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Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

NCT03260205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2021-06-08

Study results available
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Summary

The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

Placebo

Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.

DRUG

SPD489 (Lisdexamfetamine dimesylate)

SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.

DRUG

SPD489

SPD489

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2018-10-23
Completion
2018-10-23
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 NCT03260205 on ClinicalTrials.gov