[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"remitting-relapsing-multiple-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:remitting-relapsing-multiple-sclerosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100625773","cognitive-performance-sleep-disturbances-and-fatigue-in-multiple-sclerosis-100625773",false,"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,"ALL","18 Years","79 Years",{"count":21,"type":22},837,"ESTIMATED","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.",[26,27,28,29,30,31],"Multiple Sclerosis","Remitting-Relapsing Multiple Sclerosis","Primary Progressive Multiple Sclerosis","Secondary Progress Multiple Sclerosis","Fatigue Syndrome, Chronic","Sleep Disorders",[33,34,35,36],"MS","Sleep","Fatigue","Cognition","RECRUITING","2026-03-05",{"date":40,"type":41},"2026-03-06","ACTUAL",{"date":43,"type":41},"2024-11-01",{"date":45,"type":22},"2028-12",{"name":47,"class":48},"Heinrich-Heine University, Duesseldorf","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100541454","phase-2-ifenprodil-as-a-remyelinating-repurposed-drug-in-multiple-sclerosis-100541454","NCT06330077","Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis","A Phase 2 Trial Assessing Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis","MODIF-MS","Inclusion Criteria:\n\n\\-\n\nPatients:\n\n1. Signed informed consent form at pre-inclusion visit\n2. Age between 18 years and 55 years, inclusive, at time of pre-inclusion visit.\n3. Patient with a RR form of MS according McDonald criteria 2017 at pre-inclusion visit\n4. Able to comply with the study protocol and to understand the purpose and risks of the study, in the investigator's judgment\n5. Social security registration (AME excluded) at time of pre-inclusion visit\n6. At least one eye with a P100 latency \\> 118ms on visual evoked potential at baseline (defining the qualifying eye) at time of pre-inclusion visit\n7. Retinal nerve fibre layer thickness on spectral-domain optical coherence tomography \\[OCT\\] \\> 70 μm in the VEP qualifying eye (to increase the likelihood that the number of surviving axons is sufficient to provide the substrate for remyelination to occur) at time of pre-inclusion visit\n8. Patient under disease modifying therapy (first or second line approved immune active therapy) or patient without any DMT at time of pre-inclusion visit\n9. EDSS score ≤ 6 at time of pre-inclusion visit\n10. For women of childbearing potential : Efficient contraception include oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing system, sterilization method and other forms of contraception with failure rate \\\u003C1%)\n\n    * Healthy Volunteers\n\n1\\. Signed informed consent form 2. Age between 18 years and 55 years, inclusive 3. All female subjects of childbearing potential must practice effective contraception include oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing system, sterilization method and other forms of contraception with failure rate \\\u003C1%) 4. Able to comply with the study protocol, in the investigator's judgment 5. Social security registration (AME excluded)\n\nExclusion Criteria:\n\nPatients\n\n1. Patient with an acute NORB in the last 6 months prior to pre-inclusion visit\n2. Patient with a clinical relapse other than NORB in the last 6 months prior to pre-inclusion visit\n3. Patients having received methylprednisolone infusion in the last 4 weeks prior to pre-inclusion visit\n4. Contraindications to investigational medicinal products (ifenprodil\u002Fplacebo) and to auxiliary medicinal products (gadolinium, \\[18F\\]-florbetaben)\n5. Inability to complete an MRI (contraindications for MRI include but are not restricted to weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, contraindication to gadoteric acid etc.).\n6. PET imaging performed in the past 12 months as part of clinical research\n7. History or incidental discovery of significant cardiac conduction block\n8. Orthostatic hypotension Syndrome define as a drop of \\> 20 mmHg in systolic, and\u002For \\> 10 mmHg in diastolic between lying down and immediate standing\n9. Known long QT syndrome or long QT syndrome (the limit is defined at 450 ms on corrected QT) highlighted during the pre-inclusion visit\n10. Any uncontrolled general (cancer, infectious, hematologic, hepatic, immunologic, endocrinologic, neurologic, dermatologic, psychiatric, allergic, renal, or cardiovascular) disease.