Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
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{ "count": 5145, "next": "http://api.gregory-ms.com/trials/?page=2", "previous": null, "results": [ { "trial_id": 4663, "title": "Conventional Multidisciplinary Gait Rehabilitation VR Robotic Self-balancing Based Gait Rehabilitation", "summary": "<b>Conditions</b>: Multiple Sclerosis; Gait Disorders, Neurologic\n<br /><b>Interventions</b>: Device: Robotic gait training; Other: tRHB\n<br /><b>Sponsors</b>: Multiple Sclerosis Center of Catalonia\n<br /><b>Enrolling by invitation</b>", "published_date": "2024-09-27T04:00:00Z", "discovery_date": "2024-10-03T20:12:27.739975Z", "link": "https://clinicaltrials.gov/study/NCT06615947?cond=Multiple+Sclerosis", "identifiers": { "nct": "NCT06615947", "euct": null, "eudract": null }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14348537", "last_refreshed_on": "2024-09-30", "scientific_title": "Clinical Trial to Compare Conventional Multidisciplinary Gait Rehabilitation With the Atalante Self-balancing Walking System in Patients With Multiple Sclerosis", "primary_sponsor": "Multiple Sclerosis Center of Catalonia", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "75 Years", "inclusion_gender": "All", "date_enrollement": "2023-02-28", "target_size": "60", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).", "phase": "N/A", "countries": "Spain", "contact_firstname": ";", "contact_lastname": "Xavier Montalban, PHD;Carmen Tur Gomez, PHD", "contact_address": null, "contact_email": ";", "contact_tel": ";", "contact_affiliation": "Multiple Sclerosis Center of Catalonia;Multiple Sclerosis Center of Catalonia", "inclusion_criteria": "Inclusion Criteria:\r\n\r\n - • Male or female, between 18 and 75 years of age.\r\n\r\n - Confirmed diagnosis of MS.\r\n\r\n - EDSS from 6.0 to 7.0.\r\n\r\n - Able to maintain the upright position on a daily basis.\r\n\r\n - Stable course of disease-modifying therapy over the past 6 months.\r\n\r\n - Clinical comorbidity asymptomatic (i.e., no underlying cardiovascular disease)\r\n\r\n - Height: between approximately 1.50 m. and 1.90 m.\r\n\r\n - Willingness to visit the Multiple Sclerosis Center of Catalonia (Cemcat) for\r\n testing and training.\r\n\r\n - Gait disorder conditioned by paresis or hemiparesis associated with ataxia or\r\n sensory problems.\r\n\r\n - Patient having given written consent.\r\n\r\nAtalante is able to accommodate the following limb lengths:\r\n\r\n - Thigh: 380-460mm.\r\n\r\n - Distance between the ground and the joint space of the knee (to be measured while\r\n wearing the shoes they intend to wear with Atalante):\r\n\r\n - 457-607mm for patient with an ankle dorsiflexion = 16°\r\n\r\n - 457-577mm for patient with an ankle dorsiflexion between 13° et 16°\r\n\r\n - 457-567mm for patient with an ankle dorsiflexion between 10° et 13°\r\n\r\n - 457-557mm for patient with an ankle dorsiflexion between 0° and 10°\r\n\r\n - Hip with less or equal to 460mm when seated.\r\n\r\n - Maximum weight: 90 kg.\r\n\r\nExclusion Criteria:\r\n\r\n - • Pregnancy.\r\n\r\n - Starting or switching from fampridine (Fampyra®) in the last 4 weeks.\r\n\r\n - Height and weight outside the secure standard of safe use, described in the\r\n safety guides.\r\n\r\n - Contraindications for Atalante training (eg, bone instability, history of\r\n osteoporosis or osteoporotic fractures).\r\n\r\n - Subjects under Corticosteroids treatment or relapse.\r\n\r\n - Changes in disease-modifying and symptomatic therapy for MS during the study\r\n period.\r\n\r\n - Subjects with psychiatric or cognitive comorbidities that may interfere with\r\n the trial.\r\n\r\n - Whose joint centers cannot be aligned Atalante's.\r\n\r\n - Ranges of motion below:\r\n\r\n - Knee: 5° extension, 110° flexion\r\n\r\n - Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion\r\n\r\n - Hip: 115° flexion, 15° extension, 17° abduction, 10° adduction, 10°\r\n\r\n - medial rotation, 20° lateral rotation\r\n\r\n - Severe spasticity (greater than Ashworth 3) or uncontrolled clonus.\r\n\r\n - Severe concurrent medical diseases: infections, circulatory, heart or lung,\r\n pressure sores.\r\n\r\n - Active implantable medical device.", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Gait Disorders, Neurologic", "intervention": "Device: Robotic gait training;Other: tRHB", "primary_outcome": "Timed 10-meters walk test (10-MWT),", "secondary_outcome": null, "secondary_id": "PR(AG)05/2023", "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": 4662, "title": "Deuterium Metabolic Imaging in People with Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis (MS) - Relapsing-remitting\n<br /><b>Interventions</b>: Other: No Interventions\n<br /><b>Sponsors</b>: University of Aarhus\n<br /><b>Not yet recruiting</b>", "published_date": "2024-09-24T04:00:00Z", "discovery_date": "2024-10-03T20:12:19.233969Z", "link": "https://clinicaltrials.gov/study/NCT06611280?cond=Multiple+Sclerosis", "identifiers": { "nct": "NCT06611280", "euct": null, "eudract": null }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14348178", "last_refreshed_on": "2024-09-30", "scientific_title": "Deuterium Metabolic Imaging in People with Multiple Sclerosis", "primary_sponsor": "University of Aarhus", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "60 Years", "inclusion_gender": "All", "date_enrollement": "2024-10-01", "target_size": "20", "study_type": "Observational", "study_design": null, "phase": null, "countries": null, "contact_firstname": "", "contact_lastname": "Tobias Gæmelke, PhD-stud", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "4528264508", "contact_affiliation": null, "inclusion_criteria": "Inclusion Criteria:\r\n\r\n - Aged 18-60 years.\r\n\r\n - Definite Relapsing remitting multiple sclerosis diagnosis according to the most\r\n recent diagnostic criteria\r\n\r\nExclusion Criteria:\r\n\r\n - Contraindications for MRI:\r\n\r\nPacemaker, neurostimulator or cholera implant. Metal foreign bodies such as fragments and\r\nirremovable piercings. Unsafe medical implants (safety of heart valves, hips and the like\r\nmust be confirmed).\r\n\r\nClaustrophobia. Largest circumference including arms > 160 cm\r\n\r\n - Pregnancy\r\n\r\n - Competing neurological, psychiatric, or systemic diseases including diabetes (except\r\n prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and\r\n hyperlipidemia/cholesterolemia which are allowed).