List all clinical trials by discovery date. Accepts regular expressions in search.

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{
    "count": 4565,
    "next": "http://api.gregory-ms.com/trials/?page=72",
    "previous": "http://api.gregory-ms.com/trials/?page=70",
    "results": [
        {
            "trial_id": 3382,
            "title": "Early Cognitive Impairment in Multiple Sclerosis",
            "summary": null,
            "published_date": "2010-06-07T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.939663Z",
            "link": "http://clinicaltrials.gov/show/NCT01157728",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT01157728"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "4677811",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Early Cognitive Impairment in Multiple Sclerosis: a Multimodal MRI Study Evaluating the Relative Contribution of Cortical and White Matter Tract Injury",
            "primary_sponsor": "Assistance Publique - Hôpitaux de Paris",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "40 Years",
            "inclusion_gender": "Both",
            "date_enrollement": "2008-05-14",
            "target_size": "69",
            "study_type": "Observational",
            "study_design": "Observational Model: Cohort, Time Perspective: Prospective",
            "phase": "N/A",
            "countries": "France",
            "contact_firstname": "",
            "contact_lastname": "Bruno Stankoff, MD,PhD",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "Hôpital de la Salpétrière",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Relapsing remitting Multiple Sclerosis patients\r<br>\r<br>          -  Age: 18-40 years\r<br>\r<br>          -  Evolving between 3 and 5 years\r<br>\r<br>          -  EDSS<5\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  MRI exclusion criteria (metallic prothetic, pace maker etc)\r<br>\r<br>          -  Renal failure due to Gadolinium injection\r<br>\r<br>          -  Major depressive disorder\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis;Cognitive Impairment",
            "intervention": null,
            "primary_outcome": null,
            "secondary_outcome": null,
            "secondary_id": "P071102",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3381,
            "title": "Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis",
            "summary": null,
            "published_date": "2010-07-07T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.919577Z",
            "link": "http://clinicaltrials.gov/show/NCT01158183",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT01158183"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "4677846",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon ß-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis",
            "primary_sponsor": "Bayer",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "65 Years",
            "inclusion_gender": "Both",
            "date_enrollement": "2007-07-14",
            "target_size": "226",
            "study_type": "Observational",
            "study_design": "Observational Model: Cohort, Time Perspective: Prospective",
            "phase": "N/A",
            "countries": "United States",
            "contact_firstname": "",
            "contact_lastname": "Bayer Study Director",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "Bayer",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Provides written informed consent to participate in the study\r<br>\r<br>          -  At least 18 but no more than 65 years old\r<br>\r<br>          -  Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed\r<br>             clinically isolated syndrome (CIS)\r<br>\r<br>          -  Initiating Betaseron  therapy, or resuming Betaseron after not having used it for at\r<br>             least three months\r<br>\r<br>          -  Willing and able to provide a valid e-mail address which will be in use for the\r<br>             duration of the study\r<br>\r<br>          -  Willing and able to complete study questionnaires via the Internet\r<br>\r<br>          -  Has reliable Internet access for the duration of the study\r<br>\r<br>          -  Completes the baseline patient questionnaire\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0\r<br>\r<br>          -  Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the\r<br>             study participant's ability to provide informed consent or accurately complete the\r<br>             monthly patient questionnaire\r<br>\r<br>          -  Any use of Betaseron within the three months prior to study entry\r<br>\r<br>          -  Inability to read, write, or speak the English language\r<br>\r<br>          -  Illness or disease other than multiple sclerosis that the Investigator believes is\r<br>             likely to cause the patient's death or incapacity within twelve months\r<br>\r<br>          -  Any severe, uncontrolled illness or condition that the Investigator believes could\r<br>             dominate the patient's quality of life\r<br>\r<br>          -  Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that\r<br>             is likely to be exacerbated by treatment with Interferon\r<br>\r<br>          -  Current use of any immunosuppressive medication\r<br>\r<br>          -  Previous participation in a multiple sclerosis (MS) clinical trial within the three\r<br>             months prior to study entry\r<br>\r<br>          -  Previous use of monoclonal antibodies treating MS within the three months prior to\r<br>             study entry\r<br>\r<br>          -  Current use of any secondary treatment for multiple sclerosis other than the episodic\r<br>             use of steroids during relapses or exacerbations\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis, Relapsing-Remitting",
            "intervention": "Drug: BAY86-5046_Interferon-beta-1b",
            "primary_outcome": "Key Objective: To collect patient reported outcomes and clinical assessments via the same web-based data capture tool in a real world setting in relapse-remitting multiple sclerosis patients",
            "secondary_outcome": null,
            "secondary_id": "BF0714US;311644;14838",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3380,
