Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD

NCT04786990 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 812P412
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 17

Brief Summary

This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events During 8 Weeks of Adjunct SPN-812 Treatment

  The percent of subjects who took at least one dose of SPN-812 and reported at least one adverse event during 8 weeks of adjunct SPN-812 Treatment. 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 then multiplying the product by 100. The higher the percent, the higher the incidence.

  Weeks 1-8

Secondary Outcomes (31)

• Incidence of Adverse Events During Adjunctive SPN-812 Treatment During Weeks 1-4 (SPN-812 Dosed in Morning Hours [AM Dosing]) and During Weeks 5-8 (SPN-812 Dosed in Evening Hours [PM Dosing])

  Weeks 1-4 and Weeks 5-8

• Change From Baseline in the Investigator-rated Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (IR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)

  Baseline, Week 4, and Week 8

• Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)

  Baseline, Week 4, and Week 8

• Clinical Global Impression-Improvement (CGI-I) Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)

  Week 4 and Week 8

• Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)

  Baseline, Week 4, and Week 8

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule) Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)

Drug: SPN-812

Interventions

SPN-812 DRUG

Viloxazine extended-release capsule

Open-Label Treatment

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Is male or female, 6 to ≤17 years and 9 months of age at screening.
• Parent(s)/legal guardian(s) is able to read and understand the Informed Consent Form (ICF).
• Written informed consent obtained by parent(s)/legal guardian(s) and informed assent obtained from the subject, if applicable.
• Subject and parent(s)/legal guardian(s) are willing and able to comply with all of the procedures and requirements defined in the protocol, including parents(s)/legal guardian(s) oversight of morning and evening dosing of the SPN-812 and recording a daily medication/dosing diary for psychostimulant and/or SPN-812 during the study.
• Has lived with the same parent(s)/legal guardian(s) at same residence for at least the last 6 months prior to screening.
• Has a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at screening.
• Is currently and expecting to continue and remain on a stable psychostimulant regimen throughout the study. A stable stimulant regimen is defined as taking dose at least 5 days per week (morning), no significant change in dose or dosing frequency at least 2 weeks prior to baseline (Visit 2), and the investigator believes the subject's psychostimulant dose is optimized.
• Is functioning at an age-appropriate level intellectually, as judged by the Investigator.
• Is a child (6-11 years of age) with a body weight of at least 20 kg at screening or is an adolescent (12-17 years of age) with a body weight of at least 35 kg at screening.
• Has a resting (sitting) blood pressure (BP) and resting pulse rate measurement within the 95th percentile for age, sex, and height.
• Is considered medically healthy by the Investigator via assessment of physical examination, medical and psychiatric histories, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
• Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the following acceptable, highly effective contraceptive methods beginning/during the screening period prior to the first dose of SM and throughout the study:
• Simultaneous use of male condom and intra-uterine contraceptive device placed during screening period prior to first dose of SM
• Surgically sterile male partner (e.g., vasectomized partner is sole partner)
• Barrier method: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

You may not qualify if:

• Is currently participating in another clinical trial or has participated in a clinical trial within 60 days prior to screening.
• 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.
• Is a female subject who is pregnant, lactating and/or sexually active and not agreeing to use one of the acceptable contraceptive methods throughout the study.
• Has history of severe drug allergy or hypersensitivity, or known hypersensitivity, to the study medication (SPN-812).
• 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;
• seizures, seizure disorder or seizure-like events;
• history of seizure disorder within the immediate family (siblings, parents); or
• encephalopathy
• a history of mild social anxiety disorder or generalized anxiety disorder according to DSM-5 criteria;
• a history of mild to moderate ODD according to DSM-5 criteria;
• a history of Major Depressive Disorder, if he/she has not experienced a major depressive disorder episode or required psychiatric counselling; or pharmacotherapy within the 6 months prior to screening
• Has a known history of physical, sexual, or emotional abuse in the last year prior to screening.
• Has any other disorder for which its treatment takes priority over treatment of ADHD or is likely to interfere with study treatment, impair treatment compliance, or interfere with interpretation of study results.
• Has a current diagnosis of drug abuse or dependence disorder within the 12 months prior to screening, has a history of drug abuse or dependence disorder or has an immediate family member living at study participant's' home who has current diagnosis drug abuse or dependence disorder (per DSM-5 criteria).

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (17)

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

APG Research, LLC

Orlando, Florida, 32803, United States

Location

Elite Clinical Trials

Blackfoot, Idaho, 83221, United States

Location

Elite Clinical Trials

Rexburg, Idaho, 83440, United States

Location

Qualmedica Research, LLC

Evansville, Indiana, 47715, United States

Location

Psychiatric Associates Purehealth Medical Center

Overland Park, Kansas, 66221, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Alivation Research, LLC

Lincoln, Nebraska, 68526, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

SP Research, PLLC

Oklahoma City, Oklahoma, 73112, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Gadolin Research, LLC

Beaumont, Texas, 77702, United States

Location

Family Psychiatry of The Woodlands

The Woodlands, Texas, 77381, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Barbara Diaz Hernandez MD Research, INC.

San Juan, 00926, Puerto Rico

Location

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 T. Hull, PhD
• Organization: Supernus Pharmaceuticals

jhull@supernus.com

240-403-5324

Study Officials

• Jonathan Rubin, MD, MBA

  Chief Medical Officer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: July 27, 2021
• Primary Completion: May 23, 2023
• Study Completion: July 26, 2023
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Locations

US (16); PR (1)