\r\n\r\n - Participating in other clinical trials with investigational medical products or\r\n drugs.", "exclusion_criteria": null, "condition": "Multiple Sclerosis (MS) - Relapsing-remitting", "intervention": "Other: No Interventions", "primary_outcome": "lactate to glx ratio", "secondary_outcome": "Six-minute walk test;25 meter walk test;Six-spot-step-test;Handgrip strength;5-sit-to-stand;Processing speed - Selective reminding test;Memory function - Symbol digit modality test;Glukose level;Lactat level;Glucose uptake;glucose to glx ratio;Clinical information on multiple sclerosis - Disease modifying treatment;Clinical information on multiple sclerosis - Time since diagnosis;Modified Fatigue Impact Scale;Clinical information on multiple sclerosis - Expanded disability status score;Multiple Sclerosis Impact Scale", "secondary_id": "DMI in MS", "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": 4661, "title": "Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Behavioral: Learning and memory training; Behavioral: Sham Comparator\n<br /><b>Sponsors</b>: Kessler Foundation\n<br /><b>Not yet recruiting</b>", "published_date": "2024-09-23T04:00:00Z", "discovery_date": "2024-10-03T20:12:19.008010Z", "link": "https://clinicaltrials.gov/study/NCT06608797?cond=Multiple+Sclerosis", "identifiers": { "nct": "NCT06608797", "euct": null, "eudract": null }, "team_categories": [ { "id": 14, "category_name": "Physical therapy and Telerehabilitation", "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ] } ], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14347987", "last_refreshed_on": "2024-09-30", "scientific_title": "Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community", "primary_sponsor": "Kessler Foundation", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "19 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2024-10-10", "target_size": "40", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).", "phase": "N/A", "countries": null, "contact_firstname": "", "contact_lastname": "Silvana L Costa PhD, PhD", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "973 324 8458", "contact_affiliation": null, "inclusion_criteria": "Inclusion Criteria:\r\n\r\n - English as primary language\r\n\r\n - Diagnosis of multiple sclerosis\r\n\r\nExclusion Criteria:\r\n\r\n - Most recent exacerbation within one month\r\n\r\n - Other Neurological History: head injury, stroke, seizures, or any other significant\r\n neurological history will not be included in the study\r\n\r\n - Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia,\r\n Bipolar Disorder I or II will be excluded from the study.\r\n\r\n - Poor Visual Acuity (corrected vision in worse eye &lt; 20/60), diplopia, or\r\n nystagmus\r\n\r\n - Inability to understand directions and following one, two, and three step commands\r\n\r\n - Intact New Learning and Memory: Only individuals that show impaired performance on a\r\n memory test will be included in the study", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Behavioral: Learning and memory training;Behavioral: Sham Comparator", "primary_outcome": "California Learning Verbal Test III", "secondary_outcome": "Ecological Memory Simulations", "secondary_id": "E-1259-24", "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": 4660, "title": "Upper Limb Muscle Strength Models for Patients with Motor Impairment.", "summary": "<b>Conditions</b>: Stroke; Multiple Sclerosis; Spinal Cord Injuries\n<br /><b>Interventions</b>: Other: Upper limb isokinetic forces measurements\n<br /><b>Sponsors</b>: Pôle Saint Hélier\n<br /><b>Not yet recruiting</b>", "published_date": "2024-09-23T04:00:00Z", "discovery_date": "2024-10-03T20:12:18.935699Z", "link": "https://clinicaltrials.gov/study/NCT06608121?cond=Multiple+Sclerosis", "identifiers": { "nct": "NCT06608121", "euct": null, "eudract": null }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14347935", "last_refreshed_on": "2024-09-30", "scientific_title": "Study for the Development and Evaluation of Personalised Muscle Effort Generation Models for Patients with Upper Limb Motor Deficits", "primary_sponsor": "Pôle Saint Hélier", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "85 Years", "inclusion_gender": "All", "date_enrollement": "2024-10-04", "target_size": "60", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).", "phase": "N/A", "countries": "France", "contact_firstname": "", "contact_lastname": "Emilie LEBLONG, MD", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "+33299295099", "contact_affiliation": null, "inclusion_criteria": "Inclusion Criteria:\r\n\r\n - Patients aged between 18 and 85\r\n\r\n - A patient who is a member or beneficiary of a social security scheme\r\n\r\n - Patients hospitalised at the Saint-Hélier rehabilitation centre for a stroke more\r\n than 15 days old, MS or SCI\r\n\r\n - Patients with a motor deficit =3/5 on the MRC (Medical Research Council) scale in\r\n both internal-external shoulder rotation and elbow flexion-extension.\r\n\r\n - Patient with voluntary consent to participate in this study.\r\n\r\nExclusion Criteria:\r\n\r\n - Spasticity >3/4 on the Aschworth scale in the shoulder abductor or elbow flexor\r\n muscles.\r\n\r\n - Cognitive impairment that may interfere with measurements (MOCA < 20/30)\r\n\r\n - Presence of a pressure sore > stage 2 at the ischial level\r\n\r\n - Recent trauma to limbs or spine\r\n\r\n - Decompensated heart disease or other unbalanced pathology which contraindicates or\r\n may hinder isokinetic testing.\r\n\r\n - Persons deprived of their liberty by a judicial or administrative decision\r\n\r\n - Pregnant women, women in labour or nursing mothers.", "exclusion_criteria": null, "condition": "Stroke;Multiple Sclerosis;Spinal Cord Injuries", "intervention": "Other: Upper limb isokinetic forces measurements", "primary_outcome": "Description of the residuals of the effort generation models, defined as the difference between the actual effort values and the modelled values: o Average residual of the models (mean ± standard deviation) (Main Evaluation Criterion)", "secondary_outcome": null, "secondary_id": "2024-A01007-40", "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": 4659, "title": "Pilates, Yoga and Tai Chi Exercises' Effect on Balance and Gait in Patients With Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Other: pilates exercises; Other: yoga exercises; Other: tai chi exercises; Other: tradional physical therapy\n<br /><b>Sponsors</b>: Cairo University\n<br /><b>Not yet