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Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT04016779•Supernus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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).

Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, 2-arm, parallel-group, flexible dose trial assessing the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) as monotherapy for the treatment of adults 18-65 years old with Attention-Deficit/Hyperactivity Disorder (ADHD).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 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).
•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:
+8 more criteria

Exclusion Criteria

•1. Has previously enrolled in a SPN-812 study.
•2. Is currently participating in another clinical trial or has participated in a clinical trial within 60 days prior to the first Screening Visit.
•3. 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.
•4. 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.
•5. Has history of severe drug allergy or hypersensitivity, or known hypersensitivity, to the study medication or excipients.
•6. 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:
•1. A current diagnosis of a major neurological disorder; or
•2. Seizures, seizure disorder or seizure-like events; or a history of seizure disorder within the immediate family (siblings, parents); or
•3. Encephalopathy
•7. 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.
+48 more criteria

Locations (37)

Collaborative Neuroscience Network

Garden Grove, California, United States

Pharmacology Research Institute

Los Alamitos, California, United States

Pharmacology Research Institute

Newport Beach, California, United States

Artemis Research Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Artemis Institute for Clinical Research

San Marcos, California, United States

Collaborative Neuroscience Network LLC

Torrance, California, United States

Gulfcoast Research Center

Fort Myers, Florida, United States

Research Centers of America

Hollywood, Florida, United States

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, United States

Key Dates

Start Date

November 20, 2019

Primary Completion Date

October 10, 2020

Completion Date

October 10, 2020

Last Updated

July 12, 2022

Enrollment

374

ACTUAL participants

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

Placebo

DRUG

SPN-812

DRUG

The ADHD Kids´ Study for Children 9-12 Years of Age

NCT07379359

Attention-Deficit/Hyperactivity Disorder (ADHD)

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COMPLETEDPHASE2

Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD

NCT02633527

Attention-Deficit/Hyperactivity Disorder (ADHD)

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WITHDRAWN

A Naturalistic Prospective Study of Treatment Effectiveness for Attention-Deficit/Hyperactivity Disorder (ADHD)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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