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Norepinephrine-Dopamine Reuptake Inhibitor
SPN-812 ER for ADHD
Phase 3
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
Weight of at least 20 kg if 6-11 years old and at least 35 kg for subjects aged 12 years and up.
Continues to be medically healthy with clinically normal laboratory profiles, vital signs and electrocardiograms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cgi-i will be assessed post-baseline every 3 months for up to 72 months
Awards & highlights
Study Summary
This trial is testing a new medication for kids with ADHD. It's open label, which means that everyone knows what medication is being tested. It's flexible dose, which means that the amount of medication given can be adjusted based on how the person responds. It's long-term, which means that the effects of the medication are studied over a long period of time. And it's multicenter, which means that it's being done at multiple locations.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for ADHD medications can include sleep problems, decreased appetite, mood swings, increased heart rate and blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 20 kg if I'm 6-11 years old, or at least 35 kg if I'm 12 or older.
Select...
My overall health is good, with normal lab results, vital signs, and heart tests.
Select...
I weigh at least 20 kg if I'm 6-11 years old, or at least 35 kg if I'm 12 or older.
Select...
My male partner is surgically sterile.
Select...
My overall health is good, with normal lab results, vital signs, and heart tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cgi-i will be assessed post-baseline every 3 months for up to 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cgi-i will be assessed post-baseline every 3 months for up to 72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score
Trends in Clinical Global Impression-Improvement (CGI-I) scale score
Side 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%
Vomiting
5%
Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-Label Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-Label TreatmentExperimental Treatment1 Intervention
Subjects 6-11 yrs of age will be treated with 100 to 400 mg SPN-812 ER (100 mg capsule).
Subjects 12-17 yrs of age will be treated with 100 to 600 mg SPN-812 ER (100, 200 mg capsule).
Subjects are given a choice to extend their participation in the study every 6 months for up to 72 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPN-812
2020
Completed Phase 4
~690
Find a Location
Who is running the clinical trial?
Supernus Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
12,634 Total Patients Enrolled
18 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
4,590 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Jonathan Rubin, MDStudy DirectorChief Medical Officer
5 Previous Clinical Trials
1,143 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,143 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is above the 95th percentile for my age and gender.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.You are currently using drugs or drinking alcohol.I don't have any major psychiatric or neurological disorders, but a history of depression is okay if I've been episode-free for 6 months.You currently have thoughts of hurting yourself or have shown behavior that suggests you may want to hurt yourself.You have taken part in a previous study testing SPN-812 for treating ADHD, where neither you nor the researchers knew who was receiving the actual drug and who was receiving a placebo.My overall health is good, with normal lab results, vital signs, and heart tests.I weigh at least 20 kg if I'm 6-11 years old, or at least 35 kg if I'm 12 or older.My male partner is surgically sterile.You have previously participated in a study where neither you nor the researchers knew if you were receiving the study drug or a placebo for treating ADHD.You need to use both a male condom and an intra-uterine contraceptive device for at least four weeks before starting the study drug.My overall health is good, with normal lab results, vital signs, and heart tests.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label Treatment
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT02736656 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the dangers associated with SPN-812 ER for patients?
"SPN-812 ER falls into Phase 3 of clinical trials, which means that while there is some evidence of the medication's efficacy, multiple rounds of safety testing have been conducted. Our team assesses the safety to be a 3 on a scale from 1 to 3."
Answered by AI
Do I meet the requirements to partake in this clinical experiment?
"This study is looking for 1200 patients aged 6-18 who currently have an attention deficit disorder. In order to participate, subjects must also meet the following inclusion criteria: previous participation in a double-blind study of SPN-812 for ADHD treatment, clinically normal laboratory profiles, vital signs and electrocardiograms, weight of at least 20kg if 6-11 years old or 35 kg if 12 years or older, written informed consent from parent or LAR, written informed assent/consent from subject if appropriate, use of male condom and intrauterine contraceptive device four weeks prior to first dose of study drug administration,"
Answered by AI
Does this research extend to older demographics?
"Children aged 6 to 18 years old can participate in this clinical trial. Out of the 112 trials for patients under 18, this is one of only 40 trials for patients over 65."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Oregon
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Woodland International Research Group
Paradigm Research Professionals
Bayou City Research Corporation
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
Why did patients apply to this trial?
I’ve tried other adhd medications and they haven’t worked. I was diagnosed but never put on medication, I would like to try medication treatment I struggle daily.
PatientReceived 1 prior treatment
I’ve been a student for a few years and haven’t been able to focus due to not having the resources or ability to get my adhd medication.
PatientReceived 2+ prior treatments
I have tried almost every single ADHD Ned and am still struggling to find something that really works for me. So I’m open to try something different!
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long is the trial?
PatientReceived 2+ prior treatments
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