\n11. Creatinine clearance \\\u003C 60 ml\u002Fmin at pre-inclusion visit\n12. ASAT, ALAT of alkaline phosphatase \\> 3-fold the upper limit normal at pre-inclusion visit\n13. Know Galactosemia, glucose malabsorption or lactase deficiency\n14. Known of lack of peripheral venous access or lack of peripheral venous access highlighted during the pre-inclusion visit\n15. Thrombocytopenia with platelets \\\u003C 100 000\u002Fmm3\n16. Pregnancy and\u002For lactating women\n17. Legal protection (curatorship or tutorship)\n18. Deprive of freedom or under security measure\n19. Participation in another interventional trial evaluating a health product or any randomized trial or being in the exclusion period at the end of a previous study\n20. Refusal to be informed in case of clinically significant incidental discovery after MRI\n21. Patient treated for hypertension with the following drugs blocking the alpha-adrenergic system either in periphery (prazosine, urapidil, moxisylyte, labetalol) or centrally (clonidine, monoxidine, methyldopa)\n\nHealthy Volunteers\n\n1. Inability to complete an MRI (contraindications for MRI include but are not restricted to weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).\n2. Impossibility to complete a PET scan: pregnancy, nuclear medicine irradiation for clinical research in the year preceding baseline visit.\n3. Contraindication to auxiliary medicinal products (\\[18F\\]-florbetaben)\n4. Known presence of any neurological disorders\n5. Pregnancy and\u002For lactation\n6. Lack of peripheral venous access\n7. Terminal renal insufficiency (Creatinin clearance \\\u003C 60 ml\u002Fmin)\n8. Legal protection (curatorship or tutorship)\n9. Deprive of freedom or under security measure\n10. Participation in another interventional trial evaluating a health product or any randomized trial or being in the exclusion period at the end of a previous study\n11. Refusal to be informed in case of clinically significant incidental discovery after MRI","55 Years",{"count":59,"type":22},60,"INTERVENTIONAL",[62],"PHASE2","Multiple sclerosis (MS) is the most frequently acquired demyelinating disease and the first cause of non-traumatic chronic disability in young adults. Major progress has been achieved in the treatment of MS through the development of therapies targeting the adaptative immune system, which drastically reduce the relapse rate, with various efficiency and safety profiles (Ontaneda, 2015). However, these drugs generally fail to prevent disability worsening along the disease course, and we are now assisting to a shift in therapeutic objectives from the development of new immune drugs towards the identification of therapeutic strategies that could prevent neurodegeneration by promoting myelin regeneration (Stangel, 2017; Stankoff, 2016), in order to prevent neurological disability in MS (Irvine and Blakemore, 2008; Patrikios, 2006; Duncan I, 2017, Bodini, 2016).\n\nAmong the first candidate compounds developed to promote remyelination was the anti Lingo1 antibody, which enhance remyelination (Mi, 2009). Medium and large throughput screening of drug libraries subsequently identified several chemical classes of compounds with strong promyelinating properties, such as the antifongic drug miconazole (Najm, 2015) or the muscarinic antagonist clemastine (Wei, 2014). A recent innovative trial has investigated the effect of clemastine, compared to placebo, in a small sample of subjects (25 patients per group) and showed that clemastine could significantly improve the optic nerve conduction speed which reflecting myelin integrity and functionality (Green, 2017).\n\nOur preclinical research has allowed us to identify ifenprodil as a powerful drug to promote myelin repair in vitro and in vivo across species. In parallel our team recently pioneered and optimized a PET imaging approach for quantifying remyelination in the whole brain, that allowed to enhance the sensitivity to detect the myelin repair process, and showed that patients are characterized by heterogeneous profiles of spontaneous remyelination profiles that are closely linked to disability accrual (Bodini, 2016).",[26,65],"Remitting Relapsing Multiple Sclerosis",[26,67,68,69,70],"Ifenprofil","Combination of magnetic resonance imaging (MRI) and positron emission tomography (PET)","18f-Florbetaben","Remyelination","NOT_YET_RECRUITING","2024-03-18",{"date":74,"type":41},"2024-03-26",{"date":76,"type":22},"2024-03",{"date":78,"type":22},"2027-06",{"name":80,"class":48},"Assistance Publique - Hôpitaux de Paris"]