Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms

NCT06185985 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 812P413
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score by Visit.

  The Adult ADHD Investigator Symptom Rating Scale (AISRS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (IA; 9 items) and Hyperactivity/Impulsivity (HI; 9 items). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. The sum of the ratings of all 18 items yields the raw Total score (range: 0-54; the higher the Total score, the more severe the ADHD symptoms). Post-baseline raw Total scores are converted to a change from baseline Total score. A lower change from baseline Total Score (\<0) represents a better outcome.

  Baseline and Week 4, 9, and 14

Secondary Outcomes (19)

• Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Inattention Subscale Score by Visit.

  Baseline and Week 4, 9, and 14

• Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Hyperactivity/Impulsivity Subscale Score by Visit.

  Baseline and Week 4, 9, and 14

• Change From Baseline in Adult ADHD Self-Report Scale (v1.1) Symptoms Checklist (ASRSv1.1-SC) Total Score by Visit.

  Baseline and Week 4, 9, and 14

• Change From Baseline in the Adult ADHD Self-Report Scale (v1.1) Symptoms Checklist (ASRSv1.1-SC) Inattention Subscale Score by Visit.

  Baseline and Week 4, 9, and 14

• Change From Baseline in the Adult ADHD Self-Report Scale (v1.1) Symptoms Checklist (ASRSv1.1-SC) Hyperactivity/Impulsivity Subscale Score by Visit.

  Baseline and Week 4, 9, and 14

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

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

Drug: SPN-812

Interventions

SPN-812 DRUG

Open-label

Also known as: viloxazine extended-release capsules, Qelbree

Open-Label Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for participation in this study, a participant must meet all of the following criteria:
• Is male or female, ≥18 years of age.
• Is willing and capable of providing and signing electronic informed consent.
• 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 an AISRS Total score ≥24 at Screening.
• Has a CGI-S score ≥3 at Screening.
• Has a MADRS (SIGMA) Total score \>22 at Screening and/or HAM-A (SIGH-A) Total score \>22 at Screening.
• If potential participant is a biological female, one of the following (a, b, or c) must be met:
• Has undergone menopause, defined as a biological female who reports amenorrhea for at least 12 consecutive months prior to providing informed consent.
• Is a non-pregnant Female of Childbearing Potential (FOCP) who is not seeking fertility treatment during the study and agrees to use one of the following acceptable birth control methods beginning 14 days prior to the first dose of study medication, throughout the study while taking study medication, and for 7 days following the last dose of study medication: i. Hormonal contraceptive; ii.Barrier method: simultaneous use of male condom and diaphragm or cervical cap with spermicidal foam/gel/film/cream/suppository.
• Has had bilateral tubal ligation, hysterectomy, bilateral oophorectomy (permanently sterilized) at least 6 months prior to providing informed consent.
• If potential participant is a biological male, one of the following must be met:
• Is capable of having children and agrees to use 2 methods of contraception beginning 14 days prior to the first dose of study medication, throughout the study while taking study medication, and for 7 days following the last dose of study medication.
• Has had sterilization surgery (permanently sterilized) at least 6 months prior to providing informed consent.
• Owns a functioning smartphone device, has access to an internet connection (Wi-Fi or data plan), is willing to download and use the study mobile app throughout the study, and is willing to have visual telemedicine appointments (televisits) at times designated in the study protocol.

You may not qualify if:

• A participant who meets any of the following criteria will be excluded from participation in the study:
• Has a history of substance use disorder (alcohol, opioids, etc.) within the last 6 months prior to providing informed consent with exception of nicotine and cannabis.
• Is currently taking or has taken Qelbree for treatment of ADHD in the last 3 months or is currently taking another non-stimulant medication for treatment of ADHD, like atomoxetine (Strattera), Clonidine (Catapres, Kapvay) or Guanfacine (Tenex, Intuniv). Stimulant medications for ADHD and most medications for mood symptoms (symptoms of depression and/or anxiety) are allowed.
• Is taking a prohibited concomitant medication per the Qelbree prescribing information.
• 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.
• Has a history of moderate or severe head trauma or other neurological disorder or systemic medical disease that, in the Investigator's opinion, is likely to affect central nervous system functioning. This would include participants with:
• A current diagnosis of a major neurological disorder; or
• Seizures, seizure disorder or seizure-like events; or a history of seizure disorder within the immediate family (siblings, parents); or
• Encephalopathy
• Has attempted suicide within the 6 months prior to the C-SSRS assessment at Screening, or is at significant risk of suicide, either in the opinion of the Investigator or defined as a "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behavior on the C-SSRS within the 6 months prior to the C-SSRS assessment at Screening.
• Is currently participating in another clinical trial or has participated in a clinical trial within the 60 days prior to providing informed consent.
• 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.
• Has any unstable, clinically significant cardiovascular condition that in the investigator's clinical judgement would preclude their participating in the study.
• Has any disease or taking any medication that could, in the Investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with study conduct or interpretation of results.
• History of unexplained loss of consciousness, unexplained syncope, unexplained irregular heartbeat or palpitations or near drowning with hospital admission.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (1)

ObvioHealth

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Joseph T. Hull, PhD
• Organization: Supernus Pharmaceuticals

clinicaltrials@supernus.com

240-403-5324

Study Officials

• Joseph T, Hull, PhD

  Supernus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: March 25, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 11, 2024
• Last Updated: March 27, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)