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Taking people in United StatesPhase 4

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

Key facts

Who runs it
Supernus Pharmaceuticals, Inc.
Where
Anaheim, Atlanta, Baltimore, Bardstown, Bellaire, Berlin, Bloomfield Hills, Boston, Centennial, Cincinnati, Clermont, Coral Gables, Dallas, Decatur, Durham, Encino, Evansville, Fayetteville, Flowood, Gainesville, Garden Grove, Gresham, Hershey, Imperial, Irvington, Jacksonville, Lakeland, Las Vegas, Little Rock, Long Beach, Memphis, Miami, Neptune City, New Orleans, New York, Newport Beach, North Charleston, Orange City, Orlando, Owensboro, Petersburg, Plano, Prairieville, Richmond, Saraland, Savannah, Summerville, Tamarac, The Woodlands, Virginia Gardens, West Chester, and Winter Park, United StatesSee the 54 sites
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
286 people, planned
Started
19 Mar 2024
Expected to end
Jan 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • 100mg SPN-812
  • Placebo
Record updated
5 October 2026

Who can take part

Age
48 months to 69 months
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 28 criteriaShow less

Who can take part

  • Is male or female 4 years 0 months of 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 legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures
  • Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)
  • Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline)
  • Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline)
  • Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment
  • Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home
  • Has not initiated any behavioral intervention/therapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention/therapy during the study (e.g., subject is eligible if behavioral intervention/therapy is initiated 30 or more days prior to Visit 1 [Screening] and continues with a similar duration/frequency throughout their study)
  • Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/exclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate
  • Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk
  • Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening)
  • Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline)

Who cannot take part

  • Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine
  • Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication)
  • Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline)
  • Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study
  • Has suicidal ideation ("Yes" indicated on C-SSRS question 4 or 5) or suicidal behavior ("Yes" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide ("Yes" indicated on C-SSRS for lifetime)
  • Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and/or impact study results
  • Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and/or febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor
  • History of Bipolar Disorder diagnosed in a first degree relative
  • Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease
  • Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole
  • Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study
  • Has body mass index > 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline)
  • Has a mean resting systolic and diastolic blood pressure* that are both >95th percentile for age sex, and height and has a mean resting pulse rate* that is >95th percentile for age and sex (males: >117 bpm; females: >122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). * Note: The mean of three measurements while seated
  • Has global development delay or intellectual disability by medical history
  • Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening)
  • Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study

