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Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder

NCT02466386 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2021-03-05

Study results available
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Summary

The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

SPD489

Participants will receive 5 mg of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Shire Physician · Shire

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-08-21
Primary Completion
2020-01-03
Completion
2020-01-03
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 NCT02466386 on ClinicalTrials.gov