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

NCT04143217 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 812P311
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 38

Brief Summary

Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 in adult ADHD patients

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  The percent of subjects who took at least one dose of SPN-812 (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population

  Up to 156 weeks

Secondary Outcomes (33)

• The Effect of SPN-812 on Overall ADHD Symptoms as Measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS)

  Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124

• The Effect of SPN-812 on Global Assessment of ADHD Symptom Severity as Measured by the Clinical Global Impression - Severity of Illness (CGI-S)

  Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124

• The Effect of SPN-812 on Clinical Global Impression - Severity of Illness (CGI-S) Responder Rate

  Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124

• The Effect of SPN-812 on Global Assessment of Improvement of ADHD Symptoms as Measured by the Clinical Global Impression - Improvement Scale (CGI-I) Scale

  Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124

• The Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Responder Rate

  Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

SPN-812 Open-Label Treatment 200mg to 600mg SPN-812 once daily for up to 156 weeks

Drug: SPN-812

Interventions

SPN-812 DRUG

SPN-812 200 to 600 mg/day

Also known as: viloxazine extended-release capsules (Qelbree)

Open-Label Treatment

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 a male or female who completed Study 812P306 and opts/consents to participate in the study if approved by PI.
• Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs), in the opinion of the Investigator, assessed at Visit 1.
• Is able to read and understand the Informed Consent Form (ICF).
• Has signed the ICF.
• Is willing and able to attend study appointments within specified time windows.
• Is a female of childbearing potential (FOCP) who is either sexually inactive (abstinent) or, if sexually active, agrees to use one of the following acceptable birth control methods beginning at least 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 their Visit 1).
• Is a male who:
• Agrees to use 2 methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from Visit 1 to ≥ 1 month after the last dose of SM, OR
• Has been surgically sterilized prior to Visit 1.

You may not qualify if:

• Is currently participating in another clinical trial other than Study 812P306.
• Has any current psychiatric disorder per Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (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.
• Current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders.
• Current evidence of suicidality (suicidal thoughts or behaviors).
• 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 a positive result on urine drug screen at Visit 1.
• Use of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) at the Visit 1 for the duration of the study.
• Has a clinical laboratory value, vital sign value or ECG result at Visit 1 that is considered to be clinically significant in the opinion of the Investigator.
• Has one or more clinical laboratory test values outside the reference range at Visit 1 that, in the opinion of the Investigator, are clinically significant, or any of the following (see Note below):
• Serum creatinine \> 1.5 times the upper limit of normal (ULN);
• Serum total bilirubin \> 1.5 times ULN;
• Serum alanine aminotransferase or aspartate aminotransferase \> 2 times ULN.
• Has any of the following cardiology findings at Visit 1 (see Note below):
• Abnormal ECG that is, in the Investigator's opinion, clinically significant;
• PR interval \> 220 ms;

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (38)

South California Research LLC

Beverly Hills, California, 90210, United States

Location

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 Institue 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 Rearch

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

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, 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

Clinical Neuroscience Solutions

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

Northwest Clinical Trials

Bellevue, Washington, 98007, United States

Location

Related Publications (1)

• Childress A, Cutler AJ, Adler LA, Fry N, Asubonteng K, Maldonado-Cruz Z, Formella A, Rubin J. An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2024 Nov;38(11):891-907. doi: 10.1007/s40263-024-01120-0. Epub 2024 Oct 7.

  PMID: 39373844 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: Jonathan Rubin, MD, MBA, Senior Vice President/Chief Medical Officer
• Organization: Supernus Pharmaceuticals Inc.

jrubin@supernus.com

240-403-5710

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: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: January 23, 2020
• Primary Completion: July 26, 2022
• Study Completion: December 14, 2022
• Last Updated: February 13, 2024
• Results First Posted: February 13, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)