recruiting</b>", "published_date": "2024-09-25T04:00:00Z", "discovery_date": "2024-10-03T20:12:18.888776Z", "link": "https://clinicaltrials.gov/study/NCT06612138?cond=Multiple+Sclerosis", "identifiers": { "nct": "NCT06612138", "euct": null, "eudract": null }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14348244", "last_refreshed_on": "2024-09-30", "scientific_title": "Pilates, Yoga and Tai Chi Exercises' Effect on Balance and Gait in Patients With Multiple Sclerosis", "primary_sponsor": "Cairo University", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "All", "date_enrollement": "2024-10-10", "target_size": "120", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).", "phase": "N/A", "countries": null, "contact_firstname": "", "contact_lastname": "Alshaymaa s Abd el-azeim, phd", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "01033771553", "contact_affiliation": null, "inclusion_criteria": "Inclusion Criteria:\r\n\r\n - A score of 3.5 or less on the Expanded Disability Status Scale (EDSS) because\r\n individuals with an EDSS score greater than 3.5 need more assistance, being less\r\n independent (Zorina et al.,2020).\r\n\r\n - All patients are taking their conventional medical treatment of relapsing-remitting\r\n stage\r\n\r\n - Age over than 18 years\r\n\r\n - All definite multiple sclerosis patients diagnosed as MS according to revised\r\n McDonald criteria 2017 .\r\n\r\n - Both males and females will be included\r\n\r\n - All Patients will be referred from neurologist.\r\n\r\nExclusion Criteria:\r\n\r\nPatients will be excluded if their diagnosis is not clearly established, if they suffer\r\nfrom an acute relapse or severe cognitive deficits, or have signs of any psychiatric\r\ndisease -Brain surgery/trauma/history of brain disease (stroke), other independent\r\nneurological history\r\n\r\n - Another exclusion criterion is the history of cardiac, pulmonary, orthopedic,or\r\n other medical conditions diagnosed before participation\r\n\r\n - Rheumatic diseases and other acute or chronic inflammations\r\n\r\n - Vascular disease, spinal cord compression, vitamin B 12 deficiency\r\n\r\n - Other conditions that affect the smooth progress of the inspection: such as hearing\r\n impairment, comprehension impairment, poor compliance\r\n\r\n - Alcoholism or drug dependence (addiction)\r\n\r\n - Pregnancy", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: pilates exercises;Other: yoga exercises;Other: tai chi exercises;Other: tradional physical therapy", "primary_outcome": "balance;gait assessment;exercise capacity", "secondary_outcome": "functional mobility;fatigue;life disability", "secondary_id": "P.T.REC/012/005332", "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": 4658, "title": "An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis", "summary": "<b>Conditions</b>: Relapsing Multiple Sclerosis\n<br /><b>Interventions</b>: Biological: rapcabtagene autoleucel (YTB323)\n<br /><b>Sponsors</b>: Novartis Pharmaceuticals\n<br /><b>Not yet recruiting</b>", "published_date": "2024-09-27T04:00:00Z", "discovery_date": "2024-10-03T20:12:18.839938Z", "link": "https://clinicaltrials.gov/study/NCT06617793?cond=Multiple+Sclerosis", "identifiers": { "nct": "NCT06617793", "euct": null, "eudract": null }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14348679", "last_refreshed_on": "2024-09-30", "scientific_title": "An Open-label, Multi-center, Phase 1/2 Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Participants With Relapsing Multiple Sclerosis With Breakthrough Disease Activity During Previous Treatment With a Highly Efficacious Therapy", "primary_sponsor": "Novartis Pharmaceuticals", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2025-01-02", "target_size": "28", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 1/Phase 2", "countries": null, "contact_firstname": ";", "contact_lastname": "Novartis Pharmaceuticals;Novartis Pharmaceuticals", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";+41613241111", "contact_affiliation": "Novartis Pharmaceuticals;", "inclusion_criteria": "Inclusion Criteria:\r\n\r\n - Signed informed consent, and able to communicate well with the investigator and\r\n comply with the requirements of the study\r\n\r\n - Adequate renal, hepatic, cardiac, hematological, and pulmonary function\r\n\r\n - Male or female participants, =18 years to =55 years at screening, with diagnosis of\r\n RMS according to the 2017 McDonald diagnostic criteria Evidence of recent (i.e.\r\n within 1 year) breakthrough disease activity while at least 6 months on a highly\r\n efficacious therapy (any of the following): rituximab (Rituxan®), ocrelizumab\r\n (Ocrevus®), natalizumab (Tysabri®), ofatumumab (Kesimpta®), ublituximab (Briumvi®)\r\n or alemtuzumab (Lemtrada®).\r\n\r\nEvidence of breakthrough disease activity is defined as one or more of the following:\r\n\r\n 1. Confirmed Clinical MS relapse\r\n\r\n 2. Persistent radiological activity defined by one of the following:\r\n\r\n - =2 T1 gadolinium-enhancing lesions on a single MRI scan\r\n\r\n - =1 T1 gadolinium-enhancing lesions on two or more separate MRI scans\r\n\r\n - =2 new T2 lesions compared to a previous scan within a period =1 year\r\n\r\n - Ambulatory patients (EDSS <6.5) (assessed outside of relapse)\r\n\r\n - Disease duration less than 10 years\r\n\r\nExclusion Criteria:\r\n\r\n - Diagnosis of primary progressive multiple sclerosis (PPMS) according to the 2017\r\n revision of the McDonald diagnostic criteria at screening\r\n\r\n - History of clinically significant CNS disease (e.g. stroke, traumatic brain or\r\n spinal injury, history or presence of myelopathy) or neurological disorders which\r\n may mimic MS at screening\r\n\r\n - Evidence of clinically significant cardiovascular (such as but not limited to\r\n myocardial infarction, unstable ischemic heart disease, New York Heart Association\r\n (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled\r\n hypertension within 6 months prior to screening), neurological, psychiatric,\r\n pulmonary (including, history of or active severe respiratory disease, including\r\n Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary\r\n fibrosis), renal, hepatic, endocrine, metabolic (e.g. severe hypoproteinemia due to\r\n nephrotic syndrome), hematological disorders or gastrointestinal disease that, in\r\n the investigator's opinion, would compromise the safety of the participant,\r\n interfere with the interpretation of the study results or otherwise preclude\r\n participation or protocol adherence of the participant, prior to screening\r\n\r\n - Have donated blood or