[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-progressive-multiple-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-progressive-multiple-sclerosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,82,114,145,169],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100630113","phase-4-a-study-to-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-ocrelizumab-in-participants-with-relapsing-multiple-sclerosis-and-primary-progressive-multiple-sclerosis-100630113",false,"NCT07483450","A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis","A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* Diagnosis of RMS\u002FPPMS in accordance with the revised 2017 McDonald Criteria\n* EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline\n* Documented MRI of brain with abnormalities consistent with MS before screening\n\nExclusion Criteria:\n\n* Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)\n* History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)\n* Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)\n* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n* Inability to complete an MRI scan or contraindication to Gd administration\n* Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)\n* Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and\u002For safety during the study\n* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* Known history of human immunodeficiency virus (HIV) infection\n* Lack of peripheral venous access\n* Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening\n* Positive screening tests for hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV)","ALL","18 Years","55 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with primary progressive multiple sclerosis (PPMS).",[27,28],"Relapsing Multiple Sclerosis","Primary Progressive Multiple Sclerosis","RECRUITING","2026-05-22",{"date":32,"type":33},"2026-05-27","ACTUAL",{"date":35,"type":33},"2025-07-04",{"date":37,"type":21},"2027-04-23",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",17,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100629666","phase-1-treatment-of-participants-with-primary-or-secondary-progressive-multiple-sclerosis-100629666","NCT07477639","Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis","A Phase 1\u002F2a, Open-Label, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX319 in Subjects With Primary or Secondary Progressive Multiple Sclerosis","IMPACT-MS","Inclusion Criteria:\n\n1. Clinical diagnosis of MS with evidence of PPMS or SPMS according to 2025 McDonald criteria.\n2. Expanded Disability Status Scale (EDSS) range ≥ 2.5 to ≤ 6.5.\n3. Evidence of clinical disability progression within 2 years prior to enrollment.\n4. Documented presence of CSF-restricted OCBs and\u002For elevated IgG index and\u002For κ free light chain.\n5. Males and females ≥ 18 and ≤ 65 years of age at time of consent.\n6. Evidence of adequate organ function\n7. Women of child bearing potential have a negative pregnancy test at screening.\n8. Contraceptive use by all participants while on study.\n9. Participants must be able to understand, consent, and be willing and able to complete all specified procedures and visits.\n10. Positive varicella zoster virus titer. Participants who test seronegative for varicella zoster virus IgG antibodies need to complete vaccination ≥ 4 weeks prior to TRX319 infusion.\n11. Participants must be willing to refrain from donating blood for 1 year after TRX319 infusion.\n\nExclusion Criteria:\n\n1. MS clinical stability on disease modifying therapy.\n2. Clinical relapse of MS in the 1 year prior to study entry.\n3. Diseases other than MS to explain the first demyelinating event, including aquaporin 4 IgG or myelin oligodendrocyte glycoprotein-IgG seropositivity.\n4. Prior treatment with CAR-T or gene therapy product directed at any target.\n5. Prior treatment with mitoxantrone, cladribine (or other chemotherapies), or alemtuzumab within 2 years prior to TRX319 dose.\n6. Prior treatment with CD20-depleting antibodies within 3 months and prior treatment with Bruton's tyrosine kinase inhibitor (BTKi) and sphingosine 1 phosphate (S1P) modulators within 1 month of TRX319 dose.\n7. Plan to or have received live, attenuated vaccines less than 4 weeks (28 days) prior to TRX319 infusion, and other vaccines less than 2 weeks (14 days) prior to TRX319 infusion.\n8. Serologic status reflecting active hepatitis B or C infection.\n9. Positive serology for human immunodeficiency virus (HIV).