A Phase 3b, Randomized, Double-blind, Multicenter, Placebo Controlled, Dose Optimization, Crossover, Analog Classroom, Safety and Efficacy Study of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD))

Shire6 sites in 1 countryMarch 6, 2011

ConditionsADHD

InterventionsPlacebo SPD489

DrugsSPD489

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: ADHD
Sponsor: Shire
Locations: 6
Primary Endpoint: Permanent Product Measure of Performance (PERMP) Total Score
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom setting based on the Permanent Product Measure of Performance (PERMP) total score assessed across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover period.

Registry

clinicaltrials.gov

Start Date

March 6, 2011

End Date

May 4, 2011

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be male or female, 13-17 years of age inclusive, at the time of consent.
•The parent/LAR must be available at approximately 7:00 AM (±2 hours) to dispense the dose of investigational product for the study duration.
•Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
•Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
•Subject has an Attention Deficit/Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) total score ≥
•Subject is functioning at an age-appropriate level intellectually.
•Subject is able to swallow a capsule.

Exclusion Criteria

•Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining clinician, will contraindicate treatment with SPD489 or confound efficacy or safety assessments.
•Subject has a documented history of aggressive behavior serious enough to preclude participation in regular classroom activities, as determined by the Investigator. Oppositional defiant disorder is not exclusionary.
•Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently, demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator
•Subject is underweight.
•Subject is significantly overweight.
•Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject.
•Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, a current diagnosis, and/or a known family history of Tourette's Disorder. Subject has a history of tics that are judged by the Investigator to be exclusionary.
•Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant drug.
•Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
•Subject has any clinically significant electrocardiogram (ECG) or clinically significant laboratory abnormality.

Arms & Interventions

Placebo

Intervention: Placebo

SPD489

Intervention: SPD489

Outcomes

Primary Outcomes

Permanent Product Measure of Performance (PERMP) Total Score

Time Frame: 7 Days

Secondary Outcomes

Vital Signs (includes oral or tympanic temperature, sitting blood pressure, pulse and respiratory rate) and Body Height and Weight(Baseline, Weeks 7, 14, 21, 28, 35 and 42)
Conners' Parent Rating Scale - Revised (CPRS-R) Total Score(7 Days)
Attention Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score(7 Days)
Clinical Global Impressions - Global Improvement (CGI-I) Rating Scale Score(7 Days)
Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline, Weeks 7, 14, 21, 28, 35 and 42)