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Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT01101022 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2021-06-09

Study results available
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Summary

The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.

Conditions

  • ADHD Specifically With Executive Function Impairment

Interventions

DRUG

SPD489

1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks)

OTHER

Placebo

1 capsule per day, daily throughout the double-blind treatment period (10 weeks)

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-19
Primary Completion
2010-11-29
Completion
2010-11-29

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 NCT01101022 on ClinicalTrials.gov