SPN-812 ER for ADHD
Recruiting at 15 trial locations
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Supernus Pharmaceuticals, Inc.
Must be taking: SPN-812
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug SPN-812 ER for treating ADHD?
Is SPN-812 ER safe for humans?
How is the drug SPN-812 ER different from other ADHD treatments?
SPN-812 ER (viloxazine extended-release) is unique because it is a non-stimulant medication that is taken once daily, offering an alternative to traditional stimulant-based ADHD treatments. It has shown significant improvements in ADHD symptoms in children and adolescents, with a favorable safety profile in clinical trials.12456
Research Team
JR
Jonathan Rubin, MD, MBA
Principal Investigator
Supernus Pharmaceuticals, Inc.
Eligibility Criteria
This trial is for children with ADHD who weigh at least 20 kg (6-11 years old) or 35 kg (12+ years), have completed a prior SPN-812 study, and are in good health. Girls able to have babies must not be pregnant, breastfeeding, and if sexually active, use reliable birth control.Inclusion Criteria
I weigh at least 20 kg if I'm 6-11 years old, or at least 35 kg if I'm 12 or older.
I am using effective birth control or am not sexually active.
Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); written Informed Assent/Consent obtained from the subject if appropriate.
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Exclusion Criteria
My BMI is above the 95th percentile for my age and gender.
Pregnancy, breastfeeding or refusal to practice contraception during the study for FOCP
You are currently using drugs or drinking alcohol.
See 3 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Optimization
Participants' dosages are optimized for individual needs
6 months
Visits every 3 months
Maintenance
Participants continue treatment with SPN-812 to assess long-term safety and efficacy
Up to 72 months for Cohort A, up to 24 months for Cohort B
Visits every 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- SPN-812 ER
Trial OverviewThe trial tests the long-term safety and effectiveness of an extended-release medication called SPN-812 for treating pediatric ADHD. It's an open-label study where all participants know they're receiving the actual drug.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open-Label TreatmentExperimental Treatment1 Intervention
Cohort 'A' Subjects 6-11 yrs of age will be treated with 100 to 400 mg SPN-812 (100 mg capsule).
Subjects 12-17 yrs of age will be treated with 100 to 600 mg SPN-812 (100, 200 mg capsule).
Subjects are given a choice to extend their participation in the study every 6 months for up to 72 months.
Cohort 'B' Subjects 4-5 yrs of age will be treated with 100 mg SPN-812 (100 mg capsule). Subjects may participate for up to 24 months.
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Who Is Running the Clinical Trial?
Supernus Pharmaceuticals, Inc.
Lead Sponsor
Trials
49
Recruited
14,000+
Findings from Research
In a Phase 3 trial involving 297 adolescents with ADHD, the 400 mg/day dose of SPN-812 showed a statistically significant improvement in ADHD symptoms compared to placebo, while the 600 mg/day dose did not demonstrate superiority, likely due to a high placebo response.
SPN-812 was well tolerated across both doses, with a low discontinuation rate of less than 5% due to adverse events, indicating a favorable safety profile.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Phase 3 Placebo-Controlled Trial of Once-Daily 400-mg and 600-mg SPN-812 (Viloxazine Extended-Release) in Adolescents with ADHD.Nasser, A., Liranso, T., Adewole, T., et al.[2022]
In a Phase III study involving 313 children aged 6-11 with ADHD, SPN-812 (viloxazine extended-release) at doses of 200 mg and 400 mg once daily significantly improved ADHD symptoms compared to placebo, as measured by the ADHD Rating Scale (RS)-5 Total score.
The treatment was generally well tolerated, with less than 5% of participants discontinuing due to adverse events, indicating a favorable safety profile for SPN-812.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial.Nasser, A., Liranso, T., Adewole, T., et al.[2021]
In a study involving 1397 pediatric patients with ADHD, early response to treatment with SPN-812 was found to be a strong predictor of long-term efficacy, with a 75% positive predictive power after just two weeks.
The most significant indicators of treatment success were changes in ADHD Rating Scale-5 scores and Clinical Global Impressions-Improvement scores, highlighting the importance of monitoring early treatment responses.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Early response to SPN-812 (viloxazine extended-release) can predict efficacy outcome in pediatric subjects with ADHD: a machine learning post-hoc analysis of four randomized clinical trials.Faraone, SV., Gomeni, R., Hull, JT., et al.[2021]
References
A Phase 3 Placebo-Controlled Trial of Once-Daily 400-mg and 600-mg SPN-812 (Viloxazine Extended-Release) in Adolescents with ADHD. [2022]
Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial. [2021]
Early response to SPN-812 (viloxazine extended-release) can predict efficacy outcome in pediatric subjects with ADHD: a machine learning post-hoc analysis of four randomized clinical trials. [2021]
A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children. [2021]
A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD. [2020]
A Double-Blind, Randomized Study of Extended-Release Molindone for Impulsive Aggression in ADHD. [2021]
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