Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=4
{ "count": 4830, "next": "http://api.gregory-ms.com/trials/?format=api&page=5", "previous": "http://api.gregory-ms.com/trials/?format=api&page=3", "results": [ { "trial_id": 4318, "title": "Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease", "summary": "<b>Conditions</b>: Motor Neuron Disease, Amyotrophic Lateral Sclerosis; Motor Neuron Disease Progressive Spinal Muscle Atrophy; Primary Lateral Sclerosis; Multiple Sclerosis; Postpoliomyelitis Syndrome\n<br /><b>Interventions</b>: Procedure: 232 Electrode Electrophysiology (EEG-ECG-EMG-EXG)\n<br /><b>Sponsors</b>: University of Dublin, Trinity College; Motor Neurone Disease Association, UK; Irish Research Council, IE; Health Research Board, IE; Research Motor Neurone, IE; Thierry Latran Foundation, FR; ALS Association, USA\n<br /><b>Recruiting</b>", "published_date": "2022-12-19T00:00:00Z", "discovery_date": "2024-03-28T14:55:30.212160Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06320444", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06320444", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13819635", "last_refreshed_on": "2024-03-25", "scientific_title": "Developing Novel Non-invasive Electrophysiological Biomarkers of Dysfunction in Spinal and Cortical Pathways and Sensorimotor Impairments in Motor Neurone Disease", "primary_sponsor": "University of Dublin, Trinity College", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2023-06-15", "target_size": "240", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Ireland", "contact_firstname": "; ;", "contact_lastname": "Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN;Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN;Orla Hardiman,, BSc MB BCh BAO MD FRCPI FAAN", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";+353 1 896 4497;+353 1 896 4497", "contact_affiliation": "Academic Unit of Neurology, Trinity College Dublin, The University of Dublin;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> -\r<br>\r<br> Healthy Volunteers:\r<br>\r<br> - age and gender matched to patient groups\r<br>\r<br> - intact physical ability to take part in the experiment.\r<br>\r<br> Patients:\r<br>\r<br> - Diagnosis of ALS, PLS, PMA, SMA, Polio or MS\r<br>\r<br> - capable of providing informed consent.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> -\r<br>\r<br> Healthy Controls:\r<br>\r<br> - History of neuromuscular\r<br>\r<br> - neurological or active psychiatric disease disease\r<br>\r<br> - history of reaction or allergy to recording environments, equipment and the recording\r<br> gels.\r<br>\r<br> Patients:\r<br>\r<br> - presence of active psychiatric disease\r<br>\r<br> - any medical condition associated with severe neuropathy (e.g. poorly controlled\r<br> diabetes).\r<br>\r<br> - History of reaction or allergy to recording environments, equipment and the recording\r<br> gels.\r<br>", "exclusion_criteria": null, "condition": "Motor Neuron Disease, Amyotrophic Lateral Sclerosis;Motor Neuron Disease Progressive Spinal Muscle Atrophy;Primary Lateral Sclerosis;Multiple Sclerosis;Postpoliomyelitis Syndrome", "intervention": "Procedure: 232 Electrode Electrophysiology (EEG-ECG-EMG-EXG)", "primary_outcome": "Biomarker of sensorimotor integration;Determination of the feasibility of sensorimotor signatures as reliable biomarkers of ALS;Non-invasive recording of the SC functional neuro-electric activity", "secondary_outcome": null, "secondary_id": "CRFSJ0297", "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": 4317, "title": "the EXPOSITION Study", "summary": "<b>Conditions</b>: Multiple Sclerosis, Relapsing-Remitting; Environmental Exposure; Lifestyle Factors\n<br /><b>Sponsors</b>: University of Pavia; National Research Council (Consiglio Nazionale delle Ricerche); IRCCS National Neurological Institute \"C. Mondino\" Foundation\n<br /><b>Not yet recruiting</b>", "published_date": "2024-09-02T00:00:00Z", "discovery_date": "2024-03-28T14:55:25.137506Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06325358", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06325358", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13820013", "last_refreshed_on": "2024-03-25", "scientific_title": "EXPOSITION (EXPosome, Oxidative Stress and InflammaTION) in Persons With Multiple Sclerosis Study", "primary_sponsor": "University of Pavia", "retrospective_flag": "Yes", "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": "2024-04-15", "target_size": "200", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Italy", "contact_firstname": "; ;", "contact_lastname": "Eleonora Tavazzi;Eleonora Tavazzi;Eleonora Tavazzi", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";0382380403;0382 380403", "contact_affiliation": "Neurological Institute-Foundation IRCCS Casimiro Mondino, Pavia, Italy;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - We will include persons with Multiple Sclerosis (pwMS) attending the Centro Sclerosi\r<br> Multipla of the IRCCS Fondazione C. Mondino of Pavia, according to the following\r<br> inclusion criteria:\r<br>\r<br> - Age = 18 years\r<br>\r<br> - Diagnosis of MS according to 2017 McDonald criteria\r<br>\r<br> - Relapsing-remitting course (RR)\r<br>\r<br> - Routine clinical examinations scheduled in the study period September 15, 2023,\r<br> to March 15, 2024,\r<br>\r<br> - Residing in the provinces of Pavia and Milano\r<br>\r<br> - Informed consent form signed\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Exclusion criteria will involve people refusing to participate in the study or people\r<br> not completely meet the inclusion criteria. Potentially eligible pwMS will be screened\r<br> by a neurologist expert in MS who will verify that all the inclusion criteria will be\r<br> fulfilled.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing-Remitting;Environmental Exposure;Lifestyle Factors", "intervention": null, "primary_outcome": "microRNAs;Air quality;Nutritional assessment;Neurofilament (NfL);Cytokines;the Body Mass Index (BMI);Physical activity;Quality of life related to MS;Sleep Quality;Smoking habits;Dietary supplements use;Adherence to Mediterranean diet;Effect of diet on inflammation;waist and height ratio (WHtR);Bioelectrical impedance", "secondary_outcome": "Microbiome and biological biomarkers of oxidative stress and inflammation", "secondary_id": "0040083/23", "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": 4316, "title": "Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Other: Stoller's Afferent Nerve Stimulation (SANS)\n<br /><b>Sponsors</b>: Istituto Auxologico Italiano\n<br /><b>Recruiting</b>", "published_date": "2024-04-03T00:00:00Z", "discovery_date": "2024-03-28T14:55:24.814394Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06314412", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06314412", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13819172", "last_refreshed_on": "2024-03-25", "scientific_title": "Perineal Rehabilitation: Efficacy of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence", "primary_sponsor": "Istituto Auxologico Italiano", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2023-02-13", "target_size": "20", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "N/A", "countries": "Italy", "contact_firstname": "; ;", "contact_lastname": "Laura Perucca, MD;Laura Perucca, MD;Laura Perucca, MD", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";+39 02-619116151;+3902619116247", "contact_affiliation": "Istituto Auxologico Italiano;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - MS diagnosis according to the revised McDonalds criteria. Relapsing-remitting, primary\r<br> and secondary progressive MS forms are allowed;\r<br>\r<br> - Expanded Disability Status Scale (EDSS) between 2 and 6.5 included;\r<br>\r<br> - MiniMental State Examination = cut off 24/84 by sex/age\r<br>\r<br> Exclusion criteria:\r<br>\r<br> - Any of the following in the month before enrolment: an MS relapse; current\r<br> corticosteroids therapy because of MS; change in medicines prescribed against fatigue;\r<br> attending an intensive physical therapy program;\r<br>\r<br> - New or active lesions on a brain or spinal cord MRI scan in the 12 months before the\r<br> study enrolment;\r<br>\r<br> - Any musculoskeletal disease or any additional neurological disorder\r<br>\r<br> - Urinary infections or surgery in perineal regions\r<br>\r<br> - Skin lesions or carcinoma in situ\r<br>\r<br> - Pregnancy\r<br>\r<br> - Expanded Disability Status Scale (EDSS) = 7;\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Stoller's Afferent Nerve Stimulation (SANS)", "primary_outcome": "Measure of variation of incontinence.;Measure of variation of urinary urgency", "secondary_outcome": null, "secondary_id": "24C211", "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": 4315, "title": "A prospective longitudinal study of spinal cord lesions in multiple sclerosis: MRI monitoring and prognostic factors for active disease", "summary": null, "published_date": "2024-03-12T00:00:00Z", "discovery_date": "2024-03-28T14:55:24.711575Z", "link": "https://onderzoekmetmensen.nl/en/trial/56629", "source": "WHO XML import", "relevant": null, "identifiers": { "nl-omon": "NL-OMON56629" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13871760", "last_refreshed_on": "2024-04-09", "scientific_title": "A prospective longitudinal study of spinal cord lesions in multiple sclerosis: MRI monitoring and prognostic factors for active disease - MSpine", "primary_sponsor": "Zuyderland Medisch Centrum", "retrospective_flag": "Yes", "date_registration": null, "source_register": "NL-OMON", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "18", "inclusion_agemax": "64", "inclusion_gender": null, "date_enrollement": "2024-07-01", "target_size": "155", "study_type": "Observational invasive", "study_design": "Open (masking not used), Uncontrolled, Diagnostic", "phase": null, "countries": "Netherlands", "contact_firstname": null, "contact_lastname": null, "contact_address": "Dr. H. van der Hoffplein 1", "contact_email": null, "contact_tel": null, "contact_affiliation": "Zuyderland Medisch Centrum", "inclusion_criteria": "Inclusion criteria: <p>Patients diagnosed with relapsing-remitting MS (<5 years of first clinical <br>event)<br>Patient between 18-65 years old<br>Treatment-naïve patients starting (a currently in the Netherlands approved) DMT <br>(disease modifying treatment)</p>\r<br>", "exclusion_criteria": "Exclusion criteria: <p>Patients who are <18 years old <br>Patients who are >65 years old <br>Patients who presented first clinical event more than five years ago <br>Patients who have already started DMT<br>Patients who are incapable of giving informed consent <br>Patients who are unable to undergo local MRI scan, due to for instance: <br>Physical problems, for instance due to size/obesity (not fitting in regular MRI <br>scanner), not being able to lie flat for extended periods of time (e.g. due to <br>pain, shortness of breath). Due to claustrophobia.<br>Patients who have contraindications for MRI scan, for instance due to <br>MRI-unsafe or non-compatible implanted material/devices, such as pacemakers or <br>ocular metal splinters, or patients who are pregnant at inclusion.</p>\r<br>", "condition": "<br>MS <br>multiple sclerosis;10012303", "intervention": "<p></p><br>", "primary_outcome": "<p>1. What is the incidence of asymptomatic spinal cord lesions in patients<br /><br>commencing DMT?<br /><br>2. In the absence of radiological progression on brain imaging, how frequently<br /><br>do asymptomatic spinal cord lesions occur? In other words, how often is disease<br /><br>activity solely proven by spinal cord MRI and what is the<br /><br>number-needed-to-scan?</p><br>", "secondary_outcome": "<p>Secondary endpoints include which patient subgroups are prone to new spinal<br />\r<br>cord lesions at follow-up in early disease.</p>\r<br>", "secondary_id": "NL86278.096.24", "source_support": "Nationaal MS Fonds", "ethics_review_status": "Approved", "ethics_review_approval_date": "2024-12-03", "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": 4314, "title": "Social and Moral Cognition in Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Other: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment; Other: MS questionnaire; Other: MONTREAL COGNITIVE ASSESSMENT (MoCA) test\n<br /><b>Sponsors</b>: Lille Catholic University\n<br /><b>Recruiting</b>", "published_date": "2024-12-03T00:00:00Z", "discovery_date": "2024-03-28T14:55:24.688124Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06318923", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06318923", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13828376", "last_refreshed_on": "2024-04-01", "scientific_title": "Social and Moral Cognition in Multiple Sclerosis", "primary_sponsor": "Lille Catholic University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2023-12-19", "target_size": "90", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).", "phase": "N/A", "countries": "France", "contact_firstname": ";", "contact_lastname": "Béatrice DEGRAEVE;Marie Paule LEBITASY", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";03.20.22.57.41", "contact_affiliation": "Catholic University of Lille Faculty of Letters and Humanities;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Men or women aged 18 to 55.\r<br>\r<br> - Understanding and able to express themselves in French.\r<br>\r<br> - Characteristics according to groups:\r<br>\r<br> - MS patient group:\r<br>\r<br> - relapsing-remitting form (RRMS)\r<br>\r<br> - with EDSS = 4\r<br>\r<br> - with no significant motor, cerebellar or somesthesic disorders of the upper limbs\r<br> or visual disorders (specific EDSS parameter = 2)\r<br>\r<br> - absence of relapse in the last 6 weeks\r<br>\r<br> - Control groups:\r<br>\r<br> - absence of known global cognitive deterioration.\r<br>\r<br> - Understanding and signing of the informed consent and information letter concerning\r<br> participation in the study.