            "title": "A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS",
            "summary": null,
            "published_date": "2010-07-13T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.898209Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018705-11",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2010-018705-11-BE"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "5060132",
            "last_refreshed_on": "2015-08-17",
            "scientific_title": "A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS",
            "primary_sponsor": "Merck Serono S.A. - Geneva",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "EU Clinical Trials Register",
            "recruitment_status": "Not Recruiting",
            "other_records": "Yes",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "<br>Female: yes<br>Male: yes<br>",
            "date_enrollement": "2010-09-13",
            "target_size": "376",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: no\nRandomised: no\nOpen: no\nSingle blind: no\nDouble blind: no\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: no\nOther: no",
            "phase": null,
            "countries": "United States;Czech Republic;Greece;Canada;Spain;Belgium;Ukraine;Russian Federation;Germany;Japan",
            "contact_firstname": "Communication Center Merck KGaA",
            "contact_lastname": null,
            "contact_address": "Frankfurter Strasse 250",
            "contact_email": "[email protected]",
            "contact_tel": null,
            "contact_affiliation": "Merck KGaA",
            "inclusion_criteria": "Inclusion criteria: <br>Patients will be eligible to participate in this study if they meet all of the following criteria:\r<br>\r<br>1. Completed 26 weeks of double-blind phase of Study ONO-4641POU006\r<br>\r<br>2. For females:\r<br>a. Patients of childbearing potential who agree to use an acceptable form of birth control (i.e. double barrier method; diaphragm plus condom, intrauterine device plus condom, hormonal contraception plus condom, spermicidal gel plus condom, or abstinence) throughout the study and until 2 months after the last dose;\r<br>b. Negative serum and urine human chorionic gonadotropin (hCG) assay at Visit 9;\r<br>\r<br>3. For males: \r<br>a. Agree to use a condom with spermicide when engaging in sexual intercourse during participation in the study and until 2 months after the last dose;\r<br>b. Agree to refrain from sperm donation during participation in the study and until 2 months after the last dose;\r<br>\r<br>4. Able and willing to provide signed, written, Informed Consent.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 376<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 0<br>",
            "exclusion_criteria": "Exclusion criteria: <br>Patients will not be eligible to participate in this study if any of the following criteria apply:\r<br>\r<br>1. Presence of any dermatological abnormalities during Study ONO-4641POU006 that in the opinion of the investigator or the Sponsor (Ono Pharmaceutical Co., Ltd.) could increase the risk of the patient developing a skin cancer;\r<br>\r<br>2. In the opinion of the Investigator, a patient who may not be able to cooperate fully with the study staff, may have difficulty in some study requirements, or is otherwise not qualified for the study.<br>",
            "condition": "Relapsing-remitting Multiple Sclerosis <br>MedDRA version: 14.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]",
            "intervention": "<br>Product Name: ONO-4641/MSC2430913A<br>Product Code: ONO-4641/MSC2430913A<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: ONO-4641/MSC2430913A<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.05-<br><br>Product Name: ONO-4641/MSC2430913A<br>Product Code: ONO-4641/MSC2430913A<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: ONO-4641/MSC2430913A<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.1-<br><br>Product Name: ONO-4641/MSC2430913A<br>Product Code: ONO-4641/MSC2430913A<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: ONO-4641/MSC2430913A<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.15-<br><br>",
            "primary_outcome": "Main Objective: The primary objective of this 122-week active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis (RRMS) in patients who have completed an initial 26-week study (ONO-4641POU006).;Secondary Objective: N/A;Primary end point(s): The number of Gd-enhanced lesions, lesion volume, and brain volume obtained by MRI at Weeks 40, 52, 100, and 148 will be compared with that of the baseline of the Extension Study<br><br>;Timepoint(s) of evaluation of this end point: Weeks 0, 40, 52, 100, and 148",
            "secondary_outcome": "Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A",
            "secondary_id": "ONO-4641POU007;NCT01226745",
            "source_support": "Merck Serono S.A. - Geneva",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3379,
            "title": "Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients",
            "summary": null,
            "published_date": "2010-07-20T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.877922Z",
            "link": "https://clinicaltrials.gov/show/NCT01167426",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT01167426"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "6498029",
            "last_refreshed_on": "2017-10-19",
            "scientific_title": "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.",
            "primary_sponsor": "Teva Neuroscience, Inc.",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "N/A",
            "inclusion_gender": "All",
            "date_enrollement": "2010-07-14",
            "target_size": "148",
            "study_type": "Interventional",
            "study_design": null,
            "phase": "Phase 3",
            "countries": "United States;United States;United States;United States",
            "contact_firstname": "; ; ;",
            "contact_lastname": "Tom Smith, MD;Tom Smith, MD;Tom Smith, MD;Tom Smith, MD",
            "contact_address": null,
            "contact_email": ";;;",
            "contact_tel": ";;;",
