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KP415 Classroom Study in Children (6-12 Years of Age) With ADHD

NCT03292952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2021-06-30

Study results available
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Summary

The study is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy laboratory classroom study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

  • ADHD

Interventions

DRUG

KP415 oral capsule

Daily dose

DRUG

Placebo oral capsule

Daily dose

Sponsors & Collaborators

  • Zevra Therapeutics

    lead INDUSTRY

Principal Investigators

  • Scott H Kollins, PhD · Duke Clinical Research Institute

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
2017-12-20
Primary Completion
2018-05-16
Completion
2018-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03292952 on ClinicalTrials.gov