\r<br>\r<br> - Beneficiary of health insurance coverage.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - People with previous neurological pathologies, head trauma with loss of consciousness,\r<br> known psychiatric pathologies (excluding anxiety-depressive syndrome), serious general\r<br> illnesses, perceptual or dysarthric disorders preventing verbal communication or\r<br> reading,\r<br>\r<br> - Severe cognitive impairment in MS patients, i.e. an SDMT score < -2.5 if the BICAMS\r<br> battery is present in the patient's file and is less than 6 months old.\r<br>\r<br> - Severe depressive syndrome, with a BDI-FS score > 10\r<br>\r<br> - People with sensory disorders (visual and auditory) that interfere with\r<br> neuropsychological testing;\r<br>\r<br> - Major sensory disorders or cerebellar syndrome\r<br>\r<br> - Sensory deficits (visual or auditory)\r<br>\r<br> - Treatment with psychotropic drugs\r<br>\r<br> - Adults under guardianship, curatorship, persons deprived of liberty.\r<br>\r<br> - Pregnant or breast-feeding women\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment;Other: MS questionnaire;Other: MONTREAL COGNITIVE ASSESSMENT (MoCA) test", "primary_outcome": "Moral dilemma judgments", "secondary_outcome": "Explicit time perspective inventory test;Implicit time perspective inventory test;Dot Probe Task;Level of moral permissibility;Level of emotional reactivity;Moral relativity level;Brief International Cognitive Assessment for Multiple Sclerosis;The Beck Depression Inventory;State-Trait Anxiety Inventory;Toronto Alexithymia Scale (TAS)-20;Empathy quotient-8 (EQ-8);Electrodermal response", "secondary_id": "RC-P00117", "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": 4313, "title": "Exploring associations between multiple sclerosis (MS) progress and diet.", "summary": null, "published_date": "2024-03-21T00:00:00Z", "discovery_date": "2024-03-28T14:55:24.653644Z", "link": "https://anzctr.org.au/ACTRN12624000296538.aspx", "source": "WHO XML import", "relevant": null, "identifiers": { "actrn": "ACTRN12624000296538" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13820264", "last_refreshed_on": "2024-03-25", "scientific_title": "Using objective clinical measures to explore the associations between disability progression and diet in adults with multiple sclerosis (MS): A prospective pilot study.", "primary_sponsor": "Illawarra Health and Medical Research Institute", "retrospective_flag": "No", "date_registration": null, "source_register": "ANZCTR", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "No limit", "inclusion_gender": "Both males and females", "date_enrollement": "2021-04-22", "target_size": "15", "study_type": "Observational", "study_design": "Duration: Longitudinal;Timing: Prospective;", "phase": "Not Applicable", "countries": "Australia", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: Diagnosed by a neurologist with relapsing remitting MS (RRMS) using the McDonald criteria, ability to speak and communicate in the English language and access to the Internet to complete the online dietary recalls.", "exclusion_criteria": "Exclusion criteria: Does not meet the above inclusion criteria.", "condition": "Multiple sclerosis, MS; <br>Multiple sclerosis, MS;Neurological - Multiple sclerosis;Diet and Nutrition - Other diet and nutrition disorders;Alternative and Complementary Medicine - Other alternative and complementary medicine;Neurological - Multiple sclerosis", "intervention": "This project will develop pilot data for n=15 people who have been diagnosed by a neurologist with MS using the McDonald criteria. People diagnosed with relapsing remitting MS will be recruited as part of their routine scan (6 monthly) which forms part of usual care for MS. All eligible people living with MS will be included regardless of time since diagnosis. Exclusion criteria, however, will be limited to an ability to speak and communicate in the English language. All eligible participants will complete one MRI scan using a research protocol designed specifically for this study. However, the team are not 'intervening' in any way and the research protocol is purely observational. Prior to attending the scan participants will be sent an online link to a dietary assessment tool to access the ASA-24 AU. The tool uses a recall of the previous 24 hour period of food and beverage intake using validated methodology, taking ~25 minutes to complete. A repeated 24-hour recall will occur within the same week as the MRI to allow for usual intake regression models to be created using the Multiple Source method. Participants will also complete a 5-10 minute interview-administered questionnaire to collect other details of lifestyle management behaviours and practices including physical activity, smoking status, self-perceived stress, height and weight to calculate body mass index, UV exposure, dietary pattern and the presence of comorbidities. These procedures, including a 33 minute MRI scan will be repeated to the 12-month time to monitor any changes that may occur over time. MRI scans will be assessed by two radiologists to determine the number of new and/or enlarging T2 lesions. The T1 images will also be run through a semi-automated pipeline using FreeSurfer software with manu", "primary_outcome": "Composite assessment of feasibility [The following will assessed as composite primary outcome measures of feasibility:<br>1. Evaluation of the proposed recruitment capability of the eligibility criteria via data obtained on the number of participants reaching out showing interest in the study, the number assessed for eligibility and reasons for ineligibility to participate;<br>2. Evaluation on the recruitment methods by identifying recruitment methods that reached all potential participants.<br>3. Participant retention rates by assessing the number enrolled at the commencement and the number of participants remaining at the end of the study period.<br>3. Quality and number of manual corrections required to be made by the researcher to the semi-automated neuroimaging output for volumetric analysis. This will be assessed via FreeSurfer output software and records by the researcher including the number of errors identified per participant and the time taken to manually correct errors.<br><br><br> At the conclusion of the data collection phase (i.e. 1-month post data collection of baseline assessment and volumetric analysis of neuroimaging output via FreeSurfer)];Composite assessment of acceptability [The following will be assessed as composite primary outcome measures of acceptability:<br>1. Assessment of participant burden through time to complete all study measures, via time data obtained from each participant to complete MRI sequence, dietary intake recalls and lifestyle questionnaire. These times will be added together for overall time burden.