            "contact_affiliation": "Teva Neuroscience, Inc.;Teva Neuroscience, Inc.;Teva Neuroscience, Inc.;Teva Neuroscience, Inc.",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Patients = 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis\r<br>             (RRMS) or Clinically Isolated Syndrome (CIS)\r<br>\r<br>          -  Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a\r<br>             minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of\r<br>             daily injections\r<br>\r<br>          -  Willing and able to complete all procedures and evaluations related to the study\r<br>\r<br>          -  Willing to continue to follow usual injection site preparation and routine adjunctive\r<br>             local injection site reactions (LISR) management techniques\r<br>\r<br>          -  Willing and able to provide written informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Currently using or treated with another immunomodulating therapy (IMT) in conjunction\r<br>             with GA in the 30 days prior to screening for this study\r<br>\r<br>          -  Currently using an investigational drug or using treatment with any other\r<br>             investigational agent in the 30 days prior to screening for this study\r<br>\r<br>          -  Pregnant or planning pregnancy or breastfeeding\r<br>\r<br>          -  Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.)\r<br>             either currently or in the past 30 days prior to screening for this study\r<br>\r<br>          -  Any other medical or psychiatric conditions that would make the patient unsuitable for\r<br>             this research, as determined by the Investigator\r<br>\r<br>          -  Unwilling to perform all daily injections with an autoject 2 device\r<br>\r<br>          -  Previous participation in any study evaluating the new 20 mg/0.5 mL formulation\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Patients = 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis\r<br>             (RRMS) or Clinically Isolated Syndrome (CIS)\r<br>\r<br>          -  Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a\r<br>             minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of\r<br>             daily injections\r<br>\r<br>          -  Willing and able to complete all procedures and evaluations related to the study\r<br>\r<br>          -  Willing to continue to follow usual injection site preparation and routine adjunctive\r<br>             local injection site reactions (LISR) management techniques\r<br>\r<br>          -  Willing and able to provide written informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Currently using or treated with another immunomodulating therapy (IMT) in conjunction\r<br>             with GA in the 30 days prior to screening for this study\r<br>\r<br>          -  Currently using an investigational drug or using treatment with any other\r<br>             investigational agent in the 30 days prior to screening for this study\r<br>\r<br>          -  Pregnant or planning pregnancy or breastfeeding\r<br>\r<br>          -  Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.)\r<br>             either currently or in the past 30 days prior to screening for this study\r<br>\r<br>          -  Any other medical or psychiatric conditions that would make the patient unsuitable for\r<br>             this research, as determined by the Investigator\r<br>\r<br>          -  Unwilling to perform all daily injections with an autoject 2 device\r<br>\r<br>          -  Previous participation in any study evaluating the new 20 mg/0.5 mL formulation\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Patients = 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis\r<br>             (RRMS) or Clinically Isolated Syndrome (CIS)\r<br>\r<br>          -  Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a\r<br>             minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of\r<br>             daily injections\r<br>\r<br>          -  Willing and able to complete all procedures and evaluations related to the study\r<br>\r<br>          -  Willing to continue to follow usual injection site preparation and routine adjunctive\r<br>             local injection site reactions (LISR) management techniques\r<br>\r<br>          -  Willing and able to provide written informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Currently using or treated with another immunomodulating therapy (IMT) in conjunction\r<br>             with GA in the 30 days prior to screening for this study\r<br>\r<br>          -  Currently using an investigational drug or using treatment with any other\r<br>             investigational agent in the 30 days prior to screening for this study\r<br>\r<br>          -  Pregnant or planning pregnancy or breastfeeding\r<br>\r<br>          -  Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.)\r<br>             either currently or in the past 30 days prior to screening for this study\r<br>\r<br>          -  Any other medical or psychiatric conditions that would make the patient unsuitable for\r<br>             this research, as determined by the Investigator\r<br>\r<br>          -  Unwilling to perform all daily injections with an autoject 2 device\r<br>\r<br>          -  Previous participation in any study evaluating the new 20 mg/0.5 mL formulation\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Patients = 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis\r<br>             (RRMS) or Clinically Isolated Syndrome (CIS)\r<br>\r<br>          -  Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a\r<br>             minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of\r<br>             daily injections\r<br>\r<br>          -  Willing and able to complete all procedures and evaluations related to the study\r<br>\r<br>          -  Willing to continue to follow usual injection site preparation and routine adjunctive\r<br>             local injection site reactions (LISR) management techniques\r<br>\r<br>          -  Willing and able to provide written informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Currently using or treated with another immunomodulating therapy (IMT) in conjunction\r<br>             with GA in the 30 days prior to screening for this study\r<br>\r<br>          -  Currently using an investigational drug or using treatment with any other\r<br>             investigational agent in the 30 days prior to screening for this study\r<br>\r<br>          -  Pregnant or planning pregnancy or breastfeeding\r<br>\r<br>          -  Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.)\r<br>             either currently or in the past 30 days prior to screening for this study\r<br>\r<br>          -  Any other medical or psychiatric conditions that would make the patient unsuitable for\r<br>             this research, as determined by the Investigator\r<br>\r<br>          -  Unwilling to perform all daily injections with an autoject 2 device\r<br>\r<br>          -  Previous participation in any study evaluating the new 20 mg/0.5 mL formulation\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis",
