MedDataX Logo

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

NCT ID: NCT02633527

Last Updated: 2021-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2016-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo, qd, oral capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo was administered once daily

100mg SPN-812

100mg SPN-812, qd, oral capsule

Group Type EXPERIMENTAL

100mg SPN-812

Intervention Type DRUG

100mg SPN-812 was administered once daily and compared to placebo

200mg SPN-812

200mg SPN-812, qd, oral capsule

Group Type EXPERIMENTAL

200mg SPN-812

Intervention Type DRUG

200mg SPN-812 was administered once daily and compared to placebo

300mg SPN-812

300mg SPN-812, qd, oral capsule

Group Type EXPERIMENTAL

300mg SPN-812

Intervention Type DRUG

300mg SPN-812 was administered once daily and compared to placebo

400mg SPN-812

400mg SPN-812, qd, oral capsule

Group Type EXPERIMENTAL

400mg SPN-812

Intervention Type DRUG

400mg SPN-812 was administered once daily and compared to placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placebo was administered once daily

Intervention Type DRUG

100mg SPN-812

100mg SPN-812 was administered once daily and compared to placebo

Intervention Type DRUG

200mg SPN-812

200mg SPN-812 was administered once daily and compared to placebo

Intervention Type DRUG

300mg SPN-812

300mg SPN-812 was administered once daily and compared to placebo

Intervention Type DRUG

400mg SPN-812

400mg SPN-812 was administered once daily and compared to placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PBO SPN-812, Low Dose SPN-812, Low-Medium Dose SPN-812, Medium-High Dose SPN-812, High Dose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
3. CGI-S score of at least 4
4. Weight of at least 20 kg.
5. Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

Exclusion Criteria

1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
3. Significant systemic disease.
4. Evidence of suicidality within the six months before Screening or at Screening.
5. BMI greater than 95th percentile for the appropriate age and gender.
6. Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
7. Substance or alcohol use during the last three months.
8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph T. Hull, PhD

Role: STUDY_DIRECTOR

Supernus Pharmaceuticals, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florida Clinical Research Center, LLC

Maitland, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

812P202

Identifier Type: -

Identifier Source: org_study_id