\n10. History of progressive multifocal leukoencephalopathy.\n11. Untreated active, or active with documented completed treatment but without a negative chest X-ray that shows no evidence of active tuberculosis, or latent tuberculosis.\n12. Primary immunodeficiency as defined by a known genetic disorder.\n13. History of splenectomy.\n14. Impaired cardiac function or clinically significant cardiac disease.\n15. Previous or concurrent malignancy.\n16. Prior organ transplant, or allogeneic hematopoietic stem cell transplantation or recipient of peripheral blood products \\\u003C 3 years prior to TRX319 infusion.\n17. Major surgery within 4 weeks prior or planned within 4 weeks after TRX319 administration.\n18. History of any other neurologic disorder or medical condition the Investigator considers would increase the risk for the participant, including seizure disorders.\n19. Life-threatening allergies, hypersensitivity, or documented intolerance to TRX319 drug product excipients.\n20. Subjects that are pregnant, breast feeding or aim to become pregnant during the study period (Subjects must agree to use a highly effective method of contraception).\n21. Serious and\u002For uncontrolled medical condition that, in the Investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol.","65 Years",{"count":52,"type":21},39,[54,55],"PHASE1","PHASE2","The goal of this clinical trial is to treat male and female participants with two types of Multiple Sclerosis (MS) called primary progressive or secondary progressive MS.\n\nThe main questions the trial aims to answer are the following:\n\n* Is TRX319 safe when administered to patients with progressive forms of MS?\n* At what dose does TRX319 work the best to treat participants with primary and or secondary progressive MS?\n* Is pre-conditioning (with Bendamustine) needed to allow TRX319 to better treat participants with primary and\u002For secondary progressive MS?\n\nParticipants will be asked to be on study for up 1 year and may receive up to 3 total administrations of TRX319. While on study, participants will have blood tests and other assessments (MRI scans and lumbar punctures) done to understand the safety of TRX319 and how it may benefit their multiple sclerosis.",[28,58,59,60,61],"Secondary Progressive Multiple Sclerosis (SPMS)","Multiple Sclerosis","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive",[63,48,64,59,65,66,67,68,69,70,71],"TRX319-01","Tr1X","MS","Autoimmune","Impact MS","PPMS","SPMS","Primary Progressive","Secondary Progressive","2026-03-17",{"date":74,"type":33},"2026-03-19",{"date":76,"type":21},"2026-03",{"date":78,"type":21},"2029-01",{"name":80,"class":40},"Tr1X, Inc.",2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":81},"100625773","cognitive-performance-sleep-disturbances-and-fatigue-in-multiple-sclerosis-100625773","NCT07426991","Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis","The Effects of Sleep Disturbances on Fatigue and Cognition in Multiple Sclerosis","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 79 years (all groups)\n* Adequate (corrected) hearing and vision to complete neuropsychological testing (all groups)\n* Sufficient proficiency in German to participate in assessments (all groups)\n* Capacity to provide informed consent and understanding of study procedures (all groups)\n* Diagnosis of MS according to the 2017 revised McDonald criteria (MS group)\n* Indication for sleep medicine evaluation due to at least mild fatigue, operationalized as ≥ 43 points on the Fatigue Scale for Motor and Cognitive Functions (FSMC) (MS group)\n* Indication for sleep medicine evaluation (control group)\n\nExclusion Criteria:\n\n* Lack of signed informed consent or inability to provide consent (all groups)\n* Age \\\u003C 18 years or \\> 79 years (all groups)\n* Presence of another neurological disorder in addition to MS, with the exception of migraine (all groups)\n* Use of medications that influence polysomnographic parameters (e.g., benzodiazepines) (all groups)\n* Uncorrected hearing or vision impairment and\u002For insufficient German language proficiency likely to impact neuropsychological test results (all groups)",true,"79 Years",{"count":92,"type":21},837,"OBSERVATIONAL","Fatigue is a prevalent symptom in patients with multiple sclerosis (MS) and is associated with considerable impairment in quality of life as well as loss of occupational capacity. Sleep disturbances are regarded as a critical factor in the development of fatigue and are frequently observed in individuals with MS. However, they often remain underrecognized, undiagnosed, and consequently untreated.