experienced a loss of blood > 400 mL within 3 months prior\r\n screening, or longer if required by local regulations\r\n\r\n - Any prior stem cell therapy or organ transplantation\r\n\r\n - Any contraindications to LP, including but not limited to:\r\n\r\n - Known or suspected structural abnormality of the lumbar spine that, in the\r\n opinion of the Investigator, may interfere with the performance of the LP, or\r\n increase the risk of the procedure for the participant\r\n\r\n - Presence of risk for increased or uncontrolled bleeding including, but not\r\n limited to, vascular abnormalities or neoplasms at or near the LP site,\r\n disorders of the coagulation cascade, platelet function, or platelet count\r\n\r\n - Participants on anticoagulants (e.g., warfarin) or antiplatelets [except for\r\n low-dose aspirin (100 mg/day or lower) and low-dose ibuprofen (600 mg/day or\r\n lower) which are allowable], are not eligible to participate, unless temporal\r\n suspension of the anticoagulant or antiplatelet treatment for the purpose of\r\n the LP is considered safe for the patient, feasible, and guided by a\r\n hematologist\r\n\r\n - Patients not willing or able to take MRI scans as per protocol. Unable to undergo\r\n MRI due to for example claustrophobia, or presents absolute contraindications to MRI\r\n (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)\r\n\r\nOther protocol-defined inclusion/exclusion criteria may apply", "exclusion_criteria": null, "condition": "Relapsing Multiple Sclerosis", "intervention": "Biological: rapcabtagene autoleucel (YTB323)", "primary_outcome": "Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)", "secondary_outcome": "Measure of Disability: Expanded Disability Status Scale (EDSS).;Measure of Disability: Short Form Health Survey (SF-36 v2);Measure of Disability: Timed 25 Foot Walk (T25FW);Measure of Disability: 9 Hole Peg Test (9HPT);Measure of Disability: Symbol Digit Modalities Test (SDMT);Measure of Disability: Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS);Number of new and enlarging T2 lesions and Gd-enhancing T1 Lesions;Plasma Pharmacokinetics (PK) of YTB323 - CMAX;Plasma Pharmacokinetics (PK) of YTB323 - AUC;Plasma Pharmacokinetics (PK) of YTB323 - Tmax;Plasma Pharmacokinetics (PK) of YTB323 - Clast;Plasma Pharmacokinetics (PK) of YTB323 - Tlast;Humoral Immunogenicity of YTB323;Cellular Immunogenicity of YTB323;Manufacture success (defined as meeting release specifications and at or above the target dose)", "secondary_id": "2024-512714-18;CYTB323N12101", "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": 4657, "title": "Effects of Personalised Exercise Rehabilitation FOR people with Multimorbidity and cardiac or pulmonary disease: the PERFORM-CPR trial.", "summary": null, "published_date": "2024-09-30T00:00:00Z", "discovery_date": "2024-10-03T20:12:18.761649Z", "link": "https://anzctr.org.au/ACTRN12624001191583.aspx", "identifiers": { "actrn": "ACTRN12624001191583" }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14348807", "last_refreshed_on": "2024-09-30", "scientific_title": "Impact of Personalised Exercise Rehabilitation FOR people with Multimorbidity and cardiac or pulmonary disease on quality of life compared to standard cardiac and pulmonary rehabilitation: The PERFORM-CPR trial", "primary_sponsor": "Monash University", "retrospective_flag": "Yes", "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": "2024-01-10", "target_size": "604", "study_type": "Interventional", "study_design": "Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;", "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: Adults aged 18 years\r\nAble and willing to provide informed consent\r\nIndependently ambulant (including the use of walking aids) \r\nScores in the modified Medical Research Council dyspnoea scale => 2 OR New York Heart Association classification => II \r\nCardiac or pulmonary chronic conditions such as post myocardial infarction, post cardiac revascularization, stable angina, heart failure, COPD, bronchiectasis, and asthma\r\nIn addition, one of the following long-term health conditions: \r\n- arthritis\r\n- atrial fibrillation\r\n- cancer\r\n- chronic kidney disease\r\n- connective tissue disease (pain)\r\n- mild dementia (less than or equal to four errors in the Short Portable Mental Status Questionnaire)\r\n- depression\r\n- diabetes mellitus\r\n- hypertension,\r\n- long-COVID\r\n- multiple sclerosis\r\n- osteoporosis\r\n- painful condition due to chronic musculoskeletal conditions: osteoarthritis (hand, hip, and knee), chronic back and neck pain, shoulder impingement, and rotator cuff degeneration\r\n- Parkinson’s disease\r\n- peripheral vascular disease\r\n- polycystic ovarian syndrome\r\n- psychoactive substance misuse\r\n- stroke or transient ischaemic attack. \r\n\r\nPatients can also have one of the following conditions from the list below:\r\n- anorexia nervosa or bulimia\r\n- anxiety\r\n- atrial fibrillation\r\n- chronic fatigue syndrome\r\n- chronic liver disease\r\n- chronic sinusitis\r\n- diverticular disease\r\n- endometriosis, epilepsy\r\n- glaucoma\r\n- inflammatory bowel disease\r\n- irritable bowel syndrome\r\n- Meniere’s disease\r\n- migraines\r\n- pernicious anaemia\r\n- prostate disorders\r\n- psoriasis or eczema\r\n- schizophrenia or bipolar affective disorder\r\n- thyroid disease\r\n- treated constipation\r\n- treated dyspepsia\r\n- viral hepatitis", "exclusion_criteria": "Exclusion criteria: Unable to communicate in English\r\nKnown contraindications to exercise (as defined by the American College of Sports Medicine, Ed. 2021): unstable cardiac disease, current fever, and significant aortic aneurysm (more than 5.5 cm).