protocolSection identificationModule nctId: NCT06359899, orgStudyIdInfo id: AK0901-2001, briefTitle: A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Shanghai Ark Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: AK0901 capsule, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the efficacy of AK0901 compared to placebo in children 6 to 12 years old with ADHD., secondaryOutcomes measure: Change from baseline in ADHD-RS-5 total score at Week 4., secondaryOutcomes measure: Changes in ADHD-RS-5 inattention subscale score from baseline to each visit in the Double-Blind Treatment Period, secondaryOutcomes measure: Changes in ADHD-RS-5 hyperactivity/impulsivity subscale score from baseline to each visit in the Double-Blind Treatment Period., secondaryOutcomes measure: Change in CGI-S score from baseline to each visit in the Double-Blind Treatment Period, secondaryOutcomes measure: CGI-I scores from V3 at each visit in the Double-Blind Treatment Period, secondaryOutcomes measure: Change in WREMB-R score from baseline to each visit in the Double-Blind Treatment, secondaryOutcomes measure: Proportion of subjects with adverse events (AEs) occurring during the study, secondaryOutcomes measure: Proportion of subjects with serious adverse events (SAEs) occurring during the study, secondaryOutcomes measure: Changes in respiratory rate during the study, secondaryOutcomes measure: Changes in heart rate during the study, secondaryOutcomes measure: Changes in body temperature during the study, secondaryOutcomes measure: Changes in systolic blood pressure during the study, secondaryOutcomes measure: Changes in diastolic blood pressure during the study, secondaryOutcomes measure: Change from baseline in QT intervals from resting EKGs, secondaryOutcomes measure: Change from baseline in QTcF intervals from resting EKGs, secondaryOutcomes measure: Change from baseline in heart rate resting EKGs, secondaryOutcomes measure: Change from baseline in QRS intervals from resting EKGs, secondaryOutcomes measure: Change from baseline in PR intervals from resting EKGs, secondaryOutcomes measure: Change in CSHQ score from baseline to each visit in the Double-Blind Treatment Period, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Beijing anding hospital capital medical university, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking university sixth hospital, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False