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Classroom Study of SPN-812 in Children With ADHD

NCT04016792 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-09-18

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of SPN-812, an extended-release formulation of viloxazine, compared to placebo in children in an analog classroom setting.

Conditions

  • ADHD

Interventions

DRUG

Placebo

Placebo will be administered once daily

DRUG

200 mg SPN-812

200 mg SPN-812 will be administered once daily and compared to Placebo

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stefan Schwabe, MD · Chief Medical Officer

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
2019-08-31
Primary Completion
2020-09-30
Completion
2020-11-30
FDA Drug
Yes

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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 NCT04016792 on ClinicalTrials.gov