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

Purpose

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

Condition

  • Attention-Deficit/Hyperactivity Disorder

Eligibility

Eligible Ages
Between 48 Months and 69 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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. 2. 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. 3. 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). 4. Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline). 5. Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline). 6. Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment. 7. 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. 8. 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). 9. 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. 10. Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk. 11. 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). 12. Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline). Exclusion Criteria: 1. 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. 2. 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. 3. History of Bipolar Disorder diagnosed in a first degree relative. 4. Has global development delay or intellectual disability by medical history. 5. Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease. 6. Has body mass index > 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline). 7. 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. 8. Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening). 9. 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. 10. Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole. 11. 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. 12. 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). 13. 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). 14. 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. 15. Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study. 16. 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).

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
Placebo, qd
  • Drug: Placebo
    Placebo will be administered once daily
Experimental
SPN-812
SPN-812, qd
  • Drug: 100mg SPN-812
    100mg SPN-812 will be administered once daily and compared to Placebo
    Other names:
    • SPN-812

Recruiting Locations

The Center for Clinical Trials, Inc.
Saraland, Alabama 36571
Contact:
251-341-7021
info@thecenterforclinicaltrials.com

Preferred Research Partners, Inc.
Little Rock, Arkansas 72211
Contact:
501-553-9987
info@preferredresearchpartners.com

Advanced Research Center (ARC), Inc.
Anaheim, California 92805
Contact:
714-999-6688
contact@arctrials.com

Sun Valley Research Center
Imperial, California 92251
Contact:
760-545-0123
svrcinfo@sunvalleyb.com

Alliance Research
Long Beach, California 90807
Contact:
562-548-8500
Research@asclepes.com

IMMUNOe Research Centers
Centennial, Colorado 80112
Contact:
303-771-9000
verosinfo@veroshealth.com

Luna Research Center
Coral Gables, Florida 33134
Contact:
305-613-7761

Sarkis Clinical Trials
Gainesville, Florida 32607
Contact:
352-333-0094

Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32256
Contact:
904-281-5757

Avantis Clinical Research LLC
Miami, Florida 33155
Contact:
305-515-9006
info@avantisclinicalresearch.com

Hope Research Network, LLC.
Miami, Florida 33166
Contact:
786-953-8858
info@hoperesearchnetwork.com

Medical Research Group of Central Florida
Orange City, Florida 32763
Contact:
386-775-7627

Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801
Contact:
407-425-5100
orlinfo@cnshealthcare.com

APG Research LLC
Orlando, Florida 32803
Contact:
407-423-7149
kkenworthyapg@gmail.com

D&H Tamarac Research Center
Tamarac, Florida 33321
Contact:
786-375-6210
info@dhnrc.com

Pediatric Neurology and Epilepsy Specialists
Winter Park, Florida 32789

Advanced Discovery Research LLC
Atlanta, Georgia 30318
Contact:
470-777-8839
contact@advdiscovery.com

Clinical Integrative Research Center of Atlanta
Atlanta, Georgia 30328
Contact:
678-705-7341

CenExcel iResearch, LLC
Decatur, Georgia 30030
Contact:
404-537-1281

CenExel iResearch, LLC.
Savannah, Georgia 31405
Contact:
912-744-0800

Qualmedica Research, LLC.
Evansville, Indiana 47715
Contact:
812-205-2475

Kentucky Pediatric/Adult Research
Bardstown, Kentucky 40004
Contact:
502-349-1569
kpar@kpar.us

Qualmedica Research, LLC.
Owensboro, Kentucky 42301
Contact:
270-685-4589

DelRicht Research (Touro Medical Center)
New Orleans, Louisiana 70115
Contact:
504-336-2667
info@delricht.com

DelRicht Research
Prairieville, Louisiana 70769
Contact:
225-412-0316
info@delricht.com

Kennedy Krieger Institute
Baltimore, Maryland 21205
Contact:
443-923-3850

Boston Children's Hospital
Boston, Massachusetts 02445
Contact:
617-355-1118
benamin.mills@childrens.harvard.edu

Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302
Contact:
248-290-5400
info@neurobmg.com

Precise Research Centers
Flowood, Mississippi 39232
Contact:
601-420-5812

Clinical Research of Southern Nevada, LLC.
Las Vegas, Nevada 89128
Contact:
702-750-0000
kluna.cpbm@gmail.com

Med Clinical Research
Irvington, New Jersey 07111
Contact:
908-798-8373
info@medclinicalresearch.com

Jersey Shore University Medical Center
Neptune City, New Jersey 07753
Contact:
732-897-3640
andrew.layman@hmhn.org

Icahn School of Medicine at Mount Sinai
New York, New York 10028
Contact:
212-241-8012
adhd.research@mssm.edu

Duke University
Durham, North Carolina 27705
Contact:
919-681-1100

Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio 45229
Contact:
513-636-9763
ADHDResearch@cchmc.org

CincyScience
West Chester, Ohio 45069
Contact:
513-646-4864
research@cincyscience.com

Cyn3rgy Research
Gresham, Oregon 97030
Contact:
503-907-2179
support@cyn3rgy.com

Penn State Health Medical Group - Psychiatry and Behavioral Health
Hershey, Pennsylvania 17033
Contact:
717-531-0003
rmyers12@pennstatehealth.psu.edu

Coastal Carolina Research Center
North Charleston, South Carolina 29405
Contact:
843-856-3784
CCRC@CoastalCarolinaResearch.com

Coastal Pediatric Research
Summerville, South Carolina 29486
Contact:
843-870-2225
info.research@cpakids.com

Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
Contact:
901-843-1045

Houston Clinical Trials, LLC.
Bellaire, Texas 77401
Contact:
713-527-8839

Javara
Dallas, Texas 75230
Contact:
214-764-2332

AIM Trials, LLC
Plano, Texas 75093
Contact:
469-364-8804
info@aimtrials.com

Family Psych of The Woodlands
The Woodlands, Texas 77381
Contact:
281-367-1015
info@woodlandspsych.com

Clinical Research Partners, LLC
Petersburg, Virginia 23805
Contact:
804-921-9592
Recruitment@ClinicalResearchRVA.com

Virginia Commonwealth University, Virginia Treatment Center for Children
Richmond, Virginia 23220
Contact:
804-628-8736

More Details

NCT ID
NCT04781140
Status
Recruiting
Sponsor
Supernus Pharmaceuticals, Inc.

Study Contact

Joseph T Hull, PhD
240-403-5324
jhull@supernus.com

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter, 2-arm (1:1), parallel-group, efficacy and safety/tolerability fixed-dose study of SPN-812 in preschool-age children (4 to 5 years old) with ADHD. Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 6 weeks. The total duration of the study is up to 10 weeks.