\n\nPolysomnography, the gold standard for assessing sleep architecture and quality, has rarely been applied in the investigation of sleep disorders in MS. Accordingly, uncertainties remain regarding the prevalence and extent to which sleep disturbances contribute to fatigue in this population. Moreover, emerging evidence suggests an association between sleep disorders and cognitive dysfunction in MS. Yet, it is unclear whether cognitive impairment arises from the sleep disorder itself, from the resulting fatigue, or from other independent factors.\n\nPharmacological treatments for MS-related fatigue remain limited, given heterogeneous and frequently non-replicable effects. Non-pharmacological interventions such as physical activity, cognitive behavioral therapy, and psychoeducation have shown promise but yield variable outcomes. The development of novel and effective therapeutic strategies requires a more comprehensive understanding of the etiology of fatigue. To date, the role of sleep disturbances and their relationship to cognitive performance in MS have not been adequately investigated.\n\nThe objective of this project is to determine the prevalence and characteristics of sleep disorders in MS patients with fatigue using polysomnography and to examine their relationship with cognitive impairment. In addition, the study will compare sleep quality parameters and the prevalence of sleep disorders across different MS subtypes (relapsing-remitting, primary progressive, and secondary progressive). Furthermore, within a sub-study, it will be investigated whether the type of immunotherapy has an influence on the aforementioned aspects.\n\nFinally, the project seeks to integrate artificial intelligence (AI) into polysomnography analysis to streamline data evaluation and facilitate the future assessment of therapeutic interventions.\n\nThe study will be conducted as a non-invasive, non-interventional, longitudinal observational trial including MS patients with fatigue and a control group of patients with subjective sleep complaints but without MS. Recruitment will take place over 36 months at two centers: the Department of Neurology at the University Hospital Düsseldorf and the Maria Hilf Clinics in Mönchengladbach. Additional recruitment will be supported by community-based neurologists in the Mönchengladbach region to broaden the study cohort and ensure representativeness of the study population.\n\nApproximately 382 MS patients are expected to be enrolled. The number of control participants will be determined by the proportion of MS patients presenting with sleep disorders and will be recruited consecutively from the neurological sleep laboratory of the Maria Hilf Clinics. For AI training, retrospective polysomnography data from the past five years (N ≥ 10,000 patients) at the Maria Hilf Clinics will be utilized.\n\nThe study protocol includes overnight polysomnography to assess sleep quality, along with comprehensive clinical evaluation, neuropsychological testing, and validated questionnaires addressing fatigue, subjective sleep quality, daytime sleepiness, depression, and anxiety.\n\nBased on manually scored polysomnography, AI models will be trained to identify key parameters of sleep quality. The findings of this study will advance the understanding of the role of sleep disturbances in MS-related fatigue and will facilitate the integration of AI into sleep research, thereby streamlining the evaluation of future therapeutic approaches.",[59,96,28,97,98,99],"Remitting-Relapsing Multiple Sclerosis","Secondary Progress Multiple Sclerosis","Fatigue Syndrome, Chronic","Sleep Disorders",[65,101,102,103],"Sleep","Fatigue","Cognition","2026-03-05",{"date":106,"type":33},"2026-03-06",{"date":108,"type":33},"2024-11-01",{"date":110,"type":21},"2028-12",{"name":112,"class":113},"Heinrich-Heine University, Duesseldorf","OTHER",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":144},"100614536","clinnova-ms-a-prospective-cohort-study-of-patients-with-multiple-sclerosis-a-trans-regional-digital-health-effort-unlocking-the-potential-of-artificial-intelligence-and-data-science-in-health-care-100614536","NCT07280871","Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care","Clinnova-MS","Inclusion Criteria:\n\n1. Signed informed consent form\n2. ≥ 18 years of age\n3. Willing and able to comply with the protocol for the duration of the study including data and samples collection as well as study visits and examinations.