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Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD

NCT03247530 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2021-07-02

Study results available
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Summary

This study will evaluate the efficacy and safety of low doses of SPN-812 in children 6-11 years of age diagnosed with ADHD.

Conditions

  • 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

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stefan Schwabe, MD · Supernus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2018-09-12
Completion
2018-09-12
FDA Drug
Yes

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 NCT03247530 on ClinicalTrials.gov