            "intervention": "Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL;Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL;Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL;Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL",
            "primary_outcome": "Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience;Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience",
            "secondary_outcome": "Patient Injection Experience Preference",
            "secondary_id": "PM034",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3378,
            "title": "Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)",
            "summary": null,
            "published_date": "2010-05-08T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.846712Z",
            "link": "http://clinicaltrials.gov/show/NCT01181115",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT01181115"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "4679600",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple Sclerosis",
            "primary_sponsor": "Biogen Idec",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "55 Years",
            "inclusion_gender": "Both",
            "date_enrollement": "2010-04-14",
            "target_size": "60",
            "study_type": "Interventional",
            "study_design": "Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment",
            "phase": "Phase 3",
            "countries": "China",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Ability to understand risks of study and provide informed consent.\r<br>\r<br>          -  Must be Chinese, aged 18 to 55 years inclusive at time of consent.\r<br>\r<br>          -  Must have diagnosis of relapsing MS of 3 months duration at time of screening visit.\r<br>\r<br>          -  Must have at least 1 documented MS attack within 3 years of Day 1.\r<br>\r<br>          -  Must have EDSS score of 0 to 5 inclusive at screening visit.\r<br>\r<br>          -  All male subjects & female subjects of child-bearing potential must practice\r<br>             effective contraception during the study.\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Have a diagnosis of primary progressive, secondary progressive, or progressive\r<br>             relapsing MS.\r<br>\r<br>          -  Have had a clinical MS attack within the 50 days prior to Day 1, and or the subject\r<br>             has not stabilized from a previous attack in the opinion of the Investigator.\r<br>\r<br>          -  The subject is unable to undergo a brain MRI scan for any reason.\r<br>\r<br>          -  The subject's screening and Day 1 MRIs are both normal (negative) for lesions\r<br>             consistent with MS (Gd-enhancing lesions are not required, but one of the 2 MRIs\r<br>             should be consistent with MS).\r<br>\r<br>          -  History of severe allergic or anaphylactic reactions.\r<br>\r<br>          -  Known allergy to any component of the Avonex Formulation.\r<br>\r<br>          -  History of any clinically significant cardiac, endocrinologic, hematologic, hepatic,\r<br>             immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric,\r<br>             renal or other major disease.\r<br>\r<br>          -  Subjects with a history of malignant disease, including solid tumors, and hematologic\r<br>             malignancies (except basal cell and squamous cell carcinomas of the skin that have\r<br>             been completely excised and considered cured).\r<br>\r<br>          -  History of seizure disorder or unexplained blackouts OR history of a seizure within 6\r<br>             months prior to Day 1.\r<br>\r<br>          -  History of suicidal ideation or an episode of clinically severe depression (as\r<br>             determined by the Investigator) within 6 months prior to Day 1.  Note:  subjects\r<br>             receiving ongoing antidepressant therapy will not be excluded from the study unless\r<br>             the medication has been increased within the 6 months prior to Day 1.\r<br>\r<br>          -  Clinically significant abnormal ECG values as determined by the Investigator.\r<br>\r<br>          -  Known history of human immunodeficiency virus (HIV).\r<br>\r<br>          -  Known history of, or positive test result for hepatitis C virus (test for hepatitis C\r<br>             virus antibody HCV Ab) or hepatitis B virus (test for Hepatitis B surface Antigen\r<br>             HBsAg) and/or Hepatitis B Core Antibody (HBcAb).\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis",
            "intervention": "Drug: Avonex",
            "primary_outcome": "The number and proportion of subjects with adverse events (AEs);Assessment of clinical laboratory parameters;Assessment of vital signs and physical examinations;Assessment of electrocardiogram (ECG);Assessment of immunogenicity;Incidence of depression;Incidence of flu-like symptoms;Subject assessment of injection site pain;Clinical assessment of the injection site",
            "secondary_outcome": "Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time;Number of Gd-enhancing lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment;Number of new or newly enlarging T2-weighted lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment;Volume of T2-weighted lesions on brain MRI scans taken after 6 months following initiation of Avonex treatment;Assess pharmacodynamic response to Avonex by evaluating the change from baseline in serum levels of neopterin",