<br>2. Protocol burden by the time required for quality control checks and manual editing of brain images. This will be assessed by time records kept from the researcher when completing manual editing of brain images. At the conclusion of the data collection phase (i.e. 1-month post data collection of baseline assessment and volumetric analysis of neuroimaging output via FreeSurfer)]", "secondary_outcome": "Composite assessment of preliminary efficacy [Macronutrient and micronutrient intake, dietary pattern, lifestyle measures, T2-weighted white matter lesion count, T1-weighed whole brain volume, using lifestyle profiles and brain scans. Baseline and 12-months post completion of the ASA24AU assessment, lifestyle questionnaire and MRI scan. The lifestyle questionnaire was adapted from the 2018 Lifestyle and Environment Survey of the Australian MS Longitudinal Survey by the Menzies Institute for Medical Research, University of Tasmania. This questionnaire has been used for large-scale longitudinal studies in MS research to measure lifestyle behaviours of people living with MS.]", "secondary_id": "Nil known", "source_support": "Illawara Health and Medical Research Institute;Illawarra Health and Medical Research Institute", "ethics_review_status": "Approved", "ethics_review_approval_date": "2021-03-03", "ethics_review_contact_name": null, "ethics_review_contact_address": "University of Wollongong Human Research Ethics Committee", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": "2023-10-26", "results_url_link": null }, { "trial_id": 4312, "title": "*A Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and T-cell tolerizing effect of DC-TAB in healthy volunteers, after single and multiple dosing*", "summary": null, "published_date": "2009-11-12T00:00:00Z", "discovery_date": "2024-03-22T13:18:08.656636Z", "link": "https://onderzoekmetmensen.nl/en/trial/34913", "source": "WHO XML import", "relevant": null, "identifiers": { "nl-omon": "NL-OMON34913" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13811323", "last_refreshed_on": "2024-03-18", "scientific_title": "*A Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and T-cell tolerizing effect of DC-TAB in healthy volunteers, after single and multiple dosing* - A phase I trial with DC-TAB", "primary_sponsor": "Delta Crystallon BV", "retrospective_flag": "Yes", "date_registration": null, "source_register": "NL-OMON", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "18", "inclusion_agemax": "99", "inclusion_gender": null, "date_enrollement": "2009-12-04", "target_size": "76", "study_type": "Interventional", "study_design": "Randomized controlled trial, Double blinded (masking used), Placebo, Parallel, Treatment", "phase": null, "countries": "Netherlands", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Kendle International", "inclusion_criteria": "Inclusion criteria: <p>• you have given your written consent to take part in this study; <br>• you are between 18 and 55 years of age (inclusive); <br>• you are in good physical and mental health; <br>• your body weight must be appropriate in relation to your height; <br>•The use of suitable anti conception in the 3 months before start of the study and you will remain using this until 3 months after the study and/or you can not invoke an pregnancy (males) or you can not get pregnant (females) <br>• no abnormalities are diagnosed during the screening.</p>\r<br>", "exclusion_criteria": "Exclusion criteria: <p>•If you are pregnant, planning to get pregnant or breastfeeding; <br>•If you have relatives (1st degree) who have MS; <br>•If you smoke 5 or more cigarettes per day or are not able to stop smoking during the admission period; <br>•If you have abused drug (past and present) and or alcohol <br>•The use of prescribed medication in the 14 days before start of the study, except for hormone based anticonceptionals, standard vitamines and paracetamol; <br>•If you recieved a vaccination within the 4 weeks before the start of the study; <br>•you have taken part in another clinical drug study during the last 3 months prior to the study; <br>• you have donated blood in the three months before admission; <br>•you have donated plasma in the 7 days before admission; <br>•if you have recieved bloodproducts in the 6 month before start of start of the study; <br>• you are Hepatitis B, C or HIV positive; <br>If no immune response can be achieved by DC-TAB in your blood; <br>•you are not suitable to participate in this study according to the investigator.</p>\r<br>", "condition": "<br>Multiple sclerosis <br>nervous system disease;10007951", "intervention": "<p>The study consists of 2 parts. In Part 1, all subjects will receive a single <br>dose of study medication on day 1; in Part 2, different subjects will receive <br>medication once daily during 3 consecutive days. <br>In Part 1, four groups of subjects (n=10) will be studied in a dose-escalation <br>design. Each group of subjects will be randomized to receive either DC-TAB <br>(n=8) or placebo (n=2) once. <br>In Part 2, three groups of subjects (n=12) will be studied in a dose-escalation <br>design. Each group of subjects will be randomized to receive either DC-TAB <br>(n=9) or placebo (n=3) once daily on 3 consecutive days.</p><br>", "primary_outcome": "<p>To evaluate the safety and tolerability of DC-TAB following a single dose and<br /><br>following repeated dosing in healthy volunteers.</p><br>", "secondary_outcome": "<p>To assess the pharmacokinetics of DC-TAB following a single dose and following<br />\r<br>repeated dosing in healthy volunteers.<br />\r<br>To evaluate the T-cell tolerizing effect of DC-TAB in healthy volunteers. To<br />\r<br>evaluate levels of DC-TAB specific and -neutralizing antibodies.</p>\r<br>", "secondary_id": "2009-016817-68-NL;NL30321.040.09", "source_support": "Delta Crystallon BV", "ethics_review_status": "Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved", "ethics_review_approval_date": null, "ethics_review_contact_name": ";;;;;;;", "ethics_review_contact_address": ";;;;;;;", "ethics_review_contact_phone": ";;;;;;;", "ethics_review_contact_email": ";;;;;;;", "results_date_completed": null, "results_url_link": null }, { "trial_id": 4311, "title": "Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS)", "summary": null, "published_date": "2018-11-10T00:00:00Z", "discovery_date": "2024-03-22T13:17:41.583602Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-001896-19", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2018-001896-19-BG" }, "categories": [ { "category_id": 24, "category_description": "sg", "category_name": "IMU-838", "category_slug": "imu-838", "category_terms": [ "IMU-838" ], "article_count": 0 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13844276", "last_refreshed_on": "2024-04-02", "scientific_title": "Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS", "primary_sponsor": "Immunic AG", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Authorised", "other_records": "Yes", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2018-12-17", "target_size": "270", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): no", "countries": "Romania;Ukraine;Poland;Bulgaria;Germany", "contact_firstname": "Chief Medical Officer", "contact_lastname": null, "contact_address": "Lochhamer Schlag 21", "contact_email": "[email protected]", "contact_tel": "+49892500 79464", "contact_affiliation": "Immunic AG", "inclusion_criteria": "Inclusion criteria: <br>Main treatment period<br>1. Male or female patient (age =18 to 55 years, inclusive)<br>2. Diagnosis of RRMS according to the revised McDonald criteria (2017) <br>Note: The diagnosis of MS (including “dissemination in time”) must have been established before the patient is screened for the trial.