[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-migraine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-migraine":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100412337","phase-3-randomized-study-in-children-and-adolescents-with-migraine-acute-treatment-100412337",false,"NCT04649242","Randomized Study in Children and Adolescents With Migraine: Acute Treatment","Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to \u003C 18 Years of Age","Inclusion Criteria:\n\n1. History of migraine (with or without aura) for \\> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and\u002For participant's parent(s)\u002Flegal representative(s).\n2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \\> 3 hours without treatment, and attacks occurring at intervals \\> 24 hours.\n3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.\n\n   1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \\[biologic or small molecule\\], during the treatment phases.\n   2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.\n   3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.\n4. Verbally distinguish between migraine and other types of headaches.\n5. Participants must have a weight \\> 40 kg at the Screening Visit.\n6. Adequate venous access for blood sampling.\n7. Male and female participants ≥ 6 to \\\u003C 18 years of age (participants must not reach their 18th birthday during the study).\n\nExclusion Criteria:\n\n1. History of cluster headache or hemiplegic migraine headache.\n2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.\n3. Current psychiatric condition that is uncontrolled and\u002For untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and\u002For mania.\n4. History of suicidal behavior or major psychiatric disorder.\n5. Current diagnosis or history of substance abuse; positive drug test at Screening.\n6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.\n7. Recent or planned surgery, requiring general anesthesia, \\\u003C8 weeks prior to the Screening Visit.\n8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).\n9. Current diagnosis of viral hepatitis or a history of liver disease.\n10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy","ALL","6 Years","17 Years",{"count":20,"type":21},2100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.",[27],"Pediatric Migraine",[29,30,31,32,33,34,35,36,27],"Migraine","Acute treatment","Phonophobia","Photophobia","Nausea","Pediatric","Children","Adolescent","RECRUITING","2026-06-29",{"date":40,"type":41},"2026-07-01","ACTUAL",{"date":43,"type":41},"2021-01-15",{"date":45,"type":21},"2029-01-09",{"name":47,"class":48},"Pfizer","INDUSTRY",246,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100625205","migrafit-evaluating-a-group-therapy-program-combining-physical-activity-progressive-muscle-relaxation-and-psychoeducation-for-adolescents-with-migraine-100625205","NCT07419607","MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine","MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine - Study Protocol for a Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed migraine as defined by ICHD-3 (International Classification of Headache Disorders, 3rd edition)\n* Age: 13-17 years\n* Place of residence within a 35-kilometer radius of the study site, except for children who live outside of this radius but commute close to the study site daily due to school or work attendance\n\nExclusion Criteria:\n\n* Intake of continuous prophylactic medication for migraine\n* Any change in migraine medication within the past 4 weeks\n* Psychiatric or somatic comorbidities which could interfere with participation in a weekly group therapy that includes physical activity","13 Years",{"count":59,"type":21},30,[61],"NA","Background: Migraine is a headache disorder highly prevalent in children and adolescents. It significantly affects academic performance and quality of life. A conservative approach to pharmacological prophylaxis for pediatric patients persists in clinical practice, as potential risks must be carefully weighed against the benefits for each individual patient. Non-pharmacological interventions, including physical activity, progressive muscle relaxation (PMR) and psychoeducation have shown promising effects individually but demand a high level of patient motivation. This study protocol creates the foundation to evaluate a novel group therapy program combining high-intensity interval training (HIIT), PMR, and psychoeducation tailored for children and adolescents with migraine.\n\nMethods: This single-centre, open-label, randomized controlled trial will enrol 80 participants aged 13 to 17 years and diagnosed with migraine according to ICHD-3 criteria. Participants are randomized 1:1 into an intervention and control group. The intervention group will receive a 18-week, once-weekly 65-minute group therapy (comprising HIIT and PMR) plus two sessions of psychoeducation. The control group receives no intervention. Primary outcomes are changes in migraine frequency, duration, intensity and acute medication use, assessed through standardized headache diaries before and after the intervention. Secondary outcomes include changes in migraine-related disability (PedMIDAS questionnaire), exploratory analysis of physical activity patterns in a subgroup and a patient-centered evaluation of the intervention's feasibility and perceived effectiveness.\n\nDiscussion: This trial will provide evidence on the effectiveness and feasibility of a structured, time-efficient, multimodal group therapy intervention for pediatric migraine. By combining physical and psychological strategies within a supportive group setting, the program aims to overcome key limitations of adherence and offer a non-pharmacological treatment alternative. If successful, the intervention is intended to be incorporated into routine outpatient care for pediatric migraine at the Medical University of Innsbruck.",[29,64,27],"Headache Disorders",[29,66,67,68,69,70,71,72],"children","adolescents","physical activity","high intensity interval training","progressive muscle relaxation","psychoeducation","randomized controlled trial","2026-02-11",{"date":75,"type":41},"2026-02-19",{"date":77,"type":21},"2026-03-01",{"date":79,"type":21},"2027-06-30",{"name":81,"class":82},"Medical University Innsbruck","OTHER",1]