            "secondary_id": "108MS301",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3377,
            "title": "Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)",
            "summary": null,
            "published_date": "2010-05-08T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.828144Z",
            "link": "http://clinicaltrials.gov/show/NCT01181089",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT01181089"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "4679598",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF) and Safety in Subjects With Secondary Progressive Multiple Sclerosis",
            "primary_sponsor": "Biogen Idec",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "57 Years",
            "inclusion_gender": "Both",
            "date_enrollement": "2010-09-14",
            "target_size": "0",
            "study_type": "Interventional",
            "study_design": "Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment",
            "phase": "Phase 1/Phase 2",
            "countries": "Canada;United Kingdom",
            "contact_firstname": null,
            "contact_lastname": null,
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": null,
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  A diagnosis of Secondary Progressive Multiple Sclerosis\r<br>\r<br>          -  Aged 18 to 57 years old, at the time of informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  History of clinically important (as determined by the investigator) cardiac,\r<br>             endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or\r<br>             hematologic insufficiency or any other major disease other than MS ( Multiple\r<br>             Sclerosis)\r<br>\r<br>          -  Inability in the opinion of the Investigator to comply with study requirements\r<br>\r<br>          -  Other protocol-defined criteria may apply\r<br>",
            "exclusion_criteria": null,
            "condition": "Secondary Progressive Multiple Sclerosis",
            "intervention": "Biological: Placebo;Biological: Baminercept",
            "primary_outcome": "Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo",
            "secondary_outcome": "Number of subjects experiencing Serious Adverse Event (SAE) and  Adverse Event (AE) with baminercept relative to placebo",
            "secondary_id": "104MS101",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3376,
            "title": "Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis",
            "summary": null,
            "published_date": "2010-08-18T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.808327Z",
            "link": "http://clinicaltrials.gov/show/NCT01184833",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT01184833"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "4679885",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis",
            "primary_sponsor": "Bayer",
            "retrospective_flag": "No",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "18 Years",
            "inclusion_agemax": "N/A",
            "inclusion_gender": "Both",
            "date_enrollement": "2008-09-14",
            "target_size": "852",
            "study_type": "Observational",
            "study_design": "Observational Model: Cohort, Time Perspective: Prospective",
            "phase": "N/A",
            "countries": "Poland",
            "contact_firstname": "",
            "contact_lastname": "Bayer Study Director",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "Bayer",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Relapsing-remitting multiple sclerosis\r<br>\r<br>          -  Age >/= 18 years\r<br>\r<br>          -  Start of treatment with Betaferon not earlier than 60 days prior to inclusion\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Synonymous with contraindications to Betaferon\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis",
            "intervention": "Drug: Interferon beta-1b (Betaseron, BAY86-5046)",
            "primary_outcome": "Rate of discontinuation of Betaferon",
            "secondary_outcome": "Number of missed doses of Betaferon;Depression score as measured by CES-D questionnaire;Neurological disability score as measured by EDSS scale;Overall tolerability of treatment as measured by rate of adverse events",
            "secondary_id": "BF0813PL;14323",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3375,
            "title": "JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)",
            "summary": null,
            "published_date": "2010-08-19T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.788545Z",
            "link": "http://clinicaltrials.gov/show/NCT01185717",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT01185717"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "4679952",
            "last_refreshed_on": "2015-02-19",
            "scientific_title": "Epidemiology of Anti-JCV Antibody Prevalence in Multiple Sclerosis Patients",
            "primary_sponsor": "Biogen Idec",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "N/A",
            "inclusion_agemax": "N/A",
            "inclusion_gender": "Both",
            "date_enrollement": "2010-09-14",
            "target_size": "7726",
            "study_type": "Observational",
            "study_design": "Time Perspective: Cross-Sectional",
            "phase": "N/A",
            "countries": "Australia;Austria;Belgium;Canada;Germany;Ireland;Netherlands;Portugal;Switzerland;United Kingdom;Czech Republic",
            "contact_firstname": "",
            "contact_lastname": "Medical Director",
            "contact_address": null,
            "contact_email": null,
            "contact_tel": null,
            "contact_affiliation": "Biogen Idec",
            "inclusion_criteria": "<br>        Key Inclusion Criteria:\r<br>\r<br>          -  All candidates for this study must have the ability to understand the purpose of the\r<br>             study and provide signed and dated informed consent.\r<br>\r<br>          -  All patients with a diagnosis of Multiple Sclerosis (MS) of any type, irrespective of\r<br>             their treatment, are eligible to participate once.\r<br>\r<br>        Key Exclusion Criteria:\r<br>\r<br>          -  None\r<br>\r<br>        NOTE:  Other protocol defined Inclusion/Exclusion criteria may apply.\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis",
