Clinical trial NCT04781140: Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 286
Sex: ALL
Minimum age (years): 48
Maximum age (years): 69
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Total Score at End of Study (Week 6)
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change from Baseline in the Clinical Global Impression of Severity (CGI-S) Score at End of Study (Week 6)
timeFrame: Baseline and Week 6
measure: Clinical Global Impression of Change (CGI-C) Score at End of Study (Week 6)
timeFrame: Week 6
measure: Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Hyperactivity/Impulsivity Subscale Score at End of Study (Week 6)
timeFrame: Baseline and Week 6
measure: Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Inattention Subscale Score at End of Study (Week 6)
timeFrame: Baseline and Week 6
measure: Clinical Global Impression of Severity (CGI-S) Responder Rate (percentage of subjects with CGI-S score of 1 or 2) at End of Study (Week 6)
timeFrame: Baseline and Week 6
measure: Clinical Global Impression of Change (CGI-C) Responder Rate (percentage of subjects with CGI-C score of 1 or 2) at End of Study (Week 6)
timeFrame: Week 6
measure: Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Responder Rate (percentage of subjects with ≥ 50% Reduction in Change from Baseline) at End of Study (Week 6)
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Saraland
country: United States
facility: The Center for Clinical Trials, Inc.
state: Alabama
city: Fayetteville
country: United States
facility: Preferred Research Partners - NWA, LLC
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center (ARC), Inc.
state: California
city: Garden Grove
country: United States
facility: National Institute of Clinical Research (NICR)
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Long Beach
country: United States
facility: Alliance Research
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Coral Gables
country: United States
facility: Luna Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites-LKD CRU
state: Florida
city: Miami
country: United States
facility: Avantis Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: Hope Research Network, LLC.
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: APG Research LLC
state: Florida
city: Tamarac
country: United States
facility: D&H Tamarac Research Center
state: Florida
city: Atlanta
country: United States
facility: Advanced Discovery Research LLC
state: Georgia
city: Atlanta
country: United States
facility: Clinical Integrative Research Center of Atlanta
state: Georgia
city: Decatur
country: United States
facility: CenExcel iResearch, LLC
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC.
state: Georgia
city: Evansville
country: United States
facility: Qualmedica Research, LLC.
state: Indiana
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Owensboro
country: United States
facility: Qualmedica Research, LLC.
state: Kentucky
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research (Touro Medical Center)
state: Louisiana
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Las Vegas
country: United States
facility: Clinical Research of Southern Nevada, LLC.
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Irvington
country: United States
facility: Med Clinical Research
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital and Medical Center
state: Ohio
city: West Chester
country: United States
facility: CincyScience
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC.
state: Texas
city: Dallas
country: United States
facility: Javara
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
city: The Woodlands
country: United States
facility: Family Psych of The Woodlands
state: Texas
city: Petersburg
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University, Virginia Treatment Center for Children
state: Virginia
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Jonathan Rubin, MD, MBA
role: STUDY_DIRECTOR
References: