A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel Group Study to Assess the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy

Shire64 sites in 5 countries267 target enrollmentJune 28, 2010

ConditionsAttention-Deficit/Hyperactivity Disorder

InterventionsLisdexamfetamine Dimesylate Atomoxetine Hydrochloride

DrugsLisdexamfetamine Dimesylate Atomoxetine Hydrochloride

Overview

Phase: Phase 3
Intervention: Lisdexamfetamine Dimesylate
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: Shire
Enrollment: 267
Locations: 64
Primary Endpoint: Time to First Response
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

Registry

clinicaltrials.gov

Start Date

June 28, 2010

End Date

July 19, 2012

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative drug treatment to MPH therapy.
•Subject is a male or female aged 6-17 years inclusive at the time of consent
•Subject must meet 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 must have a baseline ADHD-RS-IV total score 28.

Exclusion Criteria

•Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, £4 weeks) with an adequate response
•In the Investigator's judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms.
•Subject has previously been exposed to STRATTERA or to amphetamine therapy
•Subject has previously demonstrated intolerable side effects to 1 MPH treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy
•Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments.
•Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.

Arms & Interventions

Lisdexamfetamine Dimesylate

Intervention: Lisdexamfetamine Dimesylate

Atomoxetine Hydrochloride

Intervention: Atomoxetine Hydrochloride

Outcomes

Primary Outcomes

Time to First Response

Time Frame: 9 weeks

Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

Secondary Outcomes

Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks(Baseline and up to 9 weeks)
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)(9 weeks)
Columbia-Suicide Severity Rating Scale (C-SSRS)(9 weeks)
Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1(9 weeks)
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF(Baseline and 9 weeks)
Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks(up to 9 weeks)
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks(Baseline and up to 9 weeks)