Where in United States

  • Advanced Research Center (ARC), Inc.Anaheim, United StatesContact: Olivia ElbaumTaking people
  • Advanced Discovery Research, LlcAtlanta, United StatesContact: Olivia ElbaumTaking people
  • Clinical Integrative Research Center of AtlantaAtlanta, United StatesContact: Olivia ElbaumTaking people
  • Kennedy Krieger InstituteBaltimore, United StatesContact: Olivia ElbaumTaking people
  • Kentucky Pediatric/ Adult ResearchBardstown, United StatesContact: Olivia ElbaumTaking people
  • Houston Clinical Trials, LLCBellaire, United StatesContact: Olivia ElbaumNo longer taking part
  • Hassman Research InstituteBerlin, United StatesContact: Olivia ElbaumNo longer taking part
  • NeuroBehavioral Medicine GroupBloomfield Hills, United StatesContact: Olivia ElbaumTaking people
  • Boston Children's HospitalBoston, United StatesContact: Olivia ElbaumTaking people
  • IMMUNOe Research CentersCentennial, United StatesContact: Olivia ElbaumTaking people
  • Cincinnati Children's Hospital and Medical CenterCincinnati, United StatesContact: Olivia ElbaumTaking people
  • Vertex Clinical Research, LLCClermont, United StatesContact: Olivia ElbaumNo longer taking part
  • Luna Research CenterCoral Gables, United StatesContact: Olivia ElbaumTaking people
  • JavaraDallas, United StatesContact: Olivia ElbaumNo longer taking part
  • CenExcel iResearch LLCDecatur, United StatesContact: Olivia ElbaumTaking people
  • Duke UniversityDurham, United StatesContact: Olivia ElbaumTaking people
  • Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Encino]Encino, United StatesContact: Olivia ElbaumNo longer taking part
  • Qualmedica Research, LLCEvansville, United StatesContact: Olivia ElbaumNo longer taking part
  • Preferred Research Partners-NWA, LLCFayetteville, United StatesContact: Olivia ElbaumNo longer taking part
  • Precise Research CentersFlowood, United StatesContact: Olivia ElbaumTaking people
  • Sarkis Clinical TrialsGainesville, United StatesContact: Olivia ElbaumNo longer taking part
  • National Institute of Clinical Research (PICR)Garden Grove, United StatesContact: Olivia ElbaumNo longer taking part
  • Cyn3rgy ResearchGresham, United StatesContact: Olivia ElbaumTaking people
  • Penn State Health Medical Group - Psychiatry and Behavioral HealthHershey, United StatesContact: Olivia ElbaumTaking people
  • Sun Valley Research CenterImperial, United StatesContact: Olivia ElbaumTaking people
  • Med Clinical ResearchIrvington, United StatesContact: Olivia ElbaumTaking people
  • Clinical NeuroScience Solutions IncJacksonville, United StatesContact: Olivia ElbaumTaking people
  • Accel Research Sites - Lakeland CRULakeland, United StatesContact: Olivia ElbaumNo longer taking part
  • Clinical Research of Southern Nevada, LLCLas Vegas, United StatesContact: Olivia ElbaumTaking people
  • Preferred Research Partners, IncLittle Rock, United StatesContact: Olivia ElbaumTaking people
  • Alliance ResearchLong Beach, United StatesContact: Olivia ElbaumTaking people
  • Clinical Neuroscience Solutions, Inc.Memphis, United StatesContact: Olivia ElbaumTaking people
  • Avantis Clinical Research, LLCMiami, United StatesContact: Olivia ElbaumTaking people
  • Jersey Shore University Medical CenterNeptune City, United StatesContact: Olivia ElbaumTaking people
  • Delricht Research-Touro Medical CenterNew Orleans, United StatesContact: Olivia ElbaumNo longer taking part
  • Icahn School of Medicine at Mount SinaiNew York, United StatesContact: Olivia ElbaumNo longer taking part
  • Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Newport Beach]Newport Beach, United StatesContact: Olivia ElbaumNo longer taking part
  • Coastal Carolina Research CenterNorth Charleston, United StatesContact: Olivia ElbaumTaking people
  • Medical Research Group of Central FloridaOrange City, United StatesContact: Olivia ElbaumTaking people
  • APG Research, LLCOrlando, United StatesContact: Olivia ElbaumTaking people
  • Clinical Neuroscience Solutions, Inc.Orlando, United StatesContact: Olivia ElbaumTaking people
  • Qualmedica Research, LLCOwensboro, United StatesContact: Olivia ElbaumNo longer taking part
  • Clinical Research Partners, LLCPetersburg, United StatesContact: Olivia ElbaumTaking people
  • Aim Trials, LLCPlano, United StatesContact: Olivia ElbaumTaking people
  • DelRicht ResearchPrairieville, United StatesContact: Olivia ElbaumTaking people
  • Virginia Commonwealth University, Virginia Treatment Center for ChildrenRichmond, United StatesContact: Olivia ElbaumTaking people
  • The Center for Clinical Trials, IncSaraland, United StatesContact: Olivia ElbaumTaking people
  • CenExel iResearch, LLCSavannah, United StatesContact: Olivia ElbaumTaking people
  • Coastal Pediatric ResearchSummerville, United StatesContact: Olivia ElbaumTaking people
  • D&H Tamarac Research CenterTamarac, United StatesContact: Olivia ElbaumTaking people
  • Family Psych of The WoodlandsThe Woodlands, United StatesContact: Olivia ElbaumTaking people
  • Hope Research Network, LLC.Virginia Gardens, United StatesContact: Olivia ElbaumTaking people
  • CincyScienceWest Chester, United StatesContact: Olivia ElbaumNo longer taking part
  • Pediatric Neurology and Epilepsy SpecialistsWinter Park, United StatesContact: Olivia ElbaumTaking people

About the trial

What the trial wants to find out

This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

The 2 groups in the trial

  • PlaceboPlacebo, for comparison

    Placebo, qd

  • SPN-812Treatment being tested

    SPN-812, qd

    Treatment: 100mg SPN-812

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Record updated
5 October 2026