            "intervention": null,
            "primary_outcome": "Prevalence of anti-JCV antibodies",
            "secondary_outcome": null,
            "secondary_id": "100JC401",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3374,
            "title": "Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)",
            "summary": null,
            "published_date": "2010-08-25T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.765780Z",
            "link": "https://clinicaltrials.gov/show/NCT01188811",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "nct": "NCT01188811"
            },
            "categories": [
                {
                    "category_id": 43,
                    "category_description": "Lipoic Acid",
                    "category_name": "Lipoic Acid",
                    "category_slug": "lipoic-acid",
                    "category_terms": [
                        "Lipoic acid"
                    ],
                    "article_count": 7
                }
            ],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "6498338",
            "last_refreshed_on": "2017-10-19",
            "scientific_title": "Lipoic Acid for Neuroprotection in Secondary Progressive MS",
            "primary_sponsor": "VA Office of Research and Development",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "ClinicalTrials.gov",
            "recruitment_status": "Not recruiting",
            "other_records": "No",
            "inclusion_agemin": "40 Years",
            "inclusion_agemax": "70 Years",
            "inclusion_gender": "All",
            "date_enrollement": "2010-10-14",
            "target_size": "54",
            "study_type": "Interventional",
            "study_design": null,
            "phase": "Phase 2/Phase 3",
            "countries": "United States;United States;United States;United States",
            "contact_firstname": "; ; ;",
            "contact_lastname": "Rebecca Spain, MD MSPH;Rebecca Spain, MD MSPH;Rebecca Spain, MD MSPH;Rebecca Spain, MD MSPH",
            "contact_address": null,
            "contact_email": ";;;",
            "contact_tel": ";;;",
            "contact_affiliation": "VA Portland Health Care System, Portland, OR;VA Portland Health Care System, Portland, OR;VA Portland Health Care System, Portland, OR;VA Portland Health Care System, Portland, OR",
            "inclusion_criteria": "<br>        Inclusion Criteria:\r<br>\r<br>          -  Diagnosis of SPMS\r<br>\r<br>          -  Age 40-70 years\r<br>\r<br>          -  Able to understand English and able to give informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Unable to undergo MRI testing\r<br>\r<br>          -  For ambulatory subjects only, a self-reported medical or neurological condition other\r<br>             than MS that is a cause of progressive or fluctuating problems that affect\r<br>             walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis,\r<br>             uncontrolled heart or lung disease)\r<br>\r<br>          -  For ambulatory subjects only, fixed and/or stable conditions of less than 1 years\r<br>             duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism,\r<br>             stroke, etc.)\r<br>\r<br>          -  Pregnant or breast-feeding.\r<br>\r<br>          -  Current major disease or disorder other than MS (such as cancer, kidney, heart or lung\r<br>             disease, post-traumatic stress disorder) that may interfere with study procedures\r<br>\r<br>          -  Natalizumab, mitoxantrone, azathioprine taken in the last 12 months\r<br>\r<br>          -  Other immunosuppressants or chemotherapies taken in the last 12 months\r<br>\r<br>          -  Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months\r<br>\r<br>          -  IV or oral steroids taken in the past 60 days.\r<br>\r<br>          -  Lipoic acid taken in the past 60 days.\r<br>\r<br>          -  Subject has insulin-dependent diabetes or is not controlled on oral diabetes\r<br>             medications\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Diagnosis of SPMS\r<br>\r<br>          -  Age 40-70 years\r<br>\r<br>          -  Able to understand English and able to give informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Unable to undergo MRI testing\r<br>\r<br>          -  For ambulatory subjects only, a self-reported medical or neurological condition other\r<br>             than MS that is a cause of progressive or fluctuating problems that affect\r<br>             walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis,\r<br>             uncontrolled heart or lung disease)\r<br>\r<br>          -  For ambulatory subjects only, fixed and/or stable conditions of less than 1 years\r<br>             duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism,\r<br>             stroke, etc.)\r<br>\r<br>          -  Pregnant or breast-feeding.\r<br>\r<br>          -  Current major disease or disorder other than MS (such as cancer, kidney, heart or lung\r<br>             disease, post-traumatic stress disorder) that may interfere with study procedures\r<br>\r<br>          -  Natalizumab, mitoxantrone, azathioprine taken in the last 12 months\r<br>\r<br>          -  Other immunosuppressants or chemotherapies taken in the last 12 months\r<br>\r<br>          -  Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months\r<br>\r<br>          -  IV or oral steroids taken in the past 60 days.\r<br>\r<br>          -  Lipoic acid taken in the past 60 days.\r<br>\r<br>          -  Subject has insulin-dependent diabetes or is not controlled on oral diabetes\r<br>             medications\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Diagnosis of SPMS\r<br>\r<br>          -  Age 40-70 years\r<br>\r<br>          -  Able to understand English and able to give informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Unable to undergo MRI testing\r<br>\r<br>          -  For ambulatory subjects only, a self-reported medical or neurological condition other\r<br>             than MS that is a cause of progressive or fluctuating problems that affect\r<br>             walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis,\r<br>             uncontrolled heart or lung disease)\r<br>\r<br>          -  For ambulatory subjects only, fixed and/or stable conditions of less than 1 years\r<br>             duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism,\r<br>             stroke, etc.)