[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07717879":3,"trial-entities:NCT07717879":142,"trial-summary:NCT07717879":146},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":47,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":65,"locations":67,"central_contacts":130,"overall_officials":136,"references":137,"see_also_links":138},"NCT07717879","SOL-ADHD-302","A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD","A Phase 3, Randomized, 6-Week, Double-blind, Placebo-controlled Trial of Solriamfetol in Children Aged 6 to \u003C12 Years With Attention Deficit Hyperactivity Disorder (ADHD)","RECRUITING","2028-06-30","2026-07","2026-07-21","2026-07-06","Axsome Therapeutics, Inc.","INDUSTRY",false,"This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to \\\u003C12 years with ADHD.","Eligible subjects are children, 6 to \\\u003C12 years of age, with a primary diagnosis of ADHD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol dose A, solriamfetol dose B or placebo once daily for 6 weeks.",[19],"ADHD",[21,19,22,23,24,25,26],"Attention deficit hyperactivity disorder","Sunosi","Solriamfetol","Axsome","Non-stimulant therapy","Dopamine norepinephrine reuptake inhibitor","INTERVENTIONAL","TREATMENT",[30],"PHASE3",{"count":32,"type":33},468,"ESTIMATED",[35,40,43],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DRUG","Solriamfetol Dose A","Solriamfetol capsules, taken once daily",[37],{"type":36,"name":41,"description":38,"armGroupLabels":42},"Solriamfetol Dose B",[41],{"type":36,"name":44,"description":45,"armGroupLabels":46},"Placebo","Placebo capsules, taken once daily",[44],[48],{"measure":49,"description":50,"timeFrame":51},"ADHD-RS-5 Total Score, Change from Baseline to Week 6","Attention Deficit\u002F Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5)","6 weeks",[],"ALL","6 Years","11 Years",{"inclusion":57,"exclusion":61,"raw_text":64},[58,59,60],"Male or female, aged 6 to \\\u003C12 years.","Primary diagnosis of ADHD according to DSM-5 criteria.","Has parents\u002Flegal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.",[62,63],"Unable to comply with study procedures.","Medically inappropriate for study participation in the opinion of the investigator.","Inclusion Criteria:\n\n* Male or female, aged 6 to \\\u003C12 years.\n* Primary diagnosis of ADHD according to DSM-5 criteria.\n* Has parents\u002Flegal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.\n\nExclusion Criteria:\n\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.",[66],"CHILD",[68,77,84,91,97,103,109,116,123],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"geoPoint":74},"Clinical Research Site","Dothan","Alabama","36303","United States",{"lat":75,"lon":76},31.22323,-85.39049,{"facility":69,"status":8,"city":78,"state":79,"zip":80,"country":73,"geoPoint":81},"Little Rock","Arkansas","72211",{"lat":82,"lon":83},34.74648,-92.28959,{"facility":69,"status":8,"city":85,"state":86,"zip":87,"country":73,"geoPoint":88},"Coral Gables","Florida","33146",{"lat":89,"lon":90},25.72149,-80.26838,{"facility":69,"status":8,"city":92,"state":86,"zip":93,"country":73,"geoPoint":94},"Jacksonville","32256",{"lat":95,"lon":96},30.33218,-81.65565,{"facility":69,"status":8,"city":98,"state":86,"zip":99,"country":73,"geoPoint":100},"Maitland","32751",{"lat":101,"lon":102},28.62778,-81.36312,{"facility":69,"status":8,"city":104,"state":86,"zip":105,"country":73,"geoPoint":106},"Orlando","32801",{"lat":107,"lon":108},28.53834,-81.37924,{"facility":69,"status":8,"city":110,"state":111,"zip":112,"country":73,"geoPoint":113},"Bardstown","Kentucky","40004",{"lat":114,"lon":115},37.80923,-85.4669,{"facility":69,"status":8,"city":117,"state":118,"zip":119,"country":73,"geoPoint":120},"Memphis","Tennessee","38119",{"lat":121,"lon":122},35.14953,-90.04898,{"facility":69,"status":8,"city":124,"state":125,"zip":126,"country":73,"geoPoint":127},"Austin","Texas","78759",{"lat":128,"lon":129},30.26715,-97.74306,[131],{"name":132,"role":133,"phone":134,"email":135},"Study Director","CONTACT","929-618-4421","akim@axsome.com",[],[],[139],{"label":140,"url":141},"Axsome Therapeutics Website","http:\u002F\u002Fwww.axsome.com",{"nct_id":4,"conditions":143,"biomarkers":145},[144],"Attention Deficit Hyperactivity Disorder",[],{"nct_id":4,"found":147,"summary":148,"prompt_version":158},true,{"design":149,"status":150,"heading":151,"summary":152,"follow_up":153,"word_count":154,"commitments":155,"compensation":156,"drugs_mentioned":157},"This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study involving approximately 468 participants. Participants will be randomly assigned to receive one of two doses of solriamfetol or a placebo.","completed","A Study of Solriamfetol for Children with ADHD","This study is testing a medication called solriamfetol to see if it is safe and effective for children aged 6 to 11 years old who have ADHD (Attention-Deficit\u002FHyperactivity Disorder). Participants will receive either one of two doses of solriamfetol or a placebo (an inactive pill that looks like the study drug) once daily for 6 weeks. The main goal is to see how much ADHD symptoms improve, measured by a special score, after 6 weeks. The study is currently recruiting about 468 children.","The primary endpoint is measured at 6 weeks, indicating the duration of the treatment period.",83,"Participants will take a capsule once daily for 6 weeks. The study measures changes in ADHD symptoms from the start of the study to Week 6.","Not stated in the trial record.",[44],"v2"]