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Norepinephrine Reuptake Inhibitor

SPN-812 for Attention Deficit Hyperactivity Disorder (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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of SPN-812, a new medication for adults with ADHD. The trial will be open label, meaning that all participants will receive the study drug and will be followed for a long period of time.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124 for reporting.

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
Effect of SPN-812 on "Anxiety, Agitation, Irritability, and Anger" (SDQ-2) Subscale in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)
Effect of SPN-812 on "Appetite and Weight" (SDQ-5) Subscale in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)
Effect of SPN-812 on "Disruptions in Sleep Quality" (SDQ-4) Subscale in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)
+30 more

Side effects data

From 2020 Phase 3 trial • 374 Patients • NCT04016779
16%
Insomnia
12%
Headache
12%
Nausea
12%
Fatigue
10%
Dry mouth
10%
Decreased appetite
6%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SPN-812

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Label TreatmentExperimental Treatment1 Intervention
SPN-812 Open-Label Treatment 200mg to 600mg SPN-812 once daily for up to 156 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPN-812
2020
Completed Phase 3
~590

Find a Location

Who is running the clinical trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
13,639 Total Patients Enrolled
18 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
5,595 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Jonathan Rubin, MDStudy DirectorChief Medical Officer
5 Previous Clinical Trials
2,184 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,184 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with SPN-812 for patients?

"SPN-812 is considered to be a safe medication, as it has progressed to Phase 3 clinical trials. This means that, while there is still more research to be done, there is evidence supporting both its efficacy and safety."

Answered by AI

For this particular experiment, are elderly citizens being asked to participate?

"This particular clinical trial requires that all participants be between 18-65 years old."

Answered by AI

Are there any age, health, or other restrictions on who can join this clinical trial?

"Patients with hyperkinesis who are looking to enroll in this clinical trial should note that the age requirement is between 18 and 65. Up to 366 people can join this study."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Florida
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
CNS Healthcare
Psych Atlanta
Family Psychiatry of the Woodlands
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

I’ve tried two other ADD medications. Currently not taking anything. I need to get back on my ADHD medicine (adderall) but I haven’t been able to. I would also love to further the development of this new drug.
PatientReceived 1 prior treatment
I have ADHD and I have tried every medication under the sun and every one of them has poor side effects but I still struggle with this so I would like to see if this would work.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Can the screening visit be done via Zoom? How long do screening visits take, and is there any other compensation besides just trying the drug?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
2020. "Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04143217.
~30 spots leftby Apr 2025
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