Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD

NCT04016779 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 812P306
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 37

Brief Summary

This study will evaluate the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) in adults 18-65 years of age with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

Attention-Deficit/Hyperactivity Disorder (ADHD), Adult ADHD,

Outcome Measures

Primary Outcomes (1)

• Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score

  The Primary Endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score at Week 6. The 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 (9 items) and Hyperactivity/Impulsivity (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. A Total score is calculated by summating the ratings of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). A lower change from baseline AISRS Total score (\<0) represents a better outcome.

  Baseline and Week 6

Secondary Outcomes (21)

• Effect of SPN-812 on the Clinical Global Impression - Severity of Illness (CGI-S) Scale

  Baseline and Week 6

• Effect of SPN-812 on the Clinical Response Rate as Assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale

  Week 6

• Effect of SPN-812 on the Clinical Global Impression - Improvement (CGI-I) Scale

  Week 6

• Effect of SPN-812 on Clinical Response Rate as Assessed by the Clinical Global Impression - Improvement (CGI-I) Scale

  Week 6

• Effect of SPN-812 on Symptoms of Anxiety as Assessed by the Generalized Anxiety Disorder 7-Item (GAD-7) Scale

  Baseline and Week 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, qd, oral capsule

Drug: Placebo

SPN-812

EXPERIMENTAL

SPN-812, qd, oral capsule

Drug: SPN-812

Interventions

Placebo DRUG

Placebo will be administered once daily

Also known as: PBO

Placebo

SPN-812 DRUG

SPN-812 will be administered once daily and compared to Placebo

Also known as: Viloxazine extended-release capsules

SPN-812

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female, aged 18 to ≤ 65 years at screening.
• Is able to read and understand the Informed Consent Form (ICF).
• Written informed consent obtained from the subject (a signed ICF).
• Weight within the normal or overweight ranges according to accepted values of the Body Mass Index Chart (18.0 to 35 kg/m2).
• Is able to swallow capsules whole, without crushing, chewing or cutting.
• Is willing and able to attend study appointments within the specified time windows.
• 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).
• Has an AISRS Adult ADHD (Attention-Deficit/Hyperactivity Disorder) Investigator Symptom Rating Scale total score of ≥ 26 at the Screening Visit and at the Baseline Visit (V2, Day 1).
• Has a CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit (V1) and Baseline Visit (V2, Day 1).
• 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:
• Simultaneous use of male condom and intra-uterine contraceptive device placed at least 4 weeks prior to first SM administration
• Surgically sterile male partner
• Simultaneous use of male condom and diaphragm with spermicide
• 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).

You may not qualify if:

• Has previously enrolled in a SPN-812 study.
• Is currently participating in another clinical trial or has participated in a clinical trial within 60 days prior to the first Screening Visit.
• Is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel.
• Female subjects who are pregnant, lactating and/or sexually active and not agreeing to use one of the acceptable birth control methods throughout the study.
• Has history of severe drug allergy or hypersensitivity, or known hypersensitivity, to the study medication or excipients.
• Has 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 subjects 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 any history of schizophrenia, schizoaffective disorder, bipolar disorder, borderline personality disorder, antisocial personality disorder, narcissistic personality disorder, autism, post-traumatic stress disorder or obsessive-compulsive disorder.
• Has any current psychiatric disorder (per DSM-5 criteria) other than ADHD with the following exceptions: ADHD is primary diagnosis with comorbidity/secondary diagnoses of major depression disorder (MDD), nicotine dependence, social anxiety disorder, generalized anxiety disorder, or phobias, and subject is not receiving pharmacological treatment for the comorbidity/secondary diagnoses (e.g., antidepressant for MDD) at time of screening nor for the duration of study.
• Has a Symptoms of Depression Questionnaire (SDQ) mean score \>3.0 at screening.
• Has a Hamilton Anxiety Rating Scale (HAM-A) score of \> 21 at screening.
• Has organic mental disorders, or mental disorders due to a general medical condition (per DSM-5 criteria).
• Has a current diagnosis or history of substance use disorder including alcohol use disorder (excluding nicotine and caffeine) (per DSM-5 criteria) within the 12 months prior to screening; or is assessed by the Investigator as having regularly consumed alcohol exceeding 21 units for males and 14 units for females per week (1 unit equals 340 mL of beer, 115 mL of wine, or 43 mL of spirits) within the 12 months prior to screening.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (37)

Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Artemis Research Institute for Clinical Research

Riverside, California, 92078, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Artemis Institute for Clinical Research

San Marcos, California, 92078, United States

Location

Collaborative Neuroscience Network LLC

Torrance, California, 90502, United States

Location

Gulfcoast Research Center

Fort Myers, Florida, 33912, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32217, United States

Location

Meridien Research

Lakeland, Florida, 33805, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Clinical Neuroscience Solutions Inc.

Orlando, Florida, 32801, United States

Location

CNS Healthcare

Orlando, Florida, 32806, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Psych Atlanta

Marietta, Georgia, 30060, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

St. Charles Psychiatric Associates Midwest Research Center

Saint Charles, Missouri, 63304, United States

Location

Alivation Research, LLC

Lincoln, Nebraska, 68526, United States

Location

Altea Research Institute

Las Vegas, Nevada, 10549, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Hassmann Research Institute

Marlton, New Jersey, 08053, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Bioscience Research

Mount Kisco, New York, 10549, United States

Location

The Medical Research Network LLC

New York, New York, 10128r, United States

Location

Paradigm Research Professionals

Oklahoma City, Oklahoma, 73188, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

BioBehavioral Research of Austin P.C.

Austin, Texas, 78759, United States

Location

FutureSearch Trials of Dallas, LLP

Dallas, Texas, 75231, United States

Location

Houston Clinical Trials

Houston, Texas, 77098, United States

Location

Family Psychiatry of the Woodlands

The Woodlands, Texas, 77381, United States

Location

Ericksen Research & Development

Clinton, Utah, 84015, United States

Location

Northwest Clinical Trials

Bellevue, Washington, 98007, United States

Location

Related Publications (2)

• Schein J, Cloutier M, Gauthier-Loiselle M, Catillon M, Xu C, Chan D, Childress A. Assessment of centanafadine in adults with attention-deficit/hyperactivity disorder: A matching-adjusted indirect comparison vs lisdexamfetamine dimesylate, atomoxetine hydrochloride, and viloxazine extended-release. J Manag Care Spec Pharm. 2024 Jun;30(6):528-540. doi: 10.18553/jmcp.2024.30.6.528.

  PMID: 38824626 DERIVED

• Nasser A, Hull JT, Chaturvedi SA, Liranso T, Odebo O, Kosheleff AR, Fry N, Cutler AJ, Rubin J, Schwabe S, Childress A. A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2022 Aug;36(8):897-915. doi: 10.1007/s40263-022-00938-w. Epub 2022 Jul 27.

  PMID: 35896943 DERIVED

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 Hull, Ph.D., Director Clinical research
• Organization: Supernus

jhull@supernus.com

240-403-5324

Study Officials

• Jonathan Rubin, MD

  Chief Medical Officer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 11, 2019
• Study Start: November 20, 2019
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: July 12, 2022
• Results First Posted: July 12, 2022

Record last verified: 2022-06

Locations

US (37)