[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07717892":3,"trial-entities:NCT07717892":142,"trial-summary:NCT07717892":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},"NCT07717892","SOL-ADHD-304","A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD","A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to \u003C18 Years With Attention Deficit Hyperactivity Disorder (ADHD)","RECRUITING","2028-06-30","2026-07","2026-07-21","2026-06-25","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 adolescents aged 12 to \\\u003C18 years with ADHD.","Eligible subjects are adolescents, 12 to \\\u003C18 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, Adolescent Version (ADHD-RS-5)","6 weeks",[],"ALL","12 Years","17 Years",{"inclusion":57,"exclusion":61,"raw_text":64},[58,59,60],"Male or female, aged 12 to \\\u003C18 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 12 to \\\u003C18 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, randomized, double-blind study, meaning participants are randomly assigned to a treatment group and neither you nor your doctor will know which treatment you are receiving. It involves about 468 participants.","completed","A Study of Solriamfetol for Adolescents with ADHD","This study is looking at how well and how safely a medication called solriamfetol works for teenagers with Attention-Deficit\u002FHyperactivity Disorder (ADHD). You might be able to join if you are 12 to 17 years old and have been diagnosed with ADHD. Participants will receive either solriamfetol at one of two different doses, or a placebo (an inactive pill that looks like the study drug). The main goal is to see if solriamfetol can improve ADHD symptoms, measured by a specific rating scale, after 6 weeks. The study plans to enroll 468 participants, but its current status is unclear.","The main assessment for the study is at 6 weeks.",98,"You would take a capsule once daily for 6 weeks. Your parents or legal guardians would need to give written permission, and you would also need to agree to participate.","Not stated in the trial record.",[44],"v2"]