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

NCT02633527 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2021-10-27

Study results available
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Summary

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.

Conditions

  • Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

DRUG

Placebo

Placebo was administered once daily

DRUG

100mg SPN-812

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

DRUG

200mg SPN-812

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

DRUG

300mg SPN-812

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

DRUG

400mg SPN-812

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

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph T. Hull, PhD · Supernus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2016-07-25
Completion
2016-07-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633527 on ClinicalTrials.gov