\r<br>\r<br>          -  Pregnant or breast-feeding.\r<br>\r<br>          -  Current major disease or disorder other than MS (such as cancer, kidney, heart or lung\r<br>             disease, post-traumatic stress disorder) that may interfere with study procedures\r<br>\r<br>          -  Natalizumab, mitoxantrone, azathioprine taken in the last 12 months\r<br>\r<br>          -  Other immunosuppressants or chemotherapies taken in the last 12 months\r<br>\r<br>          -  Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months\r<br>\r<br>          -  IV or oral steroids taken in the past 60 days.\r<br>\r<br>          -  Lipoic acid taken in the past 60 days.\r<br>\r<br>          -  Subject has insulin-dependent diabetes or is not controlled on oral diabetes\r<br>             medications\r<br>      ;\r<br>        Inclusion Criteria:\r<br>\r<br>          -  Diagnosis of SPMS\r<br>\r<br>          -  Age 40-70 years\r<br>\r<br>          -  Able to understand English and able to give informed consent\r<br>\r<br>        Exclusion Criteria:\r<br>\r<br>          -  Unable to undergo MRI testing\r<br>\r<br>          -  For ambulatory subjects only, a self-reported medical or neurological condition other\r<br>             than MS that is a cause of progressive or fluctuating problems that affect\r<br>             walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis,\r<br>             uncontrolled heart or lung disease)\r<br>\r<br>          -  For ambulatory subjects only, fixed and/or stable conditions of less than 1 years\r<br>             duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism,\r<br>             stroke, etc.)\r<br>\r<br>          -  Pregnant or breast-feeding.\r<br>\r<br>          -  Current major disease or disorder other than MS (such as cancer, kidney, heart or lung\r<br>             disease, post-traumatic stress disorder) that may interfere with study procedures\r<br>\r<br>          -  Natalizumab, mitoxantrone, azathioprine taken in the last 12 months\r<br>\r<br>          -  Other immunosuppressants or chemotherapies taken in the last 12 months\r<br>\r<br>          -  Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months\r<br>\r<br>          -  IV or oral steroids taken in the past 60 days.\r<br>\r<br>          -  Lipoic acid taken in the past 60 days.\r<br>\r<br>          -  Subject has insulin-dependent diabetes or is not controlled on oral diabetes\r<br>             medications\r<br>",
            "exclusion_criteria": null,
            "condition": "Multiple Sclerosis, Chronic Progressive;Multiple Sclerosis, Chronic Progressive;Multiple Sclerosis, Chronic Progressive;Multiple Sclerosis, Chronic Progressive",
            "intervention": "Drug: lipoic acid;Drug: Placebo;Drug: lipoic acid;Drug: Placebo;Drug: lipoic acid;Drug: Placebo;Drug: lipoic acid;Drug: Placebo",
            "primary_outcome": "Brain Atrophy by MRI;Brain Atrophy by MRI",
            "secondary_outcome": "Disability Measures: Mobility;Safety Measure: Adverse Events",
            "secondary_id": "B7493-W",
            "source_support": "Please refer to primary and secondary sponsors",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        },
        {
            "trial_id": 3373,
            "title": "Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients\r\nwith Relapsing-Remitting MS receiving Rebif® treatment.",
            "summary": null,
            "published_date": "2010-08-27T00:00:00Z",
            "discovery_date": "2023-12-06T18:18:15.742059Z",
            "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020328-23",
            "source": "WHO XML import",
            "relevant": null,
            "identifiers": {
                "euctr": "EUCTR2010-020328-23-FI"
            },
            "categories": [],
            "export_date": "2024-02-14T00:00:00Z",
            "internal_number": "5043224",
            "last_refreshed_on": "2015-08-04",
            "scientific_title": "A three-arm, randomized, double-blind, placebo controlled, multicenter,\r\nphase II study to evaluate the efficacy of Vigantol® oil as add-on\r\ntherapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving\r\ntreatment with 44 µg tiw of Rebif®\r\n\r\nSOLAR\r\n\r\nSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients\r\nwith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR",
            "primary_sponsor": "Merck Serono",
            "retrospective_flag": "Yes",
            "date_registration": null,
            "source_register": "EU Clinical Trials Register",
            "recruitment_status": "Not Recruiting",
            "other_records": "Yes",
            "inclusion_agemin": null,
            "inclusion_agemax": null,
            "inclusion_gender": "<br>Female: yes<br>Male: yes<br>",
            "date_enrollement": "2010-10-21",
            "target_size": "230",
            "study_type": "Interventional clinical trial of medicinal product",
            "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no\nNumber of treatment arms in the trial: 3",
            "phase": null,
            "countries": "Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands",
            "contact_firstname": "Communication Center Merck KGaA",
            "contact_lastname": null,
            "contact_address": "Frankfurterstr. 250",
            "contact_email": "[email protected]",
            "contact_tel": "+496151725200",
            "contact_affiliation": "Merck Serono",
            "inclusion_criteria": "Inclusion criteria: <br>•Diagnosis of a relapsing-remitting form of MS<br>•Brain and/or spinal MRI with findings typical of MS<br>•A first clinical event prior to Screening.<br>•Disease activity<br>•EDSS score of less than, or equal to 4.0 at Screening.<br>•Currently treated with interferon-beta-1a 44µg (tiw) sc<br>•Willingness and ability to comply with the protocol<br>•Written informed consent<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 230<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>",
