Evidence map›Paper›PMID 39373844›Full record

Trial reportCNS drugs2024

An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder.

Ann Childress, Andrew J Cutler, Lenard A Adler, Nicholas Fry, Kobby Asubonteng, Zulane Maldonado-Cruz, Andrea Formella, Jonathan Rubin

Erratum issued 2 registry-linked trialsAbstract readMulticenter StudyClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in CNS drugs, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT04016779 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

TypeinterventionalSponsorSupernus Pharmaceuticals, Inc.Ran2019 to 2020Enrolled374ConditionsAttention-Deficit/Hyperactivity Disorder (ADHD)ArmsPlacebo, SPN-812
NCT04143217 phase3completednot on this map

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With Attention-Deficit/Hyperactivity Disorder

TypeinterventionalSponsorSupernus Pharmaceuticals, Inc.Ran2020 to 2022Enrolled159ConditionsAttention-Deficit/Hyperactivity DisorderArmsSPN-812
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Ann ChildressCenter for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.
Andrew J CutlerDepartment of Psychiatry, SUNY Upstate Medical University, Syracuse, NY, USA.
Lenard A AdlerDepartment of Psychiatry, NYU Grossman School of Medicine, New York, NY, USA.
Nicholas FryChief Medical Officer and Senior Vice President of Research and Development, Supernus Pharmaceuticals, Inc, 9715 Key West Avenue, Rockville, MD, USA.
Kobby AsubontengChief Medical Officer and Senior Vice President of Research and Development, Supernus Pharmaceuticals, Inc, 9715 Key West Avenue, Rockville, MD, USA.
Zulane Maldonado-CruzChief Medical Officer and Senior Vice President of Research and Development, Supernus Pharmaceuticals, Inc, 9715 Key West Avenue, Rockville, MD, USA.
Andrea FormellaChief Medical Officer and Senior Vice President of Research and Development, Supernus Pharmaceuticals, Inc, 9715 Key West Avenue, Rockville, MD, USA.
Jonathan RubinChief Medical Officer and Senior Vice President of Research and Development, Supernus Pharmaceuticals, Inc, 9715 Key West Avenue, Rockville, MD, USA. jrubin@supernus.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveViloxazine ER (extended-release capsules; Qelbree

methodsThis was a multicenter, flexible-dose, open-label extension to a phase III, double-blind, placebo-controlled trial (NCT04016779). Viloxazine ER was initiated at 200 mg/day and adjusted (between 200 and 600 mg/day) to achieve optimal efficacy and tolerability. Trial enrollment was halted temporarily (24 March 2020 to 23 July 2020) due to the coronavirus disease 2019 (COVID-19) pandemic. Participants completing double-blind treatment during that time were offered delayed enrollment upon trial requalification. Safety outcomes were the primary objectives. Secondary objectives were efficacy outcomes, including the ADHD Investigator Symptom Rating Scale (AISRS), and were assessed relative to double-blind baseline (or trial re-entry baseline for those whose enrollment was delayed by the COVID-19 pandemic).

resultsOverall, 159 participants (133 immediate and 26 delayed rollover) received viloxazine ER, with a mean exposure of 265 ± 254.9 days. Adverse events (AEs) included (> 10% incidence) insomnia (13.8%), nausea (13.8%), headache (10.7%), and fatigue (10.1%). AEs led to discontinuation for 17.6% of participants [most commonly insomnia (2.5%), nausea (2.5%), and fatigue (1.9%)]. AISRS total score [baseline mean ± standard deviation (SD): 37.9 ± 6.3] improved by the first follow-up visit (-11.4 ± 9.5; week 2) with continued improvement at subsequent visits (last on-study visit: -18.2 ± 11.54). Similar patterns of improvement were seen for other measures of efficacy, including quality of life and executive function. Following initial dose optimization, most participants (73%) used viloxazine ER doses ≥ 400 mg/day, with 36% using doses of 600 mg/day.

conclusionsLong-term viloxazine ER use was well tolerated, with no new long-term safety findings. Improvements in ADHD symptoms and associated measures were sustained throughout trial participation. In total, 73% percent of adult participants in this long-term study used viloxazine ER doses of 400 mg or more during maintenance treatment. CLINICAL

trial registrationClinicaltrials.gov Identifier: NCT04143217.

Indexed as

Attention Deficit Disorder with HyperactivityDelayed-Action PreparationsViloxazineAdolescentAdultCapsulesDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultCapsulesDelayed-Action PreparationsViloxazine

Identifiers

PMID39373844
PMCPMC11486793

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.