<br>3. Disease activity evidenced<br>o by either at least 2 relapses in the last 24 months, or at least 1 relapse in the last 12 months before randomization (relapses must have been assessed and documented by a physician in the patient files), AND<br>o =1 documented Gd+ MS-related brain lesion, in the last 6 months before informed consent (date of MRI examination as well as copy of MRI report or representative image has to be available and accessible as patient source data at the study site)<br>4. Expanded Disability Status Scale (EDSS) score between 0 and 4.0 (inclusive) at Screening Visit 1<br>5. Female patients<br>o must be of non-child-bearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening Visit 1) or post-menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or<br>o if of child-bearing potential, must have a negative pregnancy test at Screening Visit 1 (blood test) and before the first IMP intake (Day 0 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (see below) together with a barrier method between trial consent and 30 days after the last intake of the of the IMP.<br>Highly effective forms of birth control are those with a failure rate less than 1% per year and include:<br>- oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation<br>- oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation<br>- intrauterine device or intrauterine hormone-releasing system<br>- bilateral tubal occlusion<br>- vasectomized partner (i.e. the patient’s male partner underwent effective surgical sterilization before the female patient entered the clinical trial and is the sole sexual partner of the female patient during the clinical trial)<br>- sexual abstinence (acceptable only if it is the patient’s usual form of birth control/lifestyle choice; periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods] and withdrawal are no acceptable methods of contraception)<br>Barrier methods of contraception include:<br>- Condom <br>- Occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository<br>6. Male patients must agree not to father a child or to donate sperm starting at Screening Visit 1, throughout the clinical trial and for 30 days after the last intake of the IMP. Male patients must also<br>o abstain from sexual intercourse with a female partner (acceptable only if it is the patient’s usual form of birth control/lifestyle choice), or<br>o use adequate barrier contraception during treatment with the IMP and until at least 30 days after the last intake of the IMP, and<br>o if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 5<br>o if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP<br>7. Willingness and ability to comply with the protocol<br>8. Writ", "exclusion_criteria": "Exclusion criteria: <br>MS-related exclusion criteria<br>1. Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis<br>2. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from these<br>3. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or MOG-associated encephalomyelitis (i.e. presence of anti-NMO [aquaporin-4] antibodies or anti-MOG-antibodies)<br>4. MS types other than RRMS<br>5. Any MRI finding, atypical for MS, including but not limited to a longitudinally extensive spinal cord lesion<br>6. Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)<br>7. An MS relapse within 30 days before Screening Visit 1 and/or during the screening period (until Day 0)<br>General exclusion criteria<br>32. Current or past (within 12 months of Screening Visit 1) alcohol or drug abuse<br>33. Any condition that would prevent the patient from undergoing an MRI scan, including:<br>o claustrophobic conditions<br>o unable to receive Gd-based MRI-contrast agents due to history of hypersensitivity to Gd-based contrast agents, or severe renal insufficiency<br>o presence of metallic implants incompatible with brain MRI<br>34 Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to understand the patient information and informed consent form<br>35. Pregnant or breastfeeding<br>36. An employee of an investigator or sponsor or an immediate relative of an investigator<br>37. Patients institutionalized due to judicial or administrative order<br><br>Exclusion criteria for optional extended treatment period<br>1. Any ongoing, clinically significant (as assessed by the investigator) treatment-emergent (started after intake of IMP) AE or laboratory a normality (including blood chemistry and urinalysis)7<br>2. Significant treatment or trial non-compliance during the main treatment period (as assessed by the investigator), and/or inability or unwillingness to follow instructions by trial personnel<br>3. Treatment compliance <70% during the main treatment period<br>4. Significant protocol deviations during the main treatment period that are assessed by the investigator to negatively affect further patient cooperation in this trial<br>", "condition": "relapsing-remitting multiple sclerosis <br>MedDRA version: 21.1\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: VIDOFLUDIMUS CALCIUM<br>Product Code: IMU-838<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Vidofludimus calcium<br>Current Sponsor code: IMU-838<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 15-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: VIDOFLUDIMUS CALCIUM<br>Product Code: IMU-838<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Vidofludimus calcium<br>Current Sponsor code: IMU-838<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 22.5-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: VIDOFLUDIMUS CALCIUM<br>Product Code: IMU-838<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Vidofludimus calcium<br>Current Sponsor code: IMU-838<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: VIDOFLUDIMUS CALCIUM<br>Product Code: IMU-838-RC<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Vidofludimus calcium<br>Current Sponsor code: IMU-838-RC<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 30-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: Cohort 1 (i.e. the main study): <br>Primary<br>• To evaluate the efficacy of 45 mg/day IMU-838 in the treatment of RRMS based on MRI assessments<br><br>Cohort 2 (i.e. the sub-study): <br>Primary<br>• To obtain more efficacy and safety data of IMU-838 in patients with RRMS and to allow pharmacodynamic modelling of the dose response.;Secondary Objective: Secondary<br>• To