClinicalTrials.gov) | March 2004 | 23/2/2004 | Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis | Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Human interferon beta-1a and glatiramer acetate | EMD Serono | Pfizer | Completed | 18 Years | 60 Years | Both | 764 | Phase 4 | United States;Argentina;Austria;Brazil;France;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;United Kingdom |
| 236 | NCT00666224 (ClinicalTrials.gov) | January 2004 | 22/4/2008 | Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome | A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS) | Multiple Sclerosis | Drug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL) | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 45 Years | All | 481 | Phase 3 | Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States |
| 237 | NCT00202982 (ClinicalTrials.gov) | August 2003 | 12/9/2005 | A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose | A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients | Relapse-Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mg | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 90 | Phase 2 | United States |
| 238 | 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 |
| 239 | 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 |
| 240 | NCT00267319 (ClinicalTrials.gov) | June 2003 | 19/12/2005 | FOCUS Fatigue Outcome in Copaxone USers | Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Glatiramer acetate | Sanofi | NULL | Completed | 18 Years | N/A | Both | 111 | Phase 4 | Czech Republic |
| 241 | NCT00039988 (ClinicalTrials.gov) | November 2001 | 18/6/2002 | Treatment of Multiple Sclerosis With Copaxone and Albuterol | Treatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate) and Albuterol | Autoimmune Diseases;Multiple Sclerosis | Drug: Glatiramer acetate;Drug: Albuterol;Drug: Albuterol placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Completed | 18 Years | 55 Years | Both | 40 | N/A | United States |
| 242 | NCT00203021 (ClinicalTrials.gov) | March 26, 1994 | 12/9/2005 | Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness | Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer acetate | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | N/A | All | 208 | Phase 4 | United States |
| 243 | EUCTR2006-004893-29-DE (EUCTR) | 06/02/2007 | 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 | 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 | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Austria;Germany;Italy;United Kingdom |
19. ライソゾーム病
臨床試験数 : 899 / 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
| 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 | NCT04020055 (ClinicalTrials.gov) | October 31, 2022 | 24/6/2019 | A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease | An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects With Fabry Disease and Amenable GLA Variants and Severe Renal Impairment or End-Stage Renal Disease Treated With Hemodialysis | Fabry Disease | Drug: migalastat HCl 150 mg | Amicus Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 14 | Phase 3 | United States;Australia;France;Japan;Spain;Belgium;Italy;United Kingdom |
| 2 | EUCTR2019-000222-21-GB (EUCTR) | 25/08/2020 | 12/06/2020 | Migalastat Pediatric Long Term Extension Study | A LONG-TERM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACODYNAMICS, AND EFFICACY OF MIGALASTAT IN SUBJECTS > 12 YEARS OF AGE WITH FABRY DISEASE AND AMENABLE GLA VARIANTS | Fabry disease and with amenable GLA variants MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Migalastat Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE | Amicus Therapeutics, UK Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;United Kingdom | ||
