Evidence map›Paper›PMID 34092822›Full record

Trial reportPsychopharmacology bulletin2021

A Phase 3 Placebo-Controlled Trial of Once-Daily 400-mg and 600-mg SPN-812 (Viloxazine Extended-Release) in Adolescents with ADHD.

Azmi Nasser, Tesfaye Liranso, Toyin Adewole, Nicholas Fry, Joseph T Hull, Fatima Chowdhry, Gregory D Busse, Zare Melyan, Andrew J Cutler, Robert L Findling and 1 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC
In one paragraph

Trial report in Psychopharmacology bulletin, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

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  20. Extended-Release Viloxazine for Children and Adolescents With Attention Deficit Hyperactivity Disorder.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Azmi NasserNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Tesfaye LiransoNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Toyin AdewoleNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Nicholas FryNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Joseph T HullNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Fatima ChowdhryNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Gregory D BusseNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Zare MelyanNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Andrew J CutlerNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Robert L FindlingNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Stefan SchwabeNasser, PhD, Liranso, PhD, Adewole, MD, Fry, Hull, PhD, Chowdhry, MD, Busse, PhD, Melyan, PhD, Schwabe, MD, PhD, Supernus Pharmaceuticals, Inc., Rockville, MD, USA; Cutler, MD, SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA; Findling, MD, Virginia Commonwealth University School of Medicine, VA, USA.
Supernus Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: Three Phase 3 trials have demonstrated the efficacy and safety of SPN-812 in pediatric subjects with ADHD. Here, we report the results of a fourth trial. Methods: Eligible adolescent subjects (N = 297) were randomized to SPN-812 (400- or 600-mg/day) or placebo. The primary efficacy endpoint was change from baseline (CFB) at end of study (EOS) in the ADHD Rating Scale-5 (ADHD-RS-5) Total score. Statistical analyses included sequential testing for multiple treatment comparisons. Key secondary endpoints included: Clinical Global Impression-Improvement (CGI-I) score at EOS and CFB at EOS in the Conners 3-Parent Short Form (Conners 3-PS) Composite T-score and Weiss Functional Impairment Rating Scale-Parent (WFIRS-P) Total average score. Results: The CFB at EOS ADHD-RS-5 Total score (least square [LS] means ± SE) for 400-mg/day, 600-mg/day SPN-812, and placebo was -18.3 ± 1.36, -16.7 ± 1.39, and -13.2 ± 1.38, respectively. The difference vs. placebo was statistically significant only for the 400-mg/day SPN-812 treatment group (600 mg/day: Conclusions: Treatment with 400- but not 600-mg/day SPN-812 resulted in statistically significant improvement in the primary endpoint. The negative result seen in the 600-mg/day SPN-812 group was likely due to an unusually high placebo response. Safety data were consistent across all doses in the SPN-812 trials.

Indexed as

Attention Deficit Disorder with HyperactivityViloxazineAdolescentChildDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodHumansTreatment OutcomeDelayed-Action PreparationsViloxazineadolescentsattention-deficit/hyperactivity disorderviloxazine

Identifiers

PMID34092822
PMCPMC8146561
OpenAlexW3170851891

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.