Nctid:
NCT06616194
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008881", "term"=>"Migraine Disorders"}], "ancestors"=>[{"id"=>"D051270", "term"=>"Headache Disorders, Primary"}, {"id"=>"D020773", "term"=>"Headache Disorders"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M11852", "name"=>"Migraine Disorders", "asFound"=>"Migraine", "relevance"=>"HIGH"}, {"id"=>"M9351", "name"=>"Headache", "relevance"=>"LOW"}, {"id"=>"M22529", "name"=>"Headache Disorders", "relevance"=>"LOW"}, {"id"=>"M26657", "name"=>"Headache Disorders, Primary", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-11-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-12", "completionDateStruct"=>{"date"=>"2027-12-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-12-16", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-17", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10-21", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of migraine days per month", "timeFrame"=>"12 Weeks", "description"=>"Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month"}], "secondaryOutcomes"=>[{"measure"=>"Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month", "timeFrame"=>"12 Weeks", "description"=>"Change in the use of acute migraine-specific medication days per month"}, {"measure"=>"Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month", "timeFrame"=>"12 Weeks", "description"=>"Change in headache days per month"}, {"measure"=>"Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month", "timeFrame"=>"12 weeks", "description"=>"Change in moderate or severe migraine days per month"}, {"measure"=>"Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score", "timeFrame"=>"12 Weeks", "description"=>"Change in the Quality of Life"}, {"measure"=>"Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month", "timeFrame"=>"12 Weeks", "description"=>"Change in headache and migraine rescue medication(s) used"}, {"measure"=>"Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall", "timeFrame"=>"Up to 15 months", "description"=>"Safety and tolerability of the study drug"}, {"measure"=>"Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken", "timeFrame"=>"Up to 15 Months", "description"=>"Safety monitoring of adverse events of special interest"}, {"measure"=>"Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score", "timeFrame"=>"12 Weeks", "description"=>"Change in the Quality of Life"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Chronic migraine", "adolescents", "rimegepant,"], "conditions"=>["Migraine"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://pmiform.com/clinical-trial-info-request?StudyID=C4951013", "label"=>"To obtain contact information for a study center near you, click here."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.\n\nRimegepant is a tablet that dissolves when you put it on or under your tongue.\n\nThe study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours\n\nIn the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.\n\nParticipant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.\n\nIn the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.\n\nThose who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* At least a 6 month history of migraine (with or without aura)\n* 15 or more headache days/month\n* 8 or more migraine days/month\n* Migraine lasting 4-72 hours if untreated\n\nExclusion Criteria:\n\n* Unrelenting headache\n* Current psychiatric condition uncontrolled or untreated\n* History of suicidal behavior or the subject is at risk of self-harm\n* History of alcohol abuse and/or illicit drug use\n* History of severe drug allergy\n* Use of more than one medication for migraine prevention/prophylaxis\n* Participation in another clinical trial at the same time"}, "identificationModule"=>{"nctId"=>"NCT06616194", "briefTitle"=>"A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Pfizer"}, "officialTitle"=>"AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE", "orgStudyIdInfo"=>{"id"=>"C4951013"}, "secondaryIdInfos"=>[{"id"=>"C4951013", "type"=>"OTHER", "domain"=>"Alias Study Number"}, {"id"=>"BHV3000-320", "type"=>"OTHER", "domain"=>"Alias Study Number"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Rimegepant", "description"=>"Experimental medicine under study", "interventionNames"=>["Drug: Rimegepant"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"A placebo does not have any medicine in it but looks just like the medicine being studied.", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"Rimegepant", "type"=>"DRUG", "description"=>"Rimegepant 75 mg orally disintegrating tablets", "armGroupLabels"=>["Rimegepant"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"Matching placebo oral disintegrating tablets", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"48104", "city"=>"Ann Arbor", "state"=>"Michigan", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Michigan Headache & Neurological Institute", "geoPoint"=>{"lat"=>42.27756, "lon"=>-83.74088}}, {"zip"=>"65807", "city"=>"Springfield", "state"=>"Missouri", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Clinvest Headlands Llc", "geoPoint"=>{"lat"=>37.21533, "lon"=>-93.29824}}, {"zip"=>"84107", "city"=>"Salt Lake City", "state"=>"Utah", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Wasatch Clinical Research, LLC", "geoPoint"=>{"lat"=>40.76078, "lon"=>-111.89105}}, {"zip"=>"84117", "city"=>"Salt Lake City", "state"=>"Utah", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Granger Medical Holladay - Holladay Clinic", "geoPoint"=>{"lat"=>40.76078, "lon"=>-111.89105}}, {"zip"=>"658-0064", "city"=>"Kobe", "state"=>"Hyogo", "status"=>"RECRUITING", "country"=>"Japan", "facility"=>"Konan Medical Center", "geoPoint"=>{"lat"=>34.6913, "lon"=>135.183}}, {"zip"=>"663-8204", "city"=>"Nishinomiya", "state"=>"Hyōgo", "status"=>"NOT_YET_RECRUITING", "country"=>"Japan", "facility"=>"Yamaguchi Clinic", "geoPoint"=>{"lat"=>34.71562, "lon"=>135.33199}}, {"zip"=>"556-0015", "city"=>"Osaka-Shi", "state"=>"Osaka", "status"=>"RECRUITING", "country"=>"Japan", "facility"=>"Tominaga Clinic", "geoPoint"=>{"lat"=>34.69374, "lon"=>135.50218}}, {"zip"=>"151-0051", "city"=>"Shibuya-ku", "state"=>"Tokyo", "status"=>"RECRUITING", "country"=>"Japan", "facility"=>"Tokyo Headache Clinic", "geoPoint"=>{"lat"=>35.469, "lon"=>140.29807}}, {"zip"=>"151-0051", "city"=>"Shubuya-ku", "state"=>"Tokyo", "status"=>"NOT_YET_RECRUITING", "country"=>"Japan", "facility"=>"Tokyo Headache Clinic"}, {"zip"=>"400-0124", "city"=>"Kai", "state"=>"Yamanashi", "status"=>"RECRUITING", "country"=>"Japan", "facility"=>"Nagaseki Headache Clinic", "geoPoint"=>{"lat"=>35.68463, "lon"=>138.50979}}, {"zip"=>"892-0844", "city"=>"Kagoshima", "status"=>"RECRUITING", "country"=>"Japan", "facility"=>"Tanaka Neurosurgical Clinic", "geoPoint"=>{"lat"=>31.56667, "lon"=>130.55}}, {"zip"=>"545-0053", "city"=>"Osaka", "status"=>"RECRUITING", "country"=>"Japan", "facility"=>"Tennoji Department of Neurosurgery", "geoPoint"=>{"lat"=>34.69374, "lon"=>135.50218}}], "centralContacts"=>[{"name"=>"Pfizer CT.gov Call Center", "role"=>"CONTACT", "email"=>"ClinicalTrials.gov_Inquiries@pfizer.com", "phone"=>"1-800-718-1021"}], "overallOfficials"=>[{"name"=>"Pfizer CT.gov Call Center", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Pfizer"}]}, "ipdSharingStatementModule"=>{"url"=>"https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests", "ipdSharing"=>"YES", "description"=>"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pfizer", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