| 3 | EUCTR2017-000146-21-IT (EUCTR) | 30/01/2020 | 23/10/2020 | AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABLE GLA VARIANTS | AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABLE GLA VARIANTS - ASPIRE | Fabry disease and with amenable GLA variants MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Galafold Product Name: Migalastat Product Code: [AT1001] INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE | Amicus Therapeutics UK, Ltd | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Australia;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2017-000146-21-GB (EUCTR) | 29/08/2019 | 22/03/2019 | ASPIRE Paediatric Fabry Study | AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABLE GLA VARIANTS | Fabry disease and with amenable GLA variants MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Galafold Product Name: Migalastat Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE | Amicus Therapeutics, UK Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Australia;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2017-000146-21-ES (EUCTR) | 09/05/2019 | 11/04/2019 | ASPIRE Pediatric Fabry Study | AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABLE GLA VARIANTS | Fabry disease and with amenable GLA variants MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Galafold Product Name: Migalastat Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE | Amicus Therapeutics, UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Australia;Germany;United Kingdom;Italy | ||
| 6 | NCT03500094 (ClinicalTrials.gov) | October 11, 2018 | 9/4/2018 | Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years) | An Open-label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of 12 Month Treatment With Migalastat in Pediatric Subjects (Aged 12 to <18 Years) With Fabry Disease and Amenable GLA Variants | Fabry Disease | Drug: migalastat HCl 150 mg | Amicus Therapeutics | NULL | Completed | 12 Years | 17 Years | All | 22 | Phase 3 | United States;Spain;United Kingdom |
| 7 | NCT05056636 (ClinicalTrials.gov) | June 1, 2018 | 31/8/2021 | Epidemiological Study of Fabry Disease Screening in Chronic Kidney Disease Patients | Epidemiological Study of Fabry Disease Screening in Chronic Kidney Disease Patients | Fabry Disease | Diagnostic Test: Plasma a-Gal A activity; Plasma Lyso-GB3; GLA genetic sequencing. | Chang Gung Memorial Hospital | NULL | Recruiting | 18 Years | N/A | All | 2000 | Taiwan | |
| 8 | NCT03596398 (ClinicalTrials.gov) | January 1, 2016 | 15/6/2018 | Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients | Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients | Fabry Disease | Genetic: GLA gene | Chiayi Christian Hospital | Sanofi | Enrolling by invitation | 20 Years | 55 Years | All | 1000 | NULL | |
| 9 | EUCTR2014-002701-38-DK (EUCTR) | 15/05/2015 | 20/01/2015 | A Study Using Migalastat Hydrochloride to See the Long Term Safety and Effectiveness of the Drug in Patients with Fabry Disease | An Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in subjects with Fabry Disease | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: NA Other descriptive name: Inactive Reminder Capsules | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Turkey;Austria;United Kingdom;Italy;Egypt;France;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Japan | ||
| 10 | EUCTR2014-002701-38-ES (EUCTR) | 12/03/2015 | 16/01/2015 | A Study Using Migalastat Hydrochloride to See the Long Term Safety and Effectiveness of the Drug in Patients with Fabry Disease | An Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in subjects with Fabry Disease | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 17.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Turkey;Austria;Italy;United Kingdom;Egypt;France;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Japan | ||
| 11 | EUCTR2014-002701-38-BE (EUCTR) | 09/02/2015 | 04/12/2014 | A Study Using Migalastat Hydrochloride to See the Long Term Safety and Effectiveness of the Drug in Patients with Fabry Disease | An Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in subjects with Fabry Disease | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 18.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: NA Other descriptive name: Inactive Reminder Capsules | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Turkey;Austria;United Kingdom;Italy;Egypt;France;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Japan | ||
| 12 | EUCTR2014-002701-38-GB (EUCTR) | 28/01/2015 | 09/12/2014 | A Study Using Migalastat Hydrochloride to See the Long Term Safety and Effectiveness of the Drug in Patients with Fabry Disease | An Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in subjects with Fabry Disease | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 18.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: NA Other descriptive name: Inactive Reminder Capsules | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Turkey;Austria;United Kingdom;Italy;Egypt;France;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Japan | ||
