CompletedPhase 4

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

United States161 participantsStarted 2024-03-25

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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

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

Timeframe: Baseline and Week 4, 9, and 14

NCT IDNCT06185985

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-03

Results submitted2026-02-16

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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