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Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD (ADHD Trial)
Phase 4
Waitlist Available
Research Sponsored by Supernus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1-4 and weeks 5-8
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trialtests a drug to help treat ADHD in kids 6-17.
Eligible Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1-4 and weeks 5-8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1-4 and weeks 5-8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Adverse Events During 8 Weeks of Adjunct SPN-812 Treatment
Secondary study objectives
Change From Baseline in "Evening" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
Change From Baseline in Sleep Disorders Scale for Children (SDSC) "Disorders of Excessive Somnolence" (DES) Subscale Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
+28 moreSide effects data
From 2023 Phase 4 trial • 96 Patients • NCT0478699018%
Headache
13%
Decreased Appetite
11%
Upper Respiratory Tract Infection
9%
Insomnia
7%
Nausea
5%
Diarrhoea
5%
Fatigue
5%
Irritability
5%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-Label Treatment
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-Label TreatmentExperimental Treatment1 Intervention
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPN-812
2020
Completed Phase 4
~630
Find a Location
Who is running the clinical trial?
Supernus Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
13,688 Total Patients Enrolled
18 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
5,894 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Jonathan Rubin, MD, MBAStudy DirectorChief Medical Officer
5 Previous Clinical Trials
1,993 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,686 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)