Adults 6 to 11, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)Primary· Baseline and Week 8 (End of Study)
The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 8 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (none) to 3 (severe). A Total score is calculated by adding the responses of all 18 items (range: 0-5
Group
Value
95% CI
Placebo
-11.7
± 1.48
200mg SPN-812
-17.6
± 1.43
400mg SPN-812
-17.5
± 1.52
Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) ScaleSecondary· Week 8 (End of Study)
The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 8 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "very much improved" and 7 = "very much worse." Successful therapy is indicated by a lower overall score in subsequent testing.
Group
Value
95% CI
Placebo
3.1
± 0.12
200mg SPN-812
2.6
± 0.12
400mg SPN-812
2.6
± 0.12
Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)Secondary· Baseline and Week 8 (End of Study)
The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 8 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true \[never, seldom\] and 3=very much true \[very often, very freq
Group
Value
95% CI
Placebo
-5.3
± 1.00
200mg SPN-812
-9.1
± 0.96
400mg SPN-812
-7.8
± 1.06
Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)Secondary· Baseline and Week 8 (End of Study)
The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 8 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning \[4 items\] and behavior \[6 items\]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each
Group
Value
95% CI
Placebo
-0.24
± 0.042
200mg SPN-812
-0.35
± 0.041
400mg SPN-812
-0.33
± 0.044
Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)Secondary· Week 8 (End of Study)
An additional secondary endpoint was the percentage of responders at Week 8 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 8 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders.
Group
Value
95% CI
Placebo
25.8
200mg SPN-812
36.0
400mg SPN-812
41.2
Effect of SPN-812 Assessed by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF)Secondary· Baseline and Week 8 (End of Study)
An additional secondary endpoint was the change from baseline in Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) Total score at Week 8 (End of Study). The PSI-4 questionnaire evaluates the magnitude of stress in the parent-child relationship based on the parent's perception of the child's characteristics, the personal characteristics of the parent, and the interaction between the parent and the child. The PSI-4-SF was developed for parents of children ages 1 month to 12 years. The PSI-4-SF consists of 36 items divided into three domains: parental distress, parent-child dysfunctio
Group
Value
95% CI
Placebo
-5.8
± 1.95
200mg SPN-812
-9.2
± 1.88
400mg SPN-812
-11.6
± 2.01
Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)Secondary· Baseline and Week 8 (End of Study)
An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 8 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale fr
Hyperactivity/impulsivity subscale
Group
Value
95% CI
Placebo
-5.1
± 0.78
200mg SPN-812
-8.4
± 0.76
400mg SPN-812
-8.3
± 0.81
Inattention subscale
Group
Value
95% CI
Placebo
-6.2
± 0.77
200mg SPN-812
-8.9
± 0.74
400mg SPN-812
-8.6
± 0.80
Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form (C3-SRS)Secondary· Baseline and Week 8 (End of Study)
An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 8 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, validated in 8-18 years olds, is comprised of 41 items. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true \[never, seldom\] and 3=very much true \[very often, very frequently\] b
Group
Value
95% CI
Placebo
-3.3
± 1.03
200mg SPN-812
-3.9
± 0.99
400mg SPN-812
-5.4
± 1.03
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"]Secondary· Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
An additional secondary endpoint was the percentage of subjects who were "improved" by visit; "improved" was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = "Very Much Improved" or 2 = "Much Improved". Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were "improved".
Week 1
Group
Value
95% CI
Placebo
4.1
200mg SPN-812
13.2
400mg SPN-812
10.4
Week 2
Group
Value
95% CI
Placebo
14.5
200mg SPN-812
25.8
400mg SPN-812
24.9
Week 3
Group
Value
95% CI
Placebo
21.4
200mg SPN-812
31.3
400mg SPN-812
36.7
Week 4
Group
Value
95% CI
Placebo
26.6
200mg SPN-812
41.9
400mg SPN-812
37.4
Week 5
Group
Value
95% CI
Placebo
32.7
200mg SPN-812
48.5
400mg SPN-812
44.4
Week 6
Group
Value
95% CI
Placebo
30.3
200mg SPN-812
51.0
400mg SPN-812
49.5
Week 7
Group
Value
95% CI
Placebo
36.1
200mg SPN-812
51.0
400mg SPN-812
44.8
Week 8
Group
Value
95% CI
Placebo
35.5
200mg SPN-812
47.3
400mg SPN-812
47.8
Adverse events — posted to ClinicalTrials.gov
Time frame: 8 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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NCT03247530 — Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Supernus Pharmaceuticals, Inc.
Last refreshed: 8 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03247543.