            "exclusion_criteria": "Exclusion criteria: <br>•Pregnancy and lactation period<br>•Any disease other than MS that could better explain signs and<br>symptoms.<br>•Complete transverse myelitis or bilateral optic neuritis.<br>•Currently receiving or use at any time of monoclonal antibodies,<br>mitoxantrone, cytotoxic or immunosuppressive therapy (excluding<br>systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.<br>•Use of any cytokine (other than interferon) or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure<br>•Use of oral or systemic corticosteroids or ACTH<br>•Have experienced a relapse within 30 days before the SD1 visit<br>•Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary<br>hyperparathyroidism or granulomatous disorders.<br>•Have an urine calcium/creatinine (mmol/mmol) ratio greater than 1.0 or hypercalcaemia<br>•Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.<br>•Are taking more than 1000 IU (25 µg) of Vitamin D supplement daily.<br>•Have conditions with increased susceptibility to hypercalcaemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.<br>•Have inadequate liver function<br>•Moderate to severe renal impairment<br>•Inadequate bone marrow reserve<br>•History or presence of serious or acute heart disease such as<br>uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).<br>•History or presence of severe depression, history of suicide attempt, or current suicidal ideation.<br>•Epilepsy or seizures not adequately controlled by treatment.<br>•Current or past alcohol or drug abuse.<br>•Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.<br>•Known contra-indication to treatment with vitamin D<br>•Known hypersensitivity to interferon or its excipient(s)<br>•Known hypersensitivity to gadolinium.<br>•Any other condition that would prevent the subject from undergoing an MRI scan.<br>•Signs and symptoms suggestive of transmissible spongiform<br>encephalopathy, or family members who suffer(ed) from such.<br>•Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody)<br>serology (test performed at screening).<br>•Legal incapacity or limited legal capacity.<br>•Another current autoimmune disease, except diabetes.<br>",
            "condition": "Relapsing-Remitting Multiple Sclerosis <br>MedDRA version: 14.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]",
            "intervention": "<br>Trade Name: Vigantol Oel<br>Product Name: Vigantol Oil<br>Product Code: 200106 or EMD 28162<br>Pharmaceutical Form: Oral solution<br>INN or Proposed INN: COLECALCIFEROL<br>CAS Number: 67-97-0<br>Current Sponsor code: 200109, EMD 28162, 300910<br>Other descriptive name: Cholecalciferol, Vitamin D3<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 500-<br>Pharmaceutical form of the placebo: Oral solution<br>Route of administration of the placebo: Oral use<br><br>",
            "primary_outcome": "Secondary Objective: • To assess changes on clinical parameters.<br>• To assess changes in MRI parameters.<br>• To investigate the safety profile up to the end of the Treatment Period (Week48),<br>• To explore pharmacogenetics (PGx), gene expression and circulating biomarkers and to evaluate whether there is a possible relationship to Vigantol® oil treatment outcomes.;Primary end point(s): •\tThe proportion of subjects with DAF status at Week 48.<br>DAF status is defined as a condition described by the absence of all of the following conditions:<br>—\tOccurrence of relapse<br>—\tEDSS progression<br>—\tNew MRI lesions:<br>   \t•  Gd-enhancing<br>        •  T2 lesions<br>;Timepoint(s) of evaluation of this end point: Proportion of Disease Activity Free subjects at week 48;Main Objective: To assess the efficacy of Vigantol® oil versus placebo as add-on therapy<br>in subjects with Relapsing-Remitting Multiple Sclerosis receiving<br>treatment with Rebif®.",
            "secondary_outcome": "Secondary end point(s): •Proportion of relapse-free subjects at week 48<br>•Proportion of subjects free from any EDSS progression at week 48 <br>•Time to confirmed EDSS progression<br>•Proportion of subjects free from confirmed EDSS progression at week 48 <br>•Mean number of new T1 gadolinium-enhancing lesions per subject per scan at week 48 <br>•Cumulative number of T1 gadolinium enhancing lesions at Week 48<br>•Cumulative number of new CUA lesions at week 48<br>•Mean number of CUA lesions per subject per scan at week 48<br>•Mean change from baseline in the total volume of T2 lesions at week 48 (T2 Burden of disease) [mm³]<br>•Proportion of subjects free from new T1-hypointense lesions (black holes) at week 48<br>•Change in cognitive function at weeks 24 and 48 with respect to baseline as measured by Symbol Digit Modalities Test<br>•Proportion of T1 gadolinium-enhancing lesions at Study Day 1 (SD1)<br>that transform into black holes at week 48<br>•Percent Brain Volume Change (PBVC) at week 48 with respect to baseline, and at week 96 with respect to week 48<br>•Change from baseline in MSFC composite score at Weeks 12, 24, 36, 48<br>•Time to first documented relapse<br>•Annualized relapse rate at Weeks 48<br>•Total number of reported relapses at all time points<br>•Proportion of subjects treated with glucocorticoids due to relapses (during 48 weeks)<br>•Proportion of subjects free from T1 gadolinium enhancing lesions at Week 48 <br>•Percentage of new T1-hypointense lesions (black holes) at Weeks 48 within the subgroup of new or enlarging non-enhancing T2<br>lesions<br>•Mean change from baseline in total volume of T1 hypointense lesions at Week 48 (in mm³);Timepoint(s) of evaluation of this end point: As described in Section E.5.2",
            "secondary_id": "EMR200136-532;NCT01285401",
            "source_support": "Merck Serono",
            "ethics_review_status": null,
            "ethics_review_approval_date": null,
            "ethics_review_contact_name": null,
            "ethics_review_contact_address": null,
            "ethics_review_contact_phone": null,
            "ethics_review_contact_email": null,
            "results_date_completed": null,
            "results_url_link": null
        }
    ]
}