\r\nUnable to attend in-person training sessions \r\nParticipation in a exercised rehabilitation programme in the last 6 months \r\nUnstable psychiatric disorder that limits or disrupts group based interventions \r\nActive malignancy (on chemotherapy/radiotherapy/planned urgent surgery) with a prognosis of less than 12 months survival\r\nPregnancy\r\nLiving in a residential aged care facility\r\nUnsafe to exercise in a group without 1:1 supervision (e.g. significant risk of falls)", "condition": "Post myocardial infarction ;Post cardiac revascularization ;Stable angina;Heart failure ;Chronic Obstructive Pulmonary Disease (COPD);Bronchiectasis;Asthma ;Cancer;Interstitial lung disease; <br>Post myocardial infarction <br>Post cardiac revascularization <br>Stable angina <br>Heart failure <br>Chronic Obstructive Pulmonary Disease (COPD) <br>Bronchiectasis <br>Asthma <br>Cancer <br>Interstitial lung disease;Metabolic and Endocrine - Diabetes;Mental Health - Depression;Cancer - Any cancer;Cardiovascular - Hypertension;Inflammatory and Immune System - Connective tissue diseases;Musculoskeletal - Osteoarthritis;Neurological - Multiple sclerosis;Neurological - Parkinson's disease;Neurological - Other neurological disorders;Metabolic and Endocrine - Metabolic disorders", "intervention": "Participants randomised to the PERFORM intervention will undergo an 8-week in-person supervised program at a rehabilitation centre, with sessions held twice weekly. Each session will last 2 hours and consist of one hour of exercise training (Move and Improve) and another hour focusing on patient self-care support and education (Health and Wellbeing sessions). <br>Staff will receive at least 4 hours of training in delivery of the PERFORM intervention, delivered in hybrid format (F2F and online), prior to enrolling the first participant.<br><br>Move and Improve: The exercise program will be based on the American College of Sports Medicine's guideline (Exercise management for persons with chronic diseases and disabilities). It will be supervised by seasoned physiotherapists/exercise physiologists with at least five years of experience. <br>The exercise program will feature personalized and progressive aerobic and resistance training. Aerobic training will consist of walking (treadmill or corridor) and cycle training for up to 30 minutes in a moderate intensity (Borg RPE scale rates exertion between 12 to 14 or Borg breathlessness scale, range 3-4). The resistance training will consist of lower limb and upper limb dumbbell exercises prescribed as tolerated to achieve 2–3 sets of 10 – 15 repetitions of each exercise. <br>Participants will receive a comprehensive exercise booklet and a standardized progress-tracking diary to encourage their involvement in a home exercise routine. In the progress-tracking diary, participants will document exercise frequency, duration, and post-exercise symptom evaluations for aerobic and resistance training.<br><br>The fidelity of Move and Improve component will involve three steps: <br>- Staff Training: The Move and Improvement program staff", "primary_outcome": "Health-related quality of life [EQ-5D-5L. Baseline and end intervention (3 months)]", "secondary_outcome": "Exercise capacity[Six-minute walk distance (6MWD) Baseline, end intervention (3 months) and 12 months];Mental health (depression)[Patient Health Questionnaire-9 (PHQ-9) Baseline, end intervention (3 months), and 12-month follow-up];Self-reported physical activity[International Physical Activity Questionnaire (IPAQ – short form) Baseline, end intervention (3 months), and 12-month follow-up];Treatment Burden[Multimorbidity Treatment Burden Questionnaire\r\n\r\n Baseline, end intervention (3 months), and 12-month follow-up];Fatigue\r\n\r\n[Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) Baseline, end intervention (3 months), and 12-month follow-up];Musculoskeletal pain[Brief Pain Inventory (BPI) Baseline, end intervention (3 months), and 12-month follow-up\r\n];Breathlessness\r\n\r\n[Dyspnoea-12 questionnaire Baseline, end intervention (3 months), and 12-month follow-up\r\n];Physical frailty\r\n\r\n[Self-reported exhaustion will be assessed using two questions from the Center for Epidemiologic Studies Depression (CES-D) scale. Participants will indicate whether they feel that everything they do is an effort and how often they felt this way in the past week (question 1). They will also respond regarding their feeling of not getting going and the frequency of this feeling over the last week (question 2). Baseline, end intervention (3 months), and 12-month follow-up];Exercise adherence\r\n \r\n\r\n[Exercise Adherence Rating Scale (EARS) End intervention (3 months), and 12-month follow-up];Adverse events. \r\nPossible adverse events are related to exercise training and include musculoskeletal injuries or other injuries attributable to study intervention, chest pain, syncope symptoms or fall fall during exercise session, hypertensive/hypotensive response, dizziness, lightheadedness, and cardiac arrhythmias. \r\n\r\n \r\n \r\n\r\n[AE log. From randomisation, end intervention (3 months) and 12-month follow-up];Functional capacity[Short Physical Performance Battery (SPPB) Baseline, end intervention (3 months), and 12 months];Anxiety [Generalised Anxiety Disorder Assessment-7 (GAD-7) tool Baseline, end intervention (3 months), and 12 months];Health-related quality of life[EQ-5D-5L 12 months after randomisation]", "secondary_id": "None", "source_support": "Department of Health and Aged Care: Medical Research Future Fund - Clinical Trials Activity Initiative - International Clinical Trial Collaborations", "ethics_review_status": "Approved", "ethics_review_approval_date": "2024-05-22", "ethics_review_contact_name": "Alfred Hospital Ethics Committee", "ethics_review_contact_address": "https://www.alfredhealth.org.au/research/ethics-research-governance", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 4656, "title": "Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)", "summary": null, "published_date": "2020-05-28T00:00:00Z", "discovery_date": "2024-09-27T12:58:25.858198Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04410978", "identifiers": { "nct": "NCT04410978" }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14327593", "last_refreshed_on": "2024-09-23", "scientific_title": "A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis", "primary_sponsor": "Sanofi", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "Yes", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2020-06-30", "target_size": "974", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).", "phase": "Phase 3", "countries": "United States;Austria;Belarus;Bulgaria;Canada;China;Czechia;Denmark;Estonia;Finland;Germany;Hong Kong;Italy;Japan;Lithuania;Mexico;Poland;Romania;Russian Federation;Spain;Sweden;Taiwan;Turkey;Ukraine;Austria;Belarus;Bulgaria;Canada;China;Czechia;Denmark;Estonia;Finland;Germany;Hong Kong;Italy;Japan;Lithuania;Mexico;Poland;Romania;Russian Federation;Spain;Sweden;Taiwan;Turkey;Ukraine;United States", "contact_firstname": "", "contact_lastname": "Clinical Sciences & Operations", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Sanofi", "inclusion_criteria": "Inclusion criteria :\r<br>\r<br> - The participant must be 18 to 55 years of age, inclusive, at the time of signing the\r<br> informed