Clinical Trial 43426

Garden Grove, CA 92845


This study will evaluate the efficacy and safety of SPN-812, an extended-release formulation of viloxazine, in adults.

Inclusion Criteria:

  1. Is male or female, aged 18 to ≤ 65 years at screening.
  2. Is able to read and understand the Informed Consent Form (ICF).
  3. Written informed consent obtained from the subject (a signed ICF).
  4. Weight within the normal or overweight ranges according to accepted values of the Body Mass Index Chart (18.0 to 35 kg/m2).
  5. Is able to swallow capsules whole, without crushing, chewing or cutting.
  6. Is willing and able to attend study appointments within the specified time windows.
  7. Has a primary diagnosis of ADHD according to the DSM-5 classification, with diagnosis made at least 6 months prior to screening and confirmed with Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT).
  8. Has an AISRS total score of ≥ 26 at the Screening Visit and at the Baseline Visit (V2, Day 1).
  9. Has a CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit (V1) and Baseline Visit (V2, Day 1).
  10. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose of SM and throughout the study:

    1. Simultaneous use of male condom and intra-uterine contraceptive device placed at least 4 weeks prior to first SM administration
    2. Surgically sterile male partner
    3. Simultaneous use of male condom and diaphragm with spermicide
    4. Established hormonal contraceptive

    Females are considered not to be of childbearing potential if they are either post-menopausal (amenorrhea for at least 2 years and serum follicle stimulating hormone (FSH) level of >40 IU/L) or permanently sterilized (e.g., bilateral tubal ligation, hysterectomy, bilateral oophorectomy for 6 months minimum prior to screening).

  11. Males must:

    1. Use 2 methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from the Baseline Visit to ≥ 1 month after the last dose of SM, or
    2. Have been surgically sterilized prior to the Screening Visit.

Qualified Participants May Receive:

Monetary compensation and study-related care at no cost to the participant.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.