[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643801":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":30,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":30,"id":56,"slug":30,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":30,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":30,"overallStatus":40,"whyStopped":30,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Kriya Therapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants receiving RP-008","EXPERIMENTAL","Participants will receive a single dose of RP-008 on Day 1 at varying dose levels according to the dose escalation study design. In addition, varenicline tartrate and oral corticosteroid (equivalent to prednisone or prednisolone) will be administered during the pre- and post-treatment follow-up periods.",[13,14],"Genetic: RP-008","Drug: Varenicline tartrate",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"GENETIC","RP-008","RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion.",[9],[22],"KRIYA-748",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Varenicline tartrate","Varenicline tartrate will be administered as a daily oral tablet.",[9],[29],"Champix",null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"VP Medical Affairs","CONTACT","984-884-5058","clinicaltrials@kriyatx.com",[38],{"facility":39,"status":40,"city":41,"state":30,"zip":30,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Kriya Clinical Study Site","RECRUITING","Sherbrooke","Canada",{"type":44,"coordinates":45},"Point",[46,47],-71.89908,45.40008,{"lat":47,"lon":46},[50],{"name":51,"role":34,"phone":52,"phoneExt":30,"email":53},"Clinical Projects Coordinator","+1 819-346-1110","chus@ssss.gouv.qc.ca",{"type":55,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100643801",false,"NCT07596485","RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia","A Phase 1\u002F2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, and PRELIminary EFficacy of Percutaneous Injection of RP-008 Followed by Daily Oral Varenicline in Patients With Trigeminal Neuralgia (The RELIEF Study)","RELIEF","Inclusion Criteria:\n\n* Participant is capable of providing signed informed consent.\n* Participant must be between 18 to 80 years of age (inclusive), at the time of signing the informed consent.\n* Confirmed diagnosis of classical or idiopathic TN according to the criteria of the International Classification of Headache Disorders-3rd edition (ICHD-3, 2018).\n* The diagnosis of TN established at least 6 months prior to Screening.\n* Participant has purely unilateral pain attacks limited primarily to the maxillary (V2) and\u002For mandibular (V3) division of the trigeminal nerve.\n* Participant has failed at least 1 standard of care anti-epileptic agent (e.g., carbamazepine, oxcarbazepine, pregabalin, gabapentin, phenytoin, lamotrigine). Failure to a prior anti-epileptic medication is defined as insufficient pain relief despite use of a therapeutic dose for an adequate duration of time or being unsuitable due to contraindications or intolerance to side effects.\n* Participant is on stable dosage of any TN anti-epileptic agent(s) for a minimum of 6 weeks prior to Screening.\n\nExclusion Criteria:\n\n* Participant has bilateral TN pain attacks.\n* Participants with secondary TN, defined by ICHD-3 as TN caused by an underlying disease (e.g., tumor in the cerebellopontine angle, arteriovenous malformation, or multiple sclerosis).\n* Participants with facial pain not meeting the ICHD-3 diagnostic criteria for either classical or idiopathic TN, including: trigeminal autonomic cephalalgias, cluster headache, hemicrania continua, paroxysmal hemicrania, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA).\n* Participants who had no change in pain after taking sodium channel blockers despite the use of a therapeutic dose for an adequate duration of time.","ALL","18 Years","80 Years",{"count":67,"type":68},24,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","The goal of this study is to evaluate if KRIYA-748 (RP-008) is safe, tolerable, and preliminary effective in treating trigeminal neuralgia (TN) when used in combination with varenicline tartrate. The study will also assess what doses of RP-008 are safe and tolerable for participants and how the severity of participants' TN pain and frequency of facial pain attacks are affected.",[75],"Trigeminal Neuralgia","2026-06-04",{"date":78,"type":79},"2026-06-08","ACTUAL",{"date":81,"type":68},"2026-08",{"date":83,"type":68},"2029-02",{"name":5,"class":6},1]