evaluate the efficacy of 30 mg/day IMU-838 in the treatment of RRMS based on magnetic resonance imaging (MRI) assessments <br>• To evaluate the safety and tolerability of 30 mg/day and 45 mg/day IMU-838 in RRMS patients<br><br><br>Tertiary<br>• To evaluate PD effects of IMU-838 in RRMS patients<br>• To evaluate IMU-838 trough values and population PK <br>• To evaluate the effects of IMU-838 on treatment satisfaction in patients with RRMS;Primary end point(s): Efficacy<br>Cohort 1 (C1): Difference between 45 mg/day IMU-838 and placebo in the cumulative number of combined unique active (CUA) MRI lesions up to Week 24<br>Cohort 2 (C2): Between-treatment differences in the cumulative number of CUA MRI and Gd+ lesions up to Week 24 ;Timepoint(s) of evaluation of this end point: Up to Week 24", "secondary_outcome": "Secondary end point(s): Key secondary (hierarchical testing to primary efficacy)<br>Efficacy<br>C1: Difference between 30 mg/day IMU-838 and placebo in the cumulative number of CUA MRI lesions up to Week 24 <br><br>Secondary<br>Efficacy<br>• C1: Difference between 45 mg/day IMU-838 and 30 mg/day IMU-838 in the cumulative number of CUA MRI lesions at Week 24 <br>• C1: Difference between 30 mg/day IMU-838 and placebo, 45 mg/day IMU-838 and placebo, and 30 mg/day and 45 mg/day IMU-838 for the following MRI parameters and C2: Between-treatment differences in the following MRI parameters:<br>o C1+C2: Mean number of CUA lesions per patient per scan at Weeks 6, 12, 18 and 24<br>o C1: Cumulative number of CUA MRI lesions up to Weeks 6, 12, and 18 <br>o C2: Cumulative number of CUA MRI lesions up to Weeks 6, 12, 18, and 24 <br>o C1: Volume changes of T2 lesions at Weeks 6, 12, 18 and 24 compared to Baseline<br>o C1+C2: T2-lesion load at Weeks 6, 12, 18 and 24 compared to Baseline<br>o C1+C2: T1-lesion load at Weeks 6, 12, 18 and 24 compared to Baseline<br>o C1+C2: Cumulative number of new Gd+ lesions up to Weeks 6, 12, 18 and 24<br>o C1+C2: Cumulative number of new T2 lesions up to Weeks 6, 12, 18 and 24<br>o C1+C2: Cumulative number of new T1 lesions up to Weeks 6, 12, 18 and 24<br>o C1+C2: Proportion of patients without new Gd+ lesions over 24 weeks <br>o C1+C2: Proportion of patients without new or enlarging T2-weighted lesions over 24 weeks<br>o C1: Proportion of patients with CUA lesions at Week 24<br>o C1: Proportion of patients with Gd+ lesions at Week 24<br>o C1: Proportion of patients with T2 lesions at Week 24 <br><br>• C1: Differences between individual treatments and between the pooled 30 mg/day and 45 mg/day groups and placebo in the following relapse-related clinical endpoints:<br>o Mean annualized relapse rate (during main and extended treatment period) <br>o Proportion of relapse-free patients up to Week 24 and at extended periods thereafter<br>o Time to relapse at time of final analysis of main part<br>• C2: Number of relapses in each treatment arm<br><br>• C1: Differences between treatments in changes of disease activity as measured by the following clinical parameters:<br>o Mean change in the EDSS as compared to Baseline during the main and extended period (every 12 weeks starting at Week 12) <br>o Proportion of patients with EDSS progression during the main and extended period (every 12 weeks starting at Week 12, and cumulatively)<br>• C2: Change of EDSS from Baseline to Weeks 12 and 24<br>• C1: Correlation of MRI-based assessments with quartiles of IMU-838 trough levels at Week 6 and Week 24<br>• C2: Correlation of MRI-based assessments with quartiles of IMU-838 trough levels at Week 24<br><br>Safety <br>• C1+C2: AEs, serious AEs and clinically significant laboratory abnormalities (as assessed by the investigator)<br>• C1+C2: AEs of special interest: <br>o Red blood cell urine positive, at least of moderate intensity<br>o Hematuria<br>o Retroperitoneal colicky pain with suspected or confirmed nephrolithiasis<br>• C1: Proportion of patients treated with 30 mg/day or 45 mg/day IMU 838 as compared to placebo who experienced at least one of the following AEs / C2: Proportion of patients treated with 10 mg/day as compared to placebo who experienced at least one of the following AEs:<br>o Neutropenia<br>o Lymphopenia<br>o Diarrhea<br>o Alopecia<br>o Hemorrhage<br>o Abnormalities in alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, and total bilirubin with both elevations > 1.5 x ULN and = 35% elevated compared to Baseline<br>• ECG, physical examination, and vital signs<br>• C1: Micro ribonucleic acid-122 expression (Change from Baseline to 4 hours after first dose)<br>• C1: Presence of John Cunningham virus (JCV) deoxyribonucleic acid (DNA) in urine in patients with detectable JCV-DNA in urine at Screening Visit 1, at Week 24, and at EoS<br>• C1+C2: Time to treatment discontinuation for any reason<br>• C1+C2: Rate of treatment discontinuations up to Week 24<br><br>Pharmacokinetics<br>• C1+C2: Population PK at Week 6 (3-10 hours post-dose)<br>• C1+C2: Plasma trough levels of IMU-838 at Days 7 and Weeks 6, 12, 18, and 24<br><br>Pharmacodynamics<br>• C1: Changes from Baseline in lymphocyte subset parameters as measured by flow cytometry at Weeks 6 and 24 (in selected Biomarker Centers only)<br>• C1: Changes from Baseline in biased T-cell clonal repertoire based on T-cell receptor deep sequencing at Weeks 6 and 24 (in selected Biomarker Centers only)<br>• C1+C2: Changes from Baseline in serum neurofilament at Week 24<br>• C2: Changes in serum C4 (7a-hydroxy-4-cholesten-3-one)<br>• C2: Changes in serum fibroblast growth factor 19 (FGF-19)<br><br>Health outcome (C1)<br>• Treatment Satisfaction Questionnaire for Medication at Week 6, Week 24 and EoS ;Timepoint(s) of evaluation of this end point: Key secondary (hierarchical testing to primary efficacy)<br>Efficacy: up to Week 24<br><br>Secondary<br>Efficacy: Baseline, Weeks 6, 12, 18 and 24<br>Safety: Screening, throughout Main and Extended Treatment Period, all Unscheduled Visits and EoS<br>Pharmacokinetics: Days 7 and Weeks 6, 12, 18, and 24<br>Pharmacodynamics: Baseline, Weeks 6 and 24<br>Health outcome: Week 6, Week 24 and EoS", "secondary_id": "P2-IMU-838-MS", "source_support": "Immunic AG", "ethics_review_status": "Approved", "ethics_review_approval_date": "2018-12-17", "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": 4310, "title": "An open-label study evaluating ofatumumab treatment effectiveness and\nPROs in subjects with RMS transitioning from fumarate-based RMS\napproved therapies or fingolimod to ofatumumab", "summary": null, "published_date": "2020-03-16T00:00:00Z", "discovery_date": "2024-03-22T13:17:35.151389Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001341-40", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2019-001341-40-SK" }, "categories": [ { "category_id": 39, "category_description": "ofatumumab, Kesimpta", "category_name": "Ofatumumab", "category_slug": "ofatumumab", "category_terms": [ "ofatumumab", "kesimpta" ], "article_count": 45 }, { "category_id": 1, "category_description": "Fingolimod, also known as Gilenya is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.