SPN-812 for ADHD

Recruiting at 1 trial location

Overseen By Leslie Brijbasi

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Supernus Pharmaceuticals, Inc.

Must not be taking: Non-stimulants, Qelbree

Disqualifiers: Substance use disorder, Neurological disorder, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 14 weeks

750 Participants Needed

Trial Summary

What is the purpose of this trial?

Open label, flexible dose, decentralized clinical trial evaluating the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms.

Eligibility Criteria

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.

Inclusion Criteria

Has a CGI-S score ≥3 at Screening

Has an AISRS Total score ≥24 at Screening

I am willing and able to give my consent electronically.

Exclusion Criteria

I am pregnant, nursing, or not using birth control while sexually active with a male partner.

I have had a serious head injury or neurological condition that may affect my brain function.

Has any history of schizophrenia, schizoaffective disorder, or bipolar disorder, or has any other psychiatric disorders in the investigator's clinical judgement would interfere with their ability to participate in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Up to 2 visits (virtual)

Treatment

Participants receive SPN-812 with flexible dosing for up to 14 weeks

14 weeks

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SPN-812

Trial Overview 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.

Participant Groups

Group I: Open-Label Treatment Experimental Treatment 1 Intervention

SPN-812 (200mg to 600mg once daily) for up to 14 weeks

SPN-812 is already approved in United States for the following indications:

Approved in United States as Qelbree for:

• Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older

Who Is Running the Clinical Trial?

Supernus Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

14,000+