consent\r<br>\r<br> - The participant must have been diagnosed with RMS according to the 2017 revision of\r<br> the McDonald diagnostic criteria\r<br>\r<br> - The participant has an expanded disability status scale (EDSS) score =5.5 at the\r<br> first Screening Visit\r<br>\r<br> - The participant must have at least 1 of the following prior to screening:\r<br>\r<br> - =1 documented relapse within the previous year OR\r<br>\r<br> - =2 documented relapses within the previous 2 years, OR\r<br>\r<br> - =1 documented Gd enhancing lesion on an MRI scan within the previous year\r<br>\r<br> - Contraceptive use by men or women should be consistent with local regulations\r<br> regarding the methods of contraception for those participating in clinical studies\r<br>\r<br> - Male participants are eligible to participate if they agree to the following during\r<br> the intervention period and until accelerated elimination procedure:\r<br>\r<br> - Refrain from donating sperm\r<br>\r<br>Plus either:\r<br>\r<br> - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle\r<br> (abstinent on a long term and persistent basis) and agree to remain abstinent OR\r<br>\r<br> - Must agree to use contraception/barrier as detailed below:\r<br>\r<br>Agree to use a male condom and should also be advised of the benefit for a female partner\r<br>to use a highly effective method of contraception as a condom may break or leak when\r<br>having sexual intercourse with a woman of childbearing potential (WOCBP) who is not\r<br>currently pregnant\r<br>\r<br> - A female participant is eligible to participate if she is not pregnant or\r<br> breastfeeding, and at least one of the following conditions apply:\r<br>\r<br> - Is not a WOCBP OR\r<br>\r<br> - Is a WOCBP and agrees to use a contraceptive method that is highly effective\r<br> (with a failure rate of <1% per year), preferably with low user dependency,\r<br> during the intervention period and until accelerated elimination procedure is\r<br> completed (or for at least 10 days after the last dose of SAR442168, if the\r<br> case was unblinded)\r<br>\r<br> - A WOCBP must have a negative highly sensitive pregnancy test at screening and within\r<br> 24hours before the first dose of study intervention.\r<br>\r<br> - If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum\r<br> pregnancy test is required. In such cases, the participant must be excluded from\r<br> participation if the serum pregnancy result is positive.\r<br>\r<br> - The Investigator is responsible for review of medical history, menstrual history,\r<br> and recent sexual activity to decrease the risk for inclusion of a woman with an\r<br> early undetected pregnancy.\r<br>\r<br> - The participant must have given written informed consent prior to undertaking any\r<br> study related procedure. This includes consent to comply with the requirements and\r<br> restrictions listed in the informed consent form (ICF) and in this protocol. In\r<br> countries where the legal age of maturity is greater than 18 years, a specific ICF\r<br> for such legally minor participants must also be signed by the participant's legally\r<br> authorized representative\r<br>\r<br>Exclusion criteria:\r<br>\r<br> - The participant has been diagnosed with primary progressive multiple sclerosis\r<br> (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with\r<br> nonrelapsing secondary progressive multiple sclerosis (SPMS)\r<br>\r<br> - The participant has a history of infection or may be at risk for infection including\r<br> but not limited to: HIV, transplantation, live attenuated vaccines, progressive\r<br> multifocal leukoencephalopathy, tuberculosis, hepatitis B or C, any persistent\r<br> chronic or active recurring infection\r<br>\r<br> - Clinically significant laboratory abnormalities (including evidence of liver injury)\r<br> or electrocardiogram abnormalities at Screening.\r<br>\r<br> - The participant has conditions or situations that would adversely affect\r<br> participation in this study, including but not limited to:\r<br>\r<br> - A short life expectancy due to pre-existing health condition(s) as determined\r<br> by their treating neurologist\r<br>\r<br> - Medical condition(s) or concomitant disease(s) making them nonevaluable for the\r<br> primary efficacy endpoint or that would adversely affect participation in this\r<br> study, as judged by the Investigator\r<br>\r<br> - A requirement for concomitant treatment that could bias the primary evaluation\r<br>\r<br> - The participant has a history of or currently has concomitant medical or clinical\r<br> conditions that would adversely affect participation in this study\r<br>\r<br> - At screening, the participant is positive for hepatitis B surface antigen and/or\r<br> hepatitis B core antibody and/or is positive for hepatitis C antibody\r<br>\r<br> - The participant has any of the following:\r<br>\r<br> - A bleeding disorder or known platelet dysfunction at any time prior to the\r<br> screening visit\r<br>\r<br> - A platelet count <150 000/µL at the screening visit\r<br>\r<br> - The participant has a lymphocyte count below the lower limit of normal (LLN) at the\r<br> screening visit\r<br>\r<br> - The presence of psychiatric disturbance or substance abuse\r<br>\r<br> - Prior/concomitant therapy\r<br>\r<br> - The participant is receiving potent and moderate inducers of cytochrome P450 (CYP)\r<br> 3A or potent inhibitors of CYP2C8 hepatic enzymes\r<br>\r<br> - The participant is receiving anticoagulant/antiplatelet therapies\r<br>\r<br>The above information is not intended to contain all considerations relevant to a\r<br>patient's potential participation in a clinical trial.", "exclusion_criteria": null, "condition": "Relapsing Multiple Sclerosis", "intervention": "Drug: Tolebrutinib;Drug: Teriflunomide HMR1726;Drug: Placebo to match Tolebrutinib;Drug: Placebo to match Teriflunomide", "primary_outcome": "Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses", "secondary_outcome": "Time to onset of confirmed disability worsening confirmed over at least 6 months;Time to onset of CDW, assessed by the EDSS score and confirmed over at least 3 months;Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from Month 6 through the end of study (EOS);Total of Gd-enhancing T1 hyperintense lesions as detected by MRI from 6 months through the EOS;Change in cognitive function;Time to confirmed disability improvement;Percent Change in Brain volume loss (BVL);Change in Multiple Sclerosis Quality of Life;Number of participants with adverse