| 13 | EUCTR2014-002701-38-AT (EUCTR) | 17/12/2014 | 12/11/2014 | A Study Using Migalastat Hydrochloride to See the Long Term Safety and Effectiveness of the Drug in Patients with Fabry Disease | An Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in subjects with Fabry Disease | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: NA Other descriptive name: Inactive Reminder Capsules | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Turkey;Austria;United Kingdom;Italy;Egypt;France;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Japan | ||
| 14 | EUCTR2011-004800-40-AT (EUCTR) | 08/07/2014 | 15/05/2014 | A Study using Migalastat to see the safety and usefulness of the drug in patients with Fabry Disease. | An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease. | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 17.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat Hydrochloride Product Code: AT1001 INN or Proposed INN: Migalastat Hydrochloride Other descriptive name: GR181413A | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Turkey;Austria;Italy;United Kingdom;Egypt;France;Canada;Argentina;Belgium;Brazil;Australia;Denmark | ||
| 15 | NCT01917708 (ClinicalTrials.gov) | January 2014 | 24/7/2013 | Bone Marrow Transplant With Abatacept for Non-Malignant Diseases | Abatacept for Post-Transplant Immune Suppression in Children and Adolescents Receiving Allogeneic Hematopoietic Stem Cell Transplants for Non-Malignant Diseases | Hurler Syndrome;Fanconi Anemia;Glanzmann Thrombasthenia;Wiskott-Aldrich Syndrome;Chronic Granulomatous Disease;Severe Congenital Neutropenia;Leukocyte Adhesion Deficiency;Shwachman-Diamond Syndrome;Diamond-Blackfan Anemia;Dyskeratosis-congenita;Chediak-Higashi Syndrome;Severe Aplastic Anemia;Thalassemia Major;Hemophagocytic Lymphohistiocytosis;Sickle Cell Disease | Drug: Abatacept | Emory University | NULL | Completed | N/A | 21 Years | All | 10 | Phase 1 | United States |
| 16 | EUCTR2011-004800-40-BE (EUCTR) | 07/10/2013 | 29/08/2013 | A Study using Migalastat to see the safety and usefulness of the drug in patients with Fabry Disease. | An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease. | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 17.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat Hydrochloride Product Code: AT1001 INN or Proposed INN: Migalastat Hydrochloride Other descriptive name: GR181413A | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Turkey;Austria;Italy;United Kingdom;Egypt;France;Canada;Argentina;Belgium;Brazil;Australia;Denmark | ||
| 17 | EUCTR2011-004800-40-DK (EUCTR) | 27/08/2012 | 13/07/2012 | A Study using Migalastat to see the safety and usefulness of the drug in patients with Fabry Disease. | An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease. | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 17.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat Hydrochloride Product Code: AT1001 INN or Proposed INN: Migalastat Hydrochloride Other descriptive name: GR181413A | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Turkey;Austria;Italy;United Kingdom;Egypt;France;Canada;Argentina;Belgium;Brazil;Denmark;Australia | ||
| 18 | EUCTR2011-004800-40-IT (EUCTR) | 15/05/2012 | 12/03/2012 | A Study using Migalastat to see the safety and usefulness of the drug in patients with Fabry Disease. | An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease. | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a- galactosidase A. MedDRA version: 14.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat Hydrochloride Product Code: GR181413 INN or Proposed INN: Migalastat Hydrochloride Other descriptive name: GR181413A | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Egypt;United States;Belgium;Spain;Brazil;Turkey;Austria;Denmark;Australia;United Kingdom;Italy | |||
| 19 | EUCTR2010-022636-37-DE (EUCTR) | 09/05/2012 | 10/01/2012 | The ATTRACT Study is a phase 3 clinical study that will measure theeffectiveness and safety of a new investigational medication, when compared to Enzyme Replacement Therapy, for the treatment of patients with Fabry disease | A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT - ATTRACT | Fabry disease MedDRA version: 15.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: Not applicable Trade Name: Replagal INN or Proposed INN: AGALSIDASE ALFA Trade Name: Fabrazyme INN or Proposed INN: AGALSIDASE BETA | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;Germany;Turkey;Switzerland;France;Italy;Austria;Australia;Brazil;Israel;United Kingdom;Slovakia;Russian Federation;Taiwan;Mexico;Argentina;Belgium;Denmark;Japan;United States;Greece;Poland | ||
