Nctid:
NCT06223074
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009103", "term"=>"Multiple Sclerosis"}, {"id"=>"D012598", "term"=>"Sclerosis"}, {"id"=>"D012008", "term"=>"Recurrence"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D020278", "term"=>"Demyelinating Autoimmune Diseases, CNS"}, {"id"=>"D020274", "term"=>"Autoimmune Diseases of the Nervous System"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D003711", "term"=>"Demyelinating Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D020969", "term"=>"Disease Attributes"}], "browseLeaves"=>[{"id"=>"M12060", "name"=>"Multiple Sclerosis", "asFound"=>"Multiple Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M15415", "name"=>"Sclerosis", "asFound"=>"Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M14850", "name"=>"Recurrence", "asFound"=>"Relapse", "relevance"=>"HIGH"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M22098", "name"=>"Demyelinating Autoimmune Diseases, CNS", "relevance"=>"LOW"}, {"id"=>"M22094", "name"=>"Autoimmune Diseases of the Nervous System", "relevance"=>"LOW"}, {"id"=>"M6909", "name"=>"Demyelinating Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D008775", "term"=>"Methylprednisolone"}, {"id"=>"D000077555", "term"=>"Methylprednisolone Acetate"}, {"id"=>"D008776", "term"=>"Methylprednisolone Hemisuccinate"}, {"id"=>"D011239", "term"=>"Prednisolone"}, {"id"=>"C009935", "term"=>"Prednisolone acetate"}, {"id"=>"C021322", "term"=>"Prednisolone hemisuccinate"}, {"id"=>"C009022", "term"=>"Prednisolone phosphate"}], "ancestors"=>[{"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000932", "term"=>"Antiemetics"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D005938", "term"=>"Glucocorticoids"}, {"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D018696", "term"=>"Neuroprotective Agents"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M11749", "name"=>"Methylprednisolone", "asFound"=>"Operative", "relevance"=>"HIGH"}, {"id"=>"M1833", "name"=>"Methylprednisolone Acetate", "asFound"=>"Operative", "relevance"=>"HIGH"}, {"id"=>"M11750", "name"=>"Methylprednisolone Hemisuccinate", "asFound"=>"Operative", "relevance"=>"HIGH"}, {"id"=>"M14120", "name"=>"Prednisolone", "asFound"=>"Operative", "relevance"=>"HIGH"}, {"id"=>"M229449", "name"=>"Prednisolone acetate", "asFound"=>"Operative", "relevance"=>"HIGH"}, {"id"=>"M211887", "name"=>"Prednisolone hemisuccinate", "asFound"=>"Operative", "relevance"=>"HIGH"}, {"id"=>"M248881", "name"=>"Prednisolone phosphate", "asFound"=>"Operative", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20773", "name"=>"Neuroprotective Agents", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "documentSection"=>{"largeDocumentModule"=>{"largeDocs"=>[{"date"=>"2024-01-08", "size"=>113457, "label"=>"Study Protocol", "hasIcf"=>false, "hasSap"=>false, "filename"=>"Prot_000.pdf", "typeAbbrev"=>"Prot", "uploadDate"=>"2024-01-08T15:49", "hasProtocol"=>true}, {"date"=>"2024-01-08", "size"=>253397, "label"=>"Informed Consent Form", "hasIcf"=>true, "hasSap"=>false, "filename"=>"ICF_001.pdf", "typeAbbrev"=>"ICF", "uploadDate"=>"2024-01-08T15:47", "hasProtocol"=>false}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"A prospective, comparative, randomized, controlled study in adult patients with confirmed Relapsing-Remitting Multiple Sclerosis that assits to the hospital with an acute relapse."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>80}}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2023-01-09", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-02-05", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-15", "studyFirstSubmitDate"=>"2023-04-25", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-11-27", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Levels of lymphocyte subsets in peripheral blood before, during, and after treatment", "timeFrame"=>"Days 0, 5 and 30 after treatment", "description"=>"•Flow cytometry will be performed using blood samples taken from patients prior to treatment, on day 5 of treatment and 30 days after treatment"}, {"measure"=>"Shannon and Chao1 indexes in feces samples to determine diversity and composition of intestinal microbiota in patients before and after treatment", "timeFrame"=>"Days 0 and 30 after treatment", "description"=>"16S rRNA will be sequenced from isolated microbial DNA obtained from patient samples to determine global microbial composition prior to treatment and 30 days after treatment"}, {"measure"=>"Number of patients with adverse effects related to the methylprednisolone intranasal treatment as assessed by a questionnaire", "timeFrame"=>"Day 30 after treatment", "description"=>"• The physician will assess possible adverse effects of the treatment using a questionnaire 30 days after treatment"}], "primaryOutcomes"=>[{"measure"=>"Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments", "timeFrame"=>"Days 0 and 30 after treatment", "description"=>"* The Expanded Disability Status Scale has a minimum score of 0, when the patient has no MS-related disability or abnormalities, and a maximum score of 10, when death is caused by MS.