[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532751":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":67,"collaborators":41,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":41,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":41,"enrollmentInfo":78,"targetDuration":41,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OnabotulinumtoxinA","EXPERIMENTAL","Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.",[13],"Drug: OnabotulinumtoxinA 100 UNT [Botox]",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline","PLACEBO_COMPARATOR","The same procedure will be followed as above, but saline will be injected instead of onabotA",[19],"Drug: Sodium Chloride 0.9% for Injection, Preservative Free",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","OnabotulinumtoxinA 100 UNT [Botox]","Intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1\u002FV2 were affected, the patient would get 50 units of onabotA. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.",[9],[27],"Botox",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sodium Chloride 0.9% for Injection, Preservative Free","intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1\u002FV2 were affected, the patient would get 50 units of saline. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.",[15],[15],[34],{"name":35,"affiliation":5,"role":36},"Meredith Barad, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","6507217218",null,"nlariyos@stanford.edu",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":42},"Natali Ariyoshi","6504978821",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Meredith Barad","RECRUITING","Stanford","California","94304","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-122.16608,37.42411,{"lat":59,"lon":58},[62,66],{"name":63,"role":39,"phone":64,"phoneExt":41,"email":65},"Meredith Study Team","650-721-7218","mbarad@stanford.edu",{"name":35,"role":36,"phone":41,"phoneExt":41,"email":41},{"type":36,"investigatorFullName":48,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Clinical Associate Professor of Anesthesiology (Pain) and Neurology & Neurological Sciences","100532751","phase-4-onabotulinumtoxina-for-trigeminal-neuralgia-100532751",false,"NCT06216886","OnabotulinumtoxinA for Trigeminal Neuralgia","Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.","Inclusion Criteria:\n\nMen and women age 18 or older\n\n* Judged to be of legal competence\n* Sufficient knowledge of written and spoken English\n* Capable of attending regular in-person visits\n* Have failed\u002Fnot a candidate\u002Fdo not want surgery\n* Inadequate response to medication - at least 2 trials\n* Meeting ICHD criteria for Classical Trigeminal Neuralgia 13.1.1.1\n* Patients with frequency \\> 10 attacks per week\n* Stable dose of medications in the last 2 weeks\n\nExclusion Criteria:\n\n* Secondary or Idiopathic TN, or Painful Trigeminal Neuropathy as defined by the ICHD (13.1.1.2, 13.1.1.3, 13.1.2)\n* Pregnant or breast feeding (while it is rare that a patient will be pregnant with TN, there is not sufficient data to say definitively that onabotA is ok to use during pregnancy and nursing, it is still rated Class C)\n* Neuromuscular disease\n* On aminoglyocosides\n* Not currently enrolled in any other studies","ALL","18 Years",{"count":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.",[86],"Trigeminal Neuralgia",[88,89,90],"botox","injection","trigeminal neuralgia","2026-01-20",{"date":93,"type":94},"2026-01-22","ACTUAL",{"date":96,"type":94},"2024-06-01",{"date":98,"type":80},"2027-09-01",{"name":5,"class":6},1]