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Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

StatusRecruiting
PhasePhase 4
Started2024-03-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 18 months later Jun 2026 → Jan 2028
See other at-risk trials from Supernus Pharmaceuticals, Inc.

Amendment history

2026-09-09
Study Status v20
Primary completion pushed: 2026-06 → 2028-01
Completion pushed: 2026-06 → 2028-01
2026-02-16
Study Status, Contacts/Locations v19
Study sitescontacts updated at 10 of 47 sites
2026-01-06
Study Status, Contacts/Locations v18
Primary completion date2025-12→2026-06
Completion date2025-12→2026-06
Study sites49→47
2025-11-06
Study Status, Contacts/Locations v17
Study sitescontacts updated at 1 of 49 sites
2025-10-07
Study Status, Contacts/Locations v16
Study sites47→49
Show 15 earlier versions
2025-05-06
Study Status, Eligibility, Contacts/Locations v15
Study sites44→47
Eligibility criteria+1,167 characters
Inclusion Criteria: Is male or female between 4 years 0 months andof age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy. Subject's parent(s) or le [...] s (are) willing and able to provide written informed consent, including a signed Informed Consent Form and documentation of assent (if applicable) by the subject before completing any study related procedures. Has a prima [...] HD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at BaselineVisit 2 (Day 1Baseline). Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 [...] [...]
2025-04-03
Study Status, Contacts/Locations v14
Study sites43→44
2025-01-29
Study Status, Contacts/Locations v13
Study sites39→43
2024-12-02
Study Status, Contacts/Locations v12
Study sites35→39
2024-11-11
Study Status, Contacts/Locations v11
Study sites32→35
2024-10-03
Study Status, Outcome Measures, Contacts/Locations v10
Study sites16→32
Secondary endpointsdetails revised at 7 of 7 entries
2024-08-22
Study Status, Contacts/Locations v9
Study sites1→16
2024-03-22
Not Yet Recruiting→Recruiting Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01→confirmed 2024-03-19
Enrollment target160→286
Study sites0→1
Eligibility criteria+120 characters
Inclusion Criteria: Is male or female, between 4 years 0 months and 5 years 9 months of age at Scr [...] a primary diagnosis of ADHD according to DSM-IV-TR criteria, and confirmed with the Kiddie Schedule for Affective Disord [...] creening and at Baseline (Day 1). Has a CGI-S score of ≥ 4 (moderately illmoderate or worse) at Screening and at Baseline (Day 1). Has undergo [...] he study if they meet all other inclusion/exclusion criteria. Has no current condition in the opinion of the Investigator [...] r Disorder diagnosed in a first degree relative. Has global developmentaldevelopment delay or intellectual disability [...] [...]
Secondary endpoints6 to 7 entries
EffectChange offrom SPN-812Baseline on the global assessment of severity of illness as assessed byin the Clinical Global Impression -of Severity of Illness (CGI-S) Scale. EffectScore at End of SPN-812Study on(Week the global assessment of improvement as assessed by the 6) Clinical Global Impression -of ImprovementChange (CGI-IC) Scale. EffectScore at End of SPN-812 on the clinical response rate of improvement assessed by the categorical Clinical Global Impression - ImprovementStudy (CGI-I)Week responder rate. Effect of SPN-812 on the clinician response rate as measured by 50% Responder Rate on [...] [...]
Primary endpoints1 entry, revised
EfficacyChange offrom SPN-812Baseline on ADHD symptoms as assessed byin the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P). Total Score at End of Study (Week 6)
2023-11-14
Study Status v7
Primary completion date2025-01→2025-12
Completion date2025-01→2025-12
Start date2023-12→2024-01
2023-09-27
Study Status, Contacts/Locations v6
Start date2023-08→2023-12
2023-06-30
Study Status v5
Start date2023-06→2023-08
2023-04-13
Study Status v4
Start date2023-03→2023-06
2022-10-26
Study Status v3
Primary completion date2023-12-31→2025-01
Completion date2023-12-31→2025-01
Start date2022-06→2023-03
2022-01-30
Study Identification, Study Status v2
Primary completion date2022-10-31→2023-12-31
Completion date2022-10-31→2023-12-31
Start date2021-05-31→2022-06
Study title+38 characters
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
2021-03-03
Study Identification, Study Status v1
Study title-62 characters
A Phase 4, Double-blind, Placebo-Controlled Efficacy and Safety StudyEvaluation of SPN-812 in Preschool-age Children 4 to 5 Years Old With ADHD
2021-03-01
Original filing
This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.
Trial Details
NCT Number NCT04781140
Lead Sponsor Supernus Pharmaceuticals, Inc.
Conditions Attention-Deficit/Hyperactivity Disorder
Enrollment 286 participants
Start Date 2024-03-19
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-11