events A(Es) leading to permanent study intervention discontinuation, and adverse events of special interest (AESI);Population Pharmacokinetics - Concentration SAR442168 and relevant metabolites at 6 months;Population Pharmacokinetics Concentration of SAR442168 and relevant metabolites at 9 Months;Population Pharmacokinetics - Concentration of SAR442168 and relevant metabolites at 12 Months;Change in plasma NfL;Change in lymphocyte Phenotype;Changes in plasma Immunoglobulin levels;Change in CHI3L1 levels", "secondary_id": "U1111-1238-1418;2020-000637-41;EFC16033", "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": 4655, "title": "MODAFIMS: A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis; Cognitive Impairment\n<br /><b>Interventions</b>: Drug: Modafinil Generis 100 mg\n<br /><b>Sponsors</b>: Clinical Academic Center (2CA-Braga)\n<br /><b>Recruiting</b>", "published_date": "2024-03-04T00:00:00Z", "discovery_date": "2024-09-27T12:57:54.079404Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06592352", "identifiers": { "nct": "NCT06592352", "euct": null, "eudract": null }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14336726", "last_refreshed_on": "2024-09-23", "scientific_title": "MODAFIMS: An Open-label, Single-center Clinical Trial to Evaluate Predictors of Response to MODAFinil in the Treatment of Cognitive Deficits in Patients With Multiple Sclerosis", "primary_sponsor": "Clinical Academic Center (2CA-Braga)", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "Yes", "inclusion_agemin": "18 Years", "inclusion_agemax": "64 Years", "inclusion_gender": "All", "date_enrollement": "2024-08-27", "target_size": "64", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 2", "countries": "Portugal", "contact_firstname": "; ;", "contact_lastname": "João Cerqueira, MD, PhD;Mónica Gonçalves;João Cerqueira, MD, PhD", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";+351 253 027 249;+351253027249", "contact_affiliation": "2CA-Braga;", "inclusion_criteria": "Inclusion Criteria:\r<br>\r<br> - Participant is willing and able to give informed consent for the participation in\r<br> the trial.\r<br>\r<br> - Patients that are able to read and write.\r<br>\r<br> - Male or female, aged between 18 and 64 years old at the time of signing the ICF.\r<br>\r<br> - Diagnosed with Relapsing-Remitting MS or Clinically Isolated Syndrome, according to\r<br> McDonald 2017 diagnostic criteria (Thompson et al., 2018).\r<br>\r<br> - Expanded disability status score (EDSS) less than 6.5.\r<br>\r<br> - Presence of subjective cognitive complaints.\r<br>\r<br> - SDMT score (number of correct responses within 90 seconds) at Screening = 55\r<br> (Benedict et al., 2016; Parmenter et al., 2007).\r<br>\r<br> - Female participants of childbearing potential and male participants whose partner is\r<br> of childbearing potential must be willing to ensure that they or their partner use\r<br> protocol's recommended effective contraception methods, which is not based only on\r<br> hormonal methods, during all the 6 months of the trial (3 months of treatment plus 3\r<br> months of safety follow-up).\r<br>\r<br> - Male participants must agree to refrain from donation of semen from first study\r<br> treatment administration up to at least 90 days after last administration.\r<br>\r<br> - Participants, that in the medical investigator's opinion, are able and willing to\r<br> comply with all trial requirements.\r<br>\r<br>Exclusion Criteria:\r<br>\r<br> - Female participant who is pregnant, breastfeeding or planning pregnancy during the\r<br> trial.\r<br>\r<br> - Participants who have participated in another research trial involving an\r<br> investigational product within the past 5 half-lives of the other investigational\r<br> product.\r<br>\r<br> - Participants who have any disability that, in the opinion of the investigator,\r<br> significantly interferes with the neuropsychological testing and/or the tasks in the\r<br> functional MRI.\r<br>\r<br> - Participants not able to undergo MRI scanning.\r<br>\r<br> - Participants who have any contra-indication for taking modafinil, according to the\r<br> prescribing information and SmPC, such as hypersensitivity to the active substance\r<br> and any excipient present in the modafinil or any documented adverse reaction after\r<br> modafinil intake.\r<br>\r<br> - Participants with known hereditary galactose intolerance, total lactase deficiency\r<br> or glucose-galactose malabsorption.\r<br>\r<br> - Participants with a history of left ventricular hypertrophy or cor pulmonale and\r<br> patients with mitral valve prolapse who developed mitral valve prolapse syndrome\r<br> when previously treated with central nervous system stimulants.\r<br>\r<br> - Current use of modafinil, armodafinil.\r<br>\r<br> - Current use of other psychostimulants, including amphetamines, cocaine, bupropion,\r<br> gingko biloba, among others, and beverages or food containing methylxanthines (e.g.,\r<br> coffee, tea, cola, caffeine, chocolate, sodas) exceeding 500 mg methylxanthines per\r<br> day (for example, consumption of more than 5 espresso coffees or 100 mg of dark\r<br> chocolate per day; Sanchez, 2017).\r<br>\r<br> - Significant neurological history aside from MS (e.g., Epilepsy).\r<br>\r<br> - Significant psychiatric history (e.g., Schizophrenia, Bipolar Disorder, Major\r<br> Depression, severe anxiety disorder, aggressive or hostile behaviour).\r<br>\r<br> - A documented history of attempted suicide in the last 2 years OR suicidal ideation\r<br> with intent, with or without a plan or method (e.g., positive response to items 4 or\r<br> 5 in the assessment of suicidal ideation on the C-SSRS) over the 6 months prior to\r<br> the Screening Visit.\r<br>\r<br> - Significant insomnia (grade > 1 according to Common Terminology Criteria for\r<br> Adverse Events, CTCAE v5)\r<br>\r<br> - History of severe hypersensitivity reactions to any medicine.\r<br>\r<br> - Presence of any clinically significant abnormality in ECG morphology or ECG\r<br> parameters.\r<br>\r<br> - Known immunodeficiency syndrome.\r<br>\r<br> - Have serum alanine aminotransferase (ALT) values greater than 3 times the upper\r<br> limit of normal at screening.\r<br>\r<br> - Positive test for anti-Human Immunodeficiency virus 1 or 2 antibodies, Hepatitis B\r<br> surface antigen (HBsAg) or anti Hepatitis C virus antibodies.\r<br>\r<br> - Creatinine clearance < 20 ml/min determined by Cockcroft-Gault equation.\r<br>\r<br> - History of alcoholism or drug abuse.