\n* Patients will be assessed with the EDSS prior to treatment and 30 days after the treatment ends"}], "secondaryOutcomes"=>[{"measure"=>"Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment", "timeFrame"=>"Days 0, 5 and 30 after treatment", "description"=>"Enzyme-Linked Immunosorbent Assay (ELISA) to detect inflammatory molecules will be performed in plasma derived from blood samples taken from patients prior to treatment, on day 5 of treatment and 30 days after treatment"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["methylprednisolone", "intranasal administration", "Multiple Sclerosis Relapsing Remitting"], "conditions"=>["Methylprednisolone", "Intranasal Administration", "Patients With an Active Multiple Sclerosis Relapse"]}, "descriptionModule"=>{"briefSummary"=>"This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis", "detailedDescription"=>"This is a prospective, comparative, randomized, double-blind study adhered to the principles established by the Helsinki Declaration, including informed consent. Patients with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) from the National Institute of Neurology and Neurosurgery (INNN) that are coursing with acute recurrency will be included. The recruited patients will be organized into two paired groups of 40 patients each, of which group 1 will receive 1g IV methylprednisolone, and group 2 will receive the intranasal dose equivalent to 1g of IV methylprednisolone. Clinical symptoms will be measured with the Expanded Disability Status Scale (EDSS) and data will be complemented with results of clinical tests, general laboratories and serum concentration of MP and inflammatory markers. Adverse effects in each group will also be identified and quantified. Statistical analysis: descriptive, assumption of normality, bivariate comparison of means and multivariate, in addition to intention to treat."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age between 18 and 65 years.\n* Diagnosis of RRMS with an evolution from diagnosis of 3 months to 10 years.\n* Kurtzke Expanded Disability Status Scale (EDSS) from 1 to 6 (grade 6 includes patients with unilateral aid to ambulate)\n* No contraindication for the administration of MP.\n* Agree to participate in the study by means of a signed informed consent\n\nExclusion Criteria:\n\n* Intake of anti-inflammatory steroids in the last 3 days.\n* Patients with active bacterial, viral or fungal infections or undergoing treatment.\n* Patients with hypertension.\n* Patients with diabetes mellitus.\n* Patients with hypo or hyperthyroidism.\n* Patients with glaucoma.\n* Patients with neoplasms.\n* Diagnosis of systemic diseases such as: cardiovascular, pulmonary, hepatic, endocrine, gastrointestinal, etc.\n* Patients with suspected or confirmed pregnancy by means of serum or urinary laboratory tests.\n* Breastfeeding patients.\n* Patients with a history of resistance to glucocorticoids.\n* Patients with a history of severe adverse reactions to glucocorticoids.\n* Patients with a history of hyposmia or anosmia.\n* Patients diagnosed with active sinusitis.\n* Patients with allergic rhinitis.\n* Patients with upper respiratory tract infections.\n* deviated septum\n* History of nasal surgery."}, "identificationModule"=>{"nctId"=>"NCT06223074", "acronym"=>"IN-DXM-EMRR", "briefTitle"=>"Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone Administration", "organization"=>{"class"=>"OTHER", "fullName"=>"Universidad Nacional Autonoma de Mexico"}, "officialTitle"=>"Towards the Improvement of the Treatment of Acute Relapses in Multiple Sclerosis: A Randomized Double-blind, Non-inferiority Controlled Trial Comparing Intranasal Versus Intravenous Methylprednisolone", "orgStudyIdInfo"=>{"id"=>"BD2012-34CEC"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis", "description"=>"Intravenous methylprednisolone is the standard treatment for a multiple sclerosis relapse. Thus, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intravenous methylprednisolone, 1000 mg, once a day for 3 days for moderate relapses or 5 days for severe ones.\n\nA written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent.", "interventionNames"=>["Other: IV Methylprednisolone administration"]}, {"type"=>"EXPERIMENTAL", "label"=>"Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis", "description"=>"Nasal Methylprednisolone Administration For this group, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intranasal methylprednisolone administration (1000 mg once a day for 3 days for moderate relapses or 5 days for severe ones) using a Mucosal Atomization Device (MAD Nasal).\n\nA written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent", "interventionNames"=>["Drug: Nasal Methylprednisolone (MT)"]}], "interventions"=>[{"name"=>"IV Methylprednisolone administration", "type"=>"OTHER", "otherNames"=>["ST"], "description"=>"Group 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse", "armGroupLabels"=>["Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis"]}, {"name"=>"Nasal Methylprednisolone (MT)", "type"=>"DRUG", "otherNames"=>["Nasal MT"], "description"=>"Group 2 will receive the dose intranasal equivalent to 1g of methylprednisolone for 3 or 5 days according to the severity of the relapse", "armGroupLabels"=>["Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"14269", "city"=>"Mexico City", "country"=>"Mexico", "facility"=>"Instituto Nacional de Neurología y Neurocirugía", "geoPoint"=>{"lat"=>19.42847, "lon"=>-99.12766}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "CSR"], "timeFrame"=>"Upon study completion, by request", "ipdSharing"=>"YES", "description"=>"Information exchange for research purposes"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Universidad Nacional Autonoma de Mexico", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Instituto Nacional de Neurología y Neurocirugía", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Edda Sciutto Conde", "investigatorAffiliation"=>"Universidad Nacional Autonoma de Mexico"}}}}