| 20 | NCT01602601 (ClinicalTrials.gov) | April 9, 2012 | 17/5/2012 | A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723 | A Study to Test the Possibility of Cross Reaction of the Antibodies Induced by the ELAPRASE (R) to GSK2788723 ELAPRASE is a Trade Mark Owned by a Third Party | Mucopolysaccharidosis II | Drug: Idursulfase;Drug: GSK2788723 | GlaxoSmithKline | NULL | Completed | N/A | N/A | All | 10 | N/A | Japan |
| 21 | EUCTR2011-004800-40-ES (EUCTR) | 13/02/2012 | 11/01/2012 | A Study using Migalastat to see the safety and usefulness of the drug in patients with Fabry Disease. | An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease. | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme alfa-galactosidase A. MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat Hydrochloride Product Code: GR181413 INN or Proposed INN: Migalastat Hydrochloride Other descriptive name: GR181413A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;Egypt;United States;Belgium;Brazil;Spain;Turkey;Austria;Denmark;Australia;Italy;United Kingdom | ||
| 22 | EUCTR2011-004800-40-GB (EUCTR) | 25/01/2012 | 25/10/2011 | A Study using Migalastat to see the safety and usefulness of the drug in patients with Fabry Disease. | An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease. | Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. MedDRA version: 17.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Migalastat Hydrochloride Product Code: AT1001 INN or Proposed INN: Migalastat Hydrochloride Other descriptive name: GR181413A | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Turkey;Austria;Italy;United Kingdom;Egypt;France;Canada;Argentina;Belgium;Brazil;Australia;Denmark | ||
| 23 | EUCTR2010-022636-37-IT (EUCTR) | 16/12/2011 | 13/03/2012 | A Randomized, Open-Label, Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT - AT1001-012 | A Randomized, Open-Label, Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT - AT1001-012 | Fabry disease MedDRA version: 14.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrocloride Product Code: AT1001 INN or Proposed INN: migalastat hydrocloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Trade Name: REPLAGAL INN or Proposed INN: Agalsidase alfa Other descriptive name: NA Trade Name: FABRAZYME INN or Proposed INN: Agalsidase beta Other descriptive name: NA | AMICUS THERAPEUTICS, INC | NULL | Not Recruiting | Female: yes Male: yes | 50 | United States;Taiwan;Greece;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Mexico;Argentina;Brazil;Belgium;Denmark;Australia;Germany;Japan | |||
| 24 | EUCTR2010-022636-37-GR (EUCTR) | 02/11/2011 | 23/09/2011 | The ATTRACT Study is a phase 3 clinical study that will measure theeffectiveness and safety of a new investigational medication, when compared to Enzyme Replacement Therapy, for the treatment of patients with Fabry disease | A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT - ATTRACT | Fabry disease MedDRA version: 14.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: Not applicable Trade Name: Replagal INN or Proposed INN: AGALSIDASE ALFA Trade Name: Fabrazyme INN or Proposed INN: AGALSIDASE BETA | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;Taiwan;Slovakia;Greece;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Denmark;Australia;Germany;Japan | ||
| 25 | NCT01218659 (ClinicalTrials.gov) | September 8, 2011 | 6/10/2010 | Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease | A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT | Fabry Disease | Drug: migalastat hydrochloride;Biological: agalsidase | Amicus Therapeutics | NULL | Completed | 16 Years | 74 Years | All | 68 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Denmark;France;Italy;Japan;United Kingdom;Argentina;Germany;Greece;Poland;Switzerland;Taiwan;Turkey |
