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SPN-812 for ADHD

Phase 4
Recruiting
Research Sponsored by Supernus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders; Fifth Edition, Text Revision (DSM-5-TR) as confirmed with the Mini-International Neuropsychiatric Interview for ADHD Studies (MINI-AS)
Has had sterilization surgery (permanently sterilized) at least 6 months prior to providing informed consent
Must not have
Is a FOCP who is pregnant, nursing, sexually active with a male partner and not willing to use one of the acceptable birth control methods throughout the study and/or is seeking fertility treatment
Is taking a prohibited concomitant medication per the Qelbree prescribing information
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, 9, and 14
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is studying the effectiveness and safety of SPN-812 in adults with ADHD and mood symptoms. It is an open trial, meaning that participants will know what medication they are receiving, and the

Who is the study for?
Adults over 18 with ADHD and mood symptoms, who can sign consent and use the study app for telemedicine appointments. Women must not be pregnant or nursing and agree to birth control if of childbearing potential; men should agree to contraception too. Excludes recent substance abusers, those on certain medications, or with severe mental health issues.
What is being tested?
The trial is testing SPN-812 (Qelbree®) in adults with ADHD and mood symptoms. It's an open-label study where everyone gets the drug at flexible doses to see how effective and safe it is when participants manage their own treatment using a mobile app.
What are the potential side effects?
While specific side effects are not listed here, typical ones may include dizziness, sleepiness, nausea, vomiting, tiredness, decreased appetite, trouble sleeping and irritability. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with ADHD according to the DSM-5-TR.
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I have been permanently sterilized for over 6 months.
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I am a woman able to have children, not pregnant, not seeking fertility treatment, and will use birth control during the study.
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I have not had a menstrual period for at least 12 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am pregnant, nursing, or not using birth control while sexually active with a male partner.
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I am not taking any medication that Qelbree's guidelines say I shouldn't.
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I have had unexplained fainting, irregular heartbeat, or a near-drowning incident that required hospitalization.
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I am currently using or have used Qelbree or another non-stimulant for ADHD in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, 9, and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, 9, and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score by visit.
Secondary study objectives
Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Inattention and Hyperactivity/Impulsivity Subscale scores by visit.
Other study objectives
Change from baseline in Adult ADHD Self-Report Scale (v1.1) Symptoms Checklist (ASRSv1.1-SC) Total score by visit.
Change from baseline in General Anxiety Disorder 7-item (GAD-7) Total Score by visit
Change from baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 14
+31 more

Side effects data

From 2023 Phase 4 trial • 96 Patients • NCT04786990
18%
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

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Label TreatmentExperimental Treatment1 Intervention
SPN-812 (200mg to 600mg once daily) for up to 14 weeks
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
13,034 Total Patients Enrolled
18 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
5,240 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~83 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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