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New treatment option for Attention-Deficit/Hyperactivity Disorder
Official title Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
ClinicalTrials.gov ID: NCT04781140
What this study is testing
What is 100mg SPN-812?
100mg SPN-812 is an investigational medicine, given as an once-daily, being studied as a potential treatment for attention-deficit/hyperactivity disorder.
Also referred to as SPN-812.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.
- Phase 4: studies an already-approved treatment
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 48 to 69
You may be able to join if
- 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...
- Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia -...
- 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).
You likely can't join if
- , 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 how well it works assessments, safety assessments or increase...
- 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...
- Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline). Exclusion Criteria:
- 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...
- Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g...
See the full eligibility criteria
Who can join
- 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...
- 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...
- people 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/
What rules you out
- , 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 how well it works 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). Exclusion Criteria:
- 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...
- 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...
- History of Bipolar Disorder diagnosed in a first degree relative.
- Has global development delay or intellectual disability by medical history.
- Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease.
- 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...
- Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).
- Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of how well it works or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance...
- 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 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 people receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant...
- 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.
- Any reason that, in the opinion of the Investigator, would prevent the subject from participating in 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...
The study team makes the final eligibility decision.
Where it's taking place
- Saraland, Alabama, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Imperial, California, United States
- Long Beach, California, United States
- Centennial, Colorado, United States
- Coral Gables, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- Tamarac, Florida, United States
- Winter Park, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Savannah, Georgia, United States
- Evansville, Indiana, United States
- Bardstown, Kentucky, United States
- Owensboro, Kentucky, United States
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 48 months to 69 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saraland, Alabama, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Imperial, California, United States; Long Beach, California, United States; Centennial, Colorado, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.