\n4. Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (\\\u003C 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.\n\nExclusion Criteria:\n\n1. Diagnosis uncertain (no fulfilment of inclusion criteria)\n2. Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits such as mental disability that makes it difficult or impossible to answer questionnaires.\n3. Not fluent in any of the following languages: French, English or German.\n4. Known pregnancy before the inclusion into the study",{"count":122,"type":21},100,"The Clinnova-Multiple Sclerosis (MS) study is part of the Clinnova program (NCT06526364; NCT06235684 and NCT05733702), which seeks to advance precision medicine and the digitalization of healthcare through high-quality, interoperable health data.\n\nThis program focuses on people with multiple sclerosis (MS) and aims to identify objective surrogate markers derived from clinical, epidemiological, imaging, and omics data that can predict disease activity, such as progression or relapses.\n\nBy combining data science and artificial intelligence, the project seeks to improve patient stratification, support personalized therapeutic decisions, and provide insights into the mechanisms underlying treatment response and disease progression.\n\nAlthough many therapies are available for MS, it remains challenging to determine the most appropriate strategy for each patient and to prevent long-term disability. Current treatments mainly target relapses and inflammation, with limited effects on chronic progression. Clinnova-MS will collect and analyze real-world and research data to better understand variability in disease activity and treatment outcomes, enabling more precise, evidence-based care within the standard of care. This study represents the first step toward the broader Clinnova objective: developing sustainable, personalized, and preventive healthcare for people living with MS.",[125,126,127,28],"Multiple Sclerosis, Relapsing-Remitting","Multiple Sclerosis, Chronic Progressive","Clinically Isolated Syndrome",[129,130,65,131,132],"AI","Machine Learning","phenotyping","personalised medicine","NOT_YET_RECRUITING","2025-12-31",{"date":136,"type":33},"2026-01-06",{"date":138,"type":21},"2026-06",{"date":140,"type":21},"2040-06",{"name":142,"class":143},"Luxembourg Institute of Health","OTHER_GOV",1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":144},"100345876","phase-1-sizomus-safety-of-ixazomib-targeting-plasma-cells-in-multiple-sclerosis-100345876","NCT03783416","SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis","Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis: A Phase 1b Randomised, Double-blind, Placebo-controlled Trial.","SIZOMUS","Inclusion Criteria:\n\n\\- Each participant must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Male and female patients 18 to 65 years old at screening\n2. Must have a diagnosis of MS, and:\n\n   * Patients with RRMS must be on DMT\n   * Patients with progressive MS must not be on DMT\n3. Participants with RRMS must be on stable DMT (i.e. must not have had a relapse within 1 month prior to the screening visit). Patients on tecfidera, cladribine, ocrelizumab, alemtuzumab, fingolimod or natalizumab must be enrolled with caution, at Chief Investigator's (CI) discretion because of the lymphopenia caused by these drugs and the risk of thrombocytopenia in 1-2 % of people after alemtuzumab\n4. OCB positive CSF either from a previous CSF analysis or from the screening CSF analysis\n5. Able and willing to give written informed consent and comply with protocol requirements with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n6. Agree to the use of effective contraception as follows:\n\n   Female patients must:\n   * Be postmenopausal for at least 1 year before the screening visit (postmenopausal status confirmed by serum Follicle Stimulating Hormone (FSH) and oestrogen levels at screening or from a historical sample), OR\n   * Surgically sterile, OR\n   * If they are of childbearing potential, must agree to practice two effective methods of contraception concurrently from the time of signing the informed consent form until 90 days after the last dose of study drug, OR\n   * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception\n\n   Male patients must:\n   * Even if surgically sterilized (post-vasectomy with documentation of azoospermia), agree to practice effective barrier contraception during the entire study treatment period and through to 90 days after the last dose of study drug, OR\n   * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception\n7. Clinical laboratory values:\n\n   1. Absolute neutrophil count (ANC) ≥ 1 x 109\u002FL\n   2. Platelet count ≥ 100 x 109\u002FL\n   3. Total bilirubin ≤ 1.5 × the upper limit of the normal range (ULN)\n   4. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 3 × ULN.\n   5. Calculated creatinine clearance ≥ 30 mL\u002Fmin\n\nExclusion Criteria:\n\n* Participants meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n  1. EDSS \\> 8.5 at screening\n  2. MS relapse within 1 month prior to screening\n  3. Female patients who are lactating or have a positive serum pregnancy test at screening\n  4. Major surgery within 14 days before baseline\n  5. Any clinically relevant malignancy or infection, as per CI\u002FPI (or delegate) decision, including a possible diagnosis of multiple myeloma: raised erythrocyte sedimentation rate (ESR) and positive urine Bence Jones protein at screening\n  6. Infection requiring systemic (intravenous) antibiotic therapy or other serious infection within 14 days before study enrolment. Urinary tract infections (UTIs) will be treated prior to baseline and may delay baseline\n  7. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6 months of screening\n  8. Systemic treatment, within 14 days before the first dose of ixazomib, with strong Cytochrome P450 Isoform 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's Wort\n  9. History of active hepatitis B or C virus infection, or human immunodeficiency virus (HIV) positive or positive Tuberculin (TB) ELISPOT. If there is positive TB ELISPOT and the TB team decides to treat as latent TB, participants can be reassessed for inclusion after treatment\n  10. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n  11. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing\n  12. Diagnosed or treated for malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection\n  13. Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period\n  14. Participation in other clinical trials involving investigational (unlicensed) medicinal products, licensed medicinal products or alternative medicinal therapies, within 30 days of screening and throughout the duration of this trial. Participation in non-interventional, questionnaire or observational studies whilst enrolled in this study is permitted.\n  15. Patients that have previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or placebo\n  16. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent\n  17. Any pre-existing central nervous system disease or involvement other than MS\n  18. History of uncontrolled drug or alcohol abuse within 6 months prior to screening.",{"count":154,"type":21},72,[54],"The study seeks to investigate safety and efficacy of ixazomib (NINLARO), a proteasome inhibitor, in multiple sclerosis (MS). Participants will receive either ixazomib capsules or placebo capsules for up to 24 months.",[158,28,159],"Relapsing Remitting Multiple Sclerosis","Secondary Progressive Multiple Sclerosis","2025-09-01",{"date":162,"type":33},"2025-09-04",{"date":164,"type":33},"2020-06-15",{"date":166,"type":21},"2026-07-31",{"name":168,"class":113},"Queen Mary University of London",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100585271","phase-1-a-study-of-allogeneic-hematopoietic-cell-transplantation-for-primary-progressive-multiple-sclerosis-100585271","NCT06900192","A Study of Allogeneic Hematopoietic Cell Transplantation for Primary Progressive Multiple Sclerosis","A Multicenter Phase 1 Study of Allogeneic Hematopoietic Cell Transplantation for Primary Progressive Multiple Sclerosis Using Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood","Inclusion Criteria (Recipient):\n\n1. Participants aged ≥18 and ≤65 years with primary progressive multiple sclerosis\n2. A diagnosis of PPMS by 2017 McDonald criteria and 2013 clinical course revision102\n3. CSF with elevated IgG index or 2 or more oligoclonal bands\n4. EDSS (see Appendix 9) between 2.0 and 5.5 inclusive\n5. Based on review of the clinical records, there must be a deterioration in the EDSS of at least 1 or more points over the previous 4 years (or less).\n6. Eligibility criteria confirmed by the Eligibility Review Group (Appendix 10)\n7. Recipients who have been treated with ocrelizumab, rituximab, ofatumumab, ublituximab, or alemtuzumab must undergo a washout period as described in Appendix 14 prior to their planned day 0.