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Open-Label Treatment for Attention Deficit Hyperactivity Disorder (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4, 9, and 14

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, 9, and 14

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score by visit.

Secondary outcome measures

Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Inattention and Hyperactivity/Impulsivity Subscale scores by visit.

Other outcome measures

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 2020 Phase 3 trial • 374 Patients • NCT04016779

16%

Insomnia

12%

Headache

12%

Nausea

12%

Fatigue

10%

Dry mouth

10%

Decreased appetite

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

SPN-812

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 3

~590

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor

47 Previous Clinical Trials

13,048 Total Patients Enrolled

18 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

5,004 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.

Is the enrollment for this research study still ongoing?

"Based on the information provided by clinicaltrials.gov, this particular trial is not currently accepting new participants. The initial posting date was January 1st, 2024, and it was last updated on December 15th, 2023. However, it's worth noting that there are presently 177 other studies actively seeking participants."

Answered by AI

What is the level of safety associated with Open-Label Treatment for individuals?

"Given that Open-Label Treatment is already approved, our assessment at Power rates its safety as a 3 on a scale of 1 to 3. This rating reflects the Phase 4 trial status and the existing approval for this treatment."

Answered by AI