\r\n\r\nhttps://www.ema.europa.eu/en/medicines/human/EPAR/gilenya", "category_name": "Fingolimod", "category_slug": "fingolimod", "category_terms": [ "fingolimod", "gilenya" ], "article_count": 259 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13811795", "last_refreshed_on": "2024-03-18", "scientific_title": "A single-arm, prospective, multicentre, open-label study to evaluate\nofatumumab treatment effectiveness and patient-reported outcomes (PRO)\nin patients with relapsing multiple sclerosis (RMS) transitioning from\nfumarate-based RMS approved therapies or fingolimod", "primary_sponsor": "Novartis Pharma AG", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Authorised", "other_records": "Yes", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2020-07-20", "target_size": "555", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): no\nTherapeutic confirmatory - (Phase III): yes\nTherapeutic use (Phase IV): no", "countries": "Russian Federation;United States;Czechia;Portugal;Saudi Arabia;Greece;Austria;Latvia;Poland;Slovakia;Slovenia;Bulgaria;France;Argentina;Hungary;United Kingdom;Switzerland;Spain;Lebanon;Canada;Czech Republic;Belgium;Norway;Mexico;Italy;Australia;Türkiye;Germany;Estonia", "contact_firstname": "DRA information desk", "contact_lastname": null, "contact_address": "Žižkova 22/B", "contact_email": "[email protected]", "contact_tel": "+421 2 50706116", "contact_affiliation": "Novartis Slovakia s.r.o.", "inclusion_criteria": "Inclusion criteria: <br>• Diagnosis of MS according to the 2017 Revised McDonald criteria<br>• Relapsing MS: relapsing forms of MS (RMS) including RMS and<br>secondary progressive MS (SPMS) (Lublin et al 2014)<br>• Disability status at screening defined by Expanded Disability Status<br>Scale (EDSS) score of 0 to 4 (inclusive)<br>• MS treatment history with a maximum of 3 Disease Modifying<br>Therapies (DMTs), where all fumarates are considered as one DMT<br>• Subject transitioning from either any fumarate-based RMS approved<br>therapies, such as dimethyl fumarate (DMF) or diroximel fumarate<br>(DRF), or fingolimod which was administered for a period of at least 6<br>months, as their last DMT before first study drug administration<br>• Breakthrough disease activity while the participant was adequately<br>using fumarates or fingolimod prior to transitioning for a minimum of 6<br>months as evidenced by one or more clinically reported relapses or one<br>or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+<br>enhancement, new or enlarging T2 lesions)<br>• Neurologically stable within one month prior to first study drug<br>administration<br><br>Please see protocol for complete detailed list of inclusion criteria.<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 555<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>• Subjects with primary progressive MS (Polman et al 2011) or SPMS<br>without disease activity (Lublin et al 2014)<br>• Subjects meeting criteria for neuromyelitis optica (Wingerchuk et al<br>2015)<br>• Disease duration of more than 10 years since diagnosis<br>• Pregnant or nursing(lactating) women<br>• Women of child-bearing potential unless they are using highly effective<br>forms of contraception during dosing and for at least 6 months after<br>stopping study medication<br>• Subjects with active chronic disease of the immune system other than<br>MS or with immunodeficiency syndrome<br>• Subjects with active systemic bacterial, fungal or viral infections (such<br>as hepatitis, HIV, COVID-19), or known to have Acquired<br>Immunodeficiency Syndrome (AIDS)<br>• Subjects with neurological symptoms consistent with Progressive<br>Multifocal Leukoencephalopathy (PML) or with confirmed PML<br>• Subjects at risk of developing or having reactivation of syphilis or<br>tuberculosis (e.g. subjects with known exposure to, or history of<br>syphilis, or active or latent tuberculosis, even if previously treated), as<br>confirmed by medical history or per local practice<br>• Subjects with active hepatitis B and C disease, assessed locally<br>• Have received any live or live-attenuated vaccines within 4 weeks prior<br>to first study drug administration<br>• Have been treated with medications as specified or within timeframes<br>specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab,<br>alemtuzumab, natalizumab, daclizumab, cyclophosphamide,<br>teriflunomide etc.)<br>• Subjects suspected of not being able or willing to cooperate or comply<br>with study protocol requirements in the opinion of the investigator<br><br>Please see protocol for complete detailed list of exclusion criteria.<br>", "condition": "Multiple sclerosis <br>MedDRA version: 20.0\nLevel: PT\nClassification code 10048393\nTerm: Multiple sclerosis relapse\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]", "intervention": "<br>Trade Name: Kesimpta<br>Product Name: ofatumumab<br>Product Code: OMB157<br>Pharmaceutical Form: Solution for injection in pre-filled pen<br>INN or Proposed INN: OFATUMUMAB<br>CAS Number: 679818-59-8<br>Current Sponsor code: OMB157<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 50-<br><br>", "primary_outcome": "Main Objective: Demonstrate the effectiveness of ofatumumab 20 mg s.c. administered<br>every 4 weeks in subjects with relapsing forms of MS who had<br>breakthrough disease on fumarates or fingolimod;Secondary Objective: Evaluate the safety of ofatumumab 20 mg s.c. administrated every 4<br>weeks in subjects with relapsing forms of MS who had breakthrough<br>disease on fumarates or fingolimod;Primary end point(s): Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks;Timepoint(s) of evaluation of this end point: 96 weeks", "secondary_outcome": "Secondary end point(s): • Proportion of subjects with adverse events, including injection related reactions<br>• Proportion of patients with laboratory or vital signs results meeting abnormal criteria<br>• The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons;Timepoint(s) of evaluation of this end point: 96 weeks", "secondary_id": "COMB157G23101;2019-001341-40-CZ", "source_support": "Novartis Pharma AG", "ethics_review_status": "Approved", "ethics_review_approval_date": "2020-07-20", "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": 4309, "title": "A Study to Evaluate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis", "summary": null, "published_date": "2021-09-14T00:00:00Z", "discovery_date": "2024-03-22T13:17:27.769324Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-003772-14", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2021-003772-14-SK" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13811843", "last_refreshed_on": "2024-03-18", "scientific_title": "A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO\nINVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS", "primary_sponsor": "F. Hoffmann-La Roche