| 26 | EUCTR2010-022636-37-AT (EUCTR) | 03/08/2011 | 27/07/2011 | The ATTRACT Study is a phase 3 clinical study that will measure theeffectiveness and safety of a new investigational medication, when compared to Enzyme Replacement Therapy, for the treatment of patients with Fabry disease | A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT - ATTRACT | Fabry disease MedDRA version: 16.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: Not applicable Trade Name: Replagal INN or Proposed INN: AGALSIDASE ALFA Trade Name: Fabrazyme INN or Proposed INN: AGALSIDASE BETA | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 68 | Phase 3 | France;United States;Greece;Brazil;Belgium;Denmark;Australia;Austria;Germany;Japan;Italy;United Kingdom | ||
| 27 | EUCTR2010-022636-37-DK (EUCTR) | 03/05/2011 | 06/04/2011 | The ATTRACT Study is a phase 3 clinical study that will measure theeffectiveness and safety of a new investigational medication, when compared to Enzyme Replacement Therapy, for the treatment of patients with Fabry disease | A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT - ATTRACT | Fabry disease MedDRA version: 16.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: Not applicable Trade Name: Replagal INN or Proposed INN: AGALSIDASE ALFA Trade Name: Fabrazyme INN or Proposed INN: AGALSIDASE BETA | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 68 | Phase 3 | United States;France;Greece;Belgium;Brazil;Austria;Australia;Denmark;Germany;United Kingdom;Japan;Italy | ||
| 28 | EUCTR2010-022636-37-GB (EUCTR) | 15/04/2011 | 22/12/2010 | The ATTRACT Study is a phase 3 clinical study that will measure theeffectiveness and safety of a new investigational medication, when compared to Enzyme Replacement Therapy, for the treatment of patients with Fabry disease | A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT - ATTRACT | Fabry disease MedDRA version: 16.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: Not applicable Trade Name: Replagal INN or Proposed INN: AGALSIDASE ALFA Trade Name: Fabrazyme INN or Proposed INN: AGALSIDASE BETA | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 68 | Phase 3 | United States;France;Greece;Belgium;Brazil;Denmark;Austria;Australia;Germany;Japan;Italy;United Kingdom | ||
| 29 | EUCTR2010-022636-37-BE (EUCTR) | 18/01/2011 | 16/12/2010 | The ATTRACT Study is a phase 3 clinical study that will measure theeffectiveness and safety of a new investigational medication, when compared to Enzyme Replacement Therapy, for the treatment of patients with Fabry disease | A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT - ATTRACT | Fabry disease MedDRA version: 16.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Inactive Reminder Capsules Product Code: Inactive Reminder Capsules INN or Proposed INN: Not applicable Trade Name: Replagal INN or Proposed INN: AGALSIDASE ALFA Trade Name: Fabrazyme INN or Proposed INN: AGALSIDASE BETA | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 68 | Phase 3 | United States;France;Greece;Brazil;Belgium;Denmark;Austria;Australia;Germany;United Kingdom;Japan;Italy | ||
| 30 | EUCTR2009-013459-31-ES (EUCTR) | 30/03/2010 | 22/12/2009 | ESTUDIO DOBLE CIEGO, ALEATORIZADO Y CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA, LA SEGURIDAD Y LA FARMACODINAMIA DE AT1001 EN PACIENTES CON ENFERMEDAD DE FABRY Y MUTACIONES EN GLA SENSIBLES A AT1001.A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS. | ESTUDIO DOBLE CIEGO, ALEATORIZADO Y CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA, LA SEGURIDAD Y LA FARMACODINAMIA DE AT1001 EN PACIENTES CON ENFERMEDAD DE FABRY Y MUTACIONES EN GLA SENSIBLES A AT1001.A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS. | Enfermedad de Fabry.Fabry Disease. MedDRA version: 12.0;Level: LLT;Classification code 10016016;Term: Fabry's disease | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 31 | EUCTR2009-013459-31-DK (EUCTR) | 11/03/2010 | 27/01/2010 | A CLINICAL STUDY THAT WILL MEASURE THE EFFECTIVENESS AND SAFETY OF A NEW INVESTIGATIONAL MEDICATION FOR THE TREATMENT OF PATIENTS WITH FABRY DISEASE | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease | Fabry Disease MedDRA version: 15.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Inactive Reminder Product INN or Proposed INN: Not applicable | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | United States;Spain;Turkey;Italy;United Kingdom;Egypt;France;Canada;Argentina;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Netherlands | |||