\n8. Recipients must be willing to undergo mobilized autologous peripheral blood stem cell collection to create a cryopreserved rescue product prior to alloHCT.\n9. Ability to undergo MRI without general anesthesia\n10. Ability to undergo all tests and procedures in the study\n11. Patients who are not vaccinated for COVID-19 must have no symptoms of COVID-19 and have negative testing for COVID-19. For other vaccine-preventable illnesses, it is recommended that patients are current on their vaccination schedule.\n\nExclusion Criteria:\n\n1. History of Progressive Multifocal Leukoencephalopathy\n2. Organ dysfunction or disease that would jeopardize survival after hematopoietic cell transplantation, including but not limited to the following:\n\n   1. Renal insufficiency as defined by an estimated GFR \\\u003C60 mL\u002Fminute\n   2. Cardiac dysfunction as defined by symptomatic coronary artery disease, congestive heart failure, valvular heart disease, cardiomyopathy, uncontrolled arrhythmia(s), or left ventricular ejection fraction \\\u003C50%. Participants with a history of these conditions may enroll if they are demonstrated to have optimal cardiac function (as defined by echocardiography or multi-gated acquisition scan)\n   3. Pulmonary dysfunction that poses a risk of mortality after transplant, defined as pre-transplant pulmonary function testing demonstrating a FEV1 \\\u003C70% expected and\u002For a DLCOadj \\\u003C70% expected.\n   4. Necroinflammatory or fibrotic liver disease with evidence of liver dysfunction, including but not limited to jaundice, hepatic encephalopathy, or portal hypertension\n   5. Marrow dysfunction that poses a risk of peri-transplant mortality, defined as an absolute neutrophil count (\\\u003C1000\u002Fmm3) below the lower limit of normal, or a platelet count below 50,000\u002Fmm3.\n   6. Poorly controlled hypertension despite appropriate therapy, defined as a diastolic blood pressure greater than 90 mm Hg while on therapy.\n   7. Poorly controlled diabetes mellitus, defined as HgbA1c ≥ 6.5% despite therapy or recurrent hypoglycemia while on therapy.\n   8. Extreme protein-calorie malnutrition defined by Body Mass Index \\\u003C18 and unintentional weight loss (3 kg in the last month or 6 kg in the last 6 months.)\n3. History of smoking either tobacco or other herbal products in the last 3 months.\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion (TCD), eg, cladribine, or peritransplant antithymocyte globulin (ATG). For participants who have previously been exposed to a TCD agent, a 5-half-life washout of the agent must occur prior to planned day 0 (day 0 is defined as the day of infusion Orca-Q Prime). The washout period for alemtuzumab is listed in Appendix 14.\n5. HIV seropositive.\n6. HBV serology results indicating chronic HBV infection per https:\u002F\u002Fwww.cdc.gov\u002Fhepatitis\u002Fhbv\u002FinterpretationOfHepBSerologicResults.htm, unless HBV PCR negative. HBV seropositive participants should be on antiviral therapy after transplant.\n7. HCV seropositive, unless PCR negative and having undergone 'curative' antiviral therapy.\n8. Participant has active uncontrolled infection\n9. Participant has demonstrated lack of compliance with prior medical care\n10. Participants with known active malignancy. It is recommended that patients are current on cancer screening tests for their age and family history as per the NCCN \\[The National Comprehensive Cancer Network®\\] Guidelines. Screening should be performed, if indicated, per NCCN guidelines prior to study treatment.\n11. Participants whose life expectancy is severely limited by illness other than multiple sclerosis\n12. Females who are pregnant or breast feeding.\n13. Medical or psychiatric conditions that compromise ability to give informed consent or to comply with treatment protocol\n14. Inability to undergo an MRI scan\n15. Currently receiving treatment with investigational agents\n16. Positive for JC virus DNA in the CSF or blood during screening.",{"count":177,"type":21},10,[54],"A study of alloHCT with Orca-Q for the treatment of primary progressive multiple sclerosis (MS).",[28,59,181,182],"Multiple Sclerosis, Primary Progressive","Multiple Sclerosis, Secondary Progressive","2025-03-26",{"date":185,"type":33},"2025-03-28",{"date":187,"type":21},"2025-03",{"date":189,"type":21},"2029-08",{"name":191,"class":113},"Stanford University"]