\r<br>\r<br> - Average daily consumption of more than 20 cigarettes.\r<br>\r<br> - Participants with disability that interferes with the performance of the CT\r<br> procedures (for example, motor deficit in upper limb, decreased visual acuity even\r<br> with correction).\r<br>\r<br> - Participants with increased risk of epileptic seizures, history of cardiac\r<br> arrhythmias, or uncontrolled moderate to severe hypertension.\r<br>\r<br> - Participants taking warfarin or any other prohibited medication.\r<br>\r<br> - Sleep complaints confirmed by Epworth Sleepiness Scale (ESS) scale score >10 at\r<br> screening visit OR known sleep disorder.\r<br>\r<br> - Any other condition that, in the opinion of the investigator, contra-indicates the\r<br> participation of the patient.", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Cognitive Impairment", "intervention": "Drug: Modafinil Generis 100 mg", "primary_outcome": "Acute changes in brain fuction and connectivity measured using resting state fMRI.;Long-term changes in brain function and connectivity measured using resting state fMRI.", "secondary_outcome": "Acute changes in brain function and connectivity measured using a Go/no-Go task fMRI.;Long-term changes in brain function and connectivity measured using a Go/no-Go task fMRI.;SDMT score;Stroop test;MS-QoL-54 total score;WPAI:MS total score;MFIS total score;PDQ total score", "secondary_id": "2022-501414-53-00;MODAFIMS", "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": 4654, "title": "A Phase 3 Double-blind Study to Evaluate the Efficacy and Safety of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis", "summary": null, "published_date": "2024-05-24T00:00:00Z", "discovery_date": "2024-09-27T12:57:52.829487Z", "link": "https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2022-501332-42-00", "identifiers": { "ctis": "CTIS2022-501332-42-00" }, "team_categories": [], "export_date": "2024-10-04T00:00:00Z", "internal_number": "14341213", "last_refreshed_on": "2024-09-23", "scientific_title": "A Phase 3, Multicenter, Double Blind, Active-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis - IM047-050", "primary_sponsor": "Celgene International II S.a.r.l.", "retrospective_flag": "Yes", "date_registration": null, "source_register": "Clinical Trials Information System", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "0", "inclusion_agemax": "17", "inclusion_gender": "Female: yes Male: yes", "date_enrollement": null, "target_size": "60", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Number of treatment arms in the trial:", "phase": "Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No", "countries": "Taiwan;Australia;Turkey;Argentina;United States;Italy;Portugal;Spain", "contact_firstname": "GSM-CT", "contact_lastname": null, "contact_address": null, "contact_email": "[email protected]", "contact_tel": "+3223527611", "contact_affiliation": "Celgene International II S.a.r.l.", "inclusion_criteria": "Inclusion criteria: Core Phase: Diagnosis of MS with a RRMS, Core Phase: 1 MS relapse in the previous year or 2 MS relapse in past 2 years or evidence of 1 or more growth in MRI within 6 months, Core Phase: 0 - 5.5 Expanded Disability Status Scale (EDSS), Core Phase: Must be able to swallow capsule, Extension Phase: Completion of core phase", "exclusion_criteria": "Exclusion criteria: Core and Extension phase: Diagnosis of progressive form of MS, Core and Extension Phase: Active or chronic disease of the immune system, Core and Extension Phase: Any cardiovascular, liver, neurological, endocrine, or other major body disease or history or presence of malignancy, Core and Extension Phase: History of any type of epileptic seizures, substance abuse, progressive neurological disorder, or history of suicide attempt, Core and Extension Phase: Pregnant or breastfeeding females, Core and Extension Phase: Previous treatment with certain lymphocyte-depleting therapies or other immunosuppressants, Core and Extension Phase: Discontinued treatment with fingolimod or similar modulator, due to the medication not working", "condition": "Relapsing Remitting Multiple Sclerosis <br>MedDRA version: 21.1Level: PTClassification code: 10063399Term: Relapsing-remitting multiple sclerosis Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]", "intervention": "Product Name: FINGOLIMOD, Product Code:SUB31908, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: Ozanimod HCl 0.23 mg, Product Code:PRD11268182, Pharmaceutical Form: SPRINKLE CAPSULE, Other descriptive name: , Strength: , Product Name: Fingolimod 0.25 mg capsule, Fingolimod 0.5 mg capsule, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: Ozanimod HCl 0.23 mg , Ozanimod HCl 1 mg , Ozanimod HCl 0.0575 mg , Ozanimod HCl 0.25 mg, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: Ozanimod HCl 1 mg, Product Code:PRD11240872, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: Ozanimod HCl 0.0575 mg, Product Code:PRD11268147, Pharmaceutical Form: SPRINKLE CAPSULE, Other descriptive name: , Strength: , Product Name: Ozanimod HCl 0.25 mg, Product Code:PRD11240808, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: FINGOLIMOD, Product Code:SUB31908, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength:", "primary_outcome": "Main Objective: To test if ozanimod is effective compared to fingolimod (a different medication that can treat RRMS);Secondary Objective: Core phase: To determine efficacy, safety, and tolerability of ozanimod, Core phase: To measure the amount of ozanimod and certain substances in the participant’s body., Extension Phase: To determine efficacy, effectiveness, safety, and tolerability of ozanimod., Extension phase: To measure the amount of ozanimod and certain substances in the participant’s body.;Primary end point(s): Core phase: To assess rate of Multiple Sclerosis (MS) relapse over 2 years", "secondary_outcome": "Secondary end point(s):Core and Extension Phase: proportion of the participants who have worsening or improving RRMS;Secondary end point(s):Core and Extension Phase: occurrence of adverse events (type, severity and relationship to the study drug);Secondary end point(s):Core and Extension Phase: early study discontinuation;Secondary end point(s):Core and Extension Phase: measurements of the amount of ozanimod in a participant’s body", "secondary_id": "U1111-1281-5433", "source_support": "Celgene Corporation", "ethics_review_status": "Authorised", "ethics_review_approval_date": "2024-11-09", "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 } ] }