| 32 | EUCTR2009-013459-31-BE (EUCTR) | 08/03/2010 | 16/12/2009 | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 in Patients with Fabry Disease | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 in Patients with Fabry Disease | Fabry Disease MedDRA version: 12.0;Level: LLT;Classification code 10016016;Term: Fabry's disease | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Reminder Product INN or Proposed INN: Not applicable | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 33 | EUCTR2009-013459-31-NL (EUCTR) | 03/03/2010 | 20/11/2009 | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 in Patients with Fabry Disease | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 in Patients with Fabry Disease | Fabry Disease MedDRA version: 12.0;Level: LLT;Classification code 10016016;Term: Fabry's disease | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Reminder Product INN or Proposed INN: Not applicable | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Spain;Belgium;Denmark;Germany;Netherlands;Italy;United Kingdom | ||
| 34 | EUCTR2009-013459-31-IT (EUCTR) | 02/02/2010 | 15/01/2010 | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - ND | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - ND | Fabry disease MedDRA version: 9.1;Level: LLT;Classification code 10016016 | INN or Proposed INN: migalastat hydrochloride | AMICUS THERAPEUTICS, INC | NULL | Not Recruiting | Female: yes Male: yes | 60 | France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | |||
| 35 | EUCTR2009-013459-31-GB (EUCTR) | 10/12/2009 | 11/09/2009 | A CLINICAL STUDY THAT WILL MEASURE THE EFFECTIVENESS AND SAFETY OF A NEW INVESTIGATIONAL MEDICATION FOR THE TREAMENT OF PATIENTS WITH FABRY DISEASE | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease | Fabry Disease MedDRA version: 14.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Inactive Reminder Product Product Code: Inactive Reminder Product INN or Proposed INN: Not applicable | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Turkey;Italy;United Kingdom;Egypt;France;Canada;Argentina;Brazil;Belgium;Denmark;Australia;South Africa;Germany;Netherlands | ||
| 36 | EUCTR2009-013459-31-FR (EUCTR) | 13/11/2009 | 01/10/2009 | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 in Patients with Fabry Disease | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 in Patients with Fabry Disease | Fabry Disease MedDRA version: 12.0;Level: LLT;Classification code 10016016;Term: Fabry's disease | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 37 | NCT00925301 (ClinicalTrials.gov) | October 23, 2009 | 19/6/2009 | Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease | A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamics of AT1001 in Patients With Fabry Disease and AT1001-Responsive GLA Mutations | Fabry Disease | Drug: migalastat hydrochloride;Drug: Placebo | Amicus Therapeutics | NULL | Completed | 16 Years | 74 Years | All | 67 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Denmark;Egypt;France;Italy;Poland;Spain;Turkey;United Kingdom;Belgium;Chile;Germany;Israel;Netherlands;South Africa |
| 38 | EUCTR2009-013459-31-DE (EUCTR) | 03/11/2009 | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 in Patients with Fabry Disease | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS - Study of the Effects of Oral AT1001 in Patients with Fabry Disease | Fabry Disease MedDRA version: 12.0;Level: LLT;Classification code 10016016;Term: Fabry's disease | Product Name: migalastat hydrochloride Product Code: AT1001 INN or Proposed INN: migalastat hydrochloride Other descriptive name: 1-deoxygalactonojirimycin hydrochloride Product Name: Reminder Product INN or Proposed INN: Not applicable | Amicus Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | France;Spain;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom | ||||
| 39 | EUCTR2017-000146-21-DE (EUCTR) | 26/03/2019 | AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABLE GLA VARIANTS | AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABLE GLA VARIANTS | Fabry disease and with amenable GLA variants MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Galafold Product Name: Migalastat Product Code: AT1001 INN or Proposed INN: migalastat Other descriptive name: MIGALASTAT HYDROCHLORIDE | Amicus Therapeutics, UK Ltd | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Australia;Germany;United Kingdom;Italy |