Ltd", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Authorised", "other_records": "Yes", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2021-08-12", "target_size": "102", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): no", "countries": "Czech Republic;Morocco;Czechia;Norway;Japan;Egypt;Slovakia;Slovenia;Kenya;Serbia;Croatia", "contact_firstname": "Trial Information Support Line-TISL", "contact_lastname": null, "contact_address": "Grenzacherstrasse 124", "contact_email": "[email protected]", "contact_tel": null, "contact_affiliation": "F. Hoffmann-La Roche Ltd", "inclusion_criteria": "Inclusion criteria: <br>• Participants who are aged 18 to 55 years inclusive at the time of signing Informed Consent Form<br>• A diagnosis of relapsing MS (RMS) in accordance with the revised 2017 McDonald Criteria and one of the following:<br>o At least two documented clinical relapses within the last 2 years or one documented clinical relapse within 12 months of screening (but not within the 30 days prior to screening)<br>o Documented evidence of the presence of at least one T1 Gd+ lesion on MRI in the 6 months prior to randomization (may include the screening MRI)<br>• Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points<br>• For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs during the treatment period and for 28 days after the final dose of fenebrutinib<br>• For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 28 days after the final dose of fenebrutinib to avoid exposing the embryo<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 102<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>•Disease duration of >10 years from the onset of symptoms and an EDSS score at screening <2.0<br>•A diagnosis of primary progressive MS or non-active secondary progressive MS<br>•Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to or during screening or treatment with oral anti-microbials within 2 weeks prior to or during screening<br>•History of progressive multifocal leukoencephalopathy (PML)<br>•History of cancer<br>•Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy >1 year prior to screening is not exclusionary<br>•Presence of other neurological disorders that could interfere with the diagnosis of MS or with the assessments of efficacy or safety during the study<br>•Evidence of clinically significant psychiatric, pulmonary, renal, hepatic, metabolic, gastrointestinal (GI), or cardiovascular disease, or endocrine disease<br>•Presence of the New York Heart Association Class III and Class IV criteria for congestive heart failure<br>•Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results<br>•Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT<br>•History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias<br>•Participants undergoing dialysis or estimated glomerular filtration rate <60 mL/min/1.73 m^2<br>•Any of the following laboratory results: ALT or AST >2*upper limit of normal (ULN); Total bilirubin greater than 1.5*ULN; Hemoglobin <9.5 grams/deciliter; White blood cell count <2000 cells/mm^3 (µL); Platelet count <100*10^9/L; Absolute neutrophil count <=1500 cells/mm^3 (µL); IgG<500 mg/dL<br>•Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the 12-week double-blind study period<br>•History of alcohol or other drug abuse within 12 months prior to screening<br>•Positive screening tests for hepatitis B<br>•Positive screening tests for hepatitis C<br>•Evidence of active, latent or inadequately treated infection with tuberculosis<br>•Clinically significant abnormalities in hepatic synthetic function tests<br>•History of hospitalization or transfusion for a GI bleed<br>•Known bleeding diathesis<br>•Any condition possibly affecting oral drug absorption<br>•History of or currently active primary or secondary (non-drug-related) immunodeficiency<br>•Inability to complete an MRI scan or contraindication to Gd administration<br>•Any previous history of organ transplantation<br>•Any previous treatment with bone marrow transplantation or hematopoietic stem cell transplantation<br>•Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening or during the screening period. Inhaled and topical corticosteroids are allowed.<br>•Receiving an unstable dosing regimen of proton pump inhibitors or H2-receptor antagonist during the screening phase and/or no plan to remain at a stable dose for the duration of study treatment<br>•Treatment with IVIg or plasmapheresis within 12 weeks prior to randomization<br>•Sensitivity or intolerance to any ingredient of fenebrutinib<br>•Receipt of a live-attenuated vaccine within 6 weeks prior to randomization<br>•Need for systemic anticoagulation (ora", "condition": "Relapsing Multiple Sclerosis <br>MedDRA version: 20.0\nLevel: PT\nClassification code 10048393\nTerm: Multiple sclerosis relapse\nSystem Organ Class: 10029205 - Nervous system disorders\n <br>MedDRA version: 21.0\nLevel: PT\nClassification code 10080700\nTerm: Relapsing multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Immune System Diseases [C20]", "intervention": "<br>Product Name: Fenebrutinib<br>Product Code: RO7010939<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: FENEBRUTINIB<br>Current Sponsor code: RO7010939<br>Other descriptive name: GDC-0853 <br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: • To evaluate the efficacy of fenebrutinib compared with placebo on the<br>total number of new gadolinium enhancing T1 magnetic resonance<br>imaging (MRI) lesions;Secondary Objective: • To evaluate the effect of fenebrutinib on MRI lesions<br>• To evaluate the safety of fenebrutinib compared with placebo<br>• To characterize the fenebrutinib pharmacokinetics (PK) profile;Primary end point(s): 1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 4, 8, and 12;Timepoint(s) of evaluation of this end point: 1. At Weeks 4, 8, and 12", "secondary_outcome": "Secondary end point(s): 1.Total number of new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12<br>2.Proportion of participants free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12<br>3.Incidence and severity of adverse events<br>4.Change from baseline in vital signs<br>5.Change from baseline in targeted clinical laboratory test results<br>6.Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale<br>7.Plasma concentration of fenebrutinib at specified timepoints;Timepoint(s) of evaluation of this end point: 1-2. At Weeks 4, 8, and 12<br>3. From the start of treatment until 28 days after the final dose of study treatment<br>4-5. Double blind period: Baseline (Week 0) to Week 12; Open label period: Baseline (Week 0) to Week 192<br>6. Double blind period: At Baseline (Day -28 to Day -1), Weeks 4, 8 and 12; Open label period: Baseline (Week 0), Weeks 12, 24, 48, and every 24 weeks thereafter up to week 192.<br>7.\tAt Days 1, 29, 57, 85, at early discontinuation visit<br>", "secondary_id": "GN43271;2021-003772-14-CZ", "source_support": "F. Hoffman-La Roche Ltd.", "ethics_review_status": "Approved", "ethics_review_approval_date": "2021-06-10", "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 } ] }