Attention Deficit/Hyperactivity Disorder (ADHD) MedDRA version: 14.1 Level: PT Classification code 10003736 Term: Attention deficit/hyperactivity disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Lisdexamfetamine dimesylate (LDX)
Product Code: SPD489
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: lisdexamfetamine dimesylate
Sponsors
Shire Pharmaceutical Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has had an historical or current inadequate response to MPH treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative 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 greater than or equal to 28 at the Baseline Visit (Visit 0). Are the trial subjects under 18? yes Number of subjects for this age range: 262 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subject has taken >1 MPH treatment (for example, greater than or equal to 2 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, less than or equal to 4 weeks) with an adequate response. • In the investigators 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 or more MPH treatment. • 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. Comorbid psychiatric diagnoses will be established using the Kiddie Schedule for Affective Disorders-Present and Lifetime (K SADS-PL) diagnostic interview at screening, and additional modules if warranted by the results of the initial interview. Subjects may continue participating in behavioural therapy during this study as long as they have been receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0). • Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary • Other safety exclusions based on the known safety profile of the investigational medicinal products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Weekly at each visit;Main Objective: The primary objective of this study is to compare the time to response of lisdexamfetamine dimesylate (SPD489) with that of atomoxetine hydrochloride (STRATTERA) in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate (MPH) treatment where inadequate response includes, but is not limited to, the presence of some residual symptoms, inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative treatment to MPH therapy. The primary efficacy measure is time to response; where individual subject response is assessed using the Clinical Global Impressions – Global Improvement (CGI-I) Scale.; Secondary Objective: 1.To evaluate the efficacy of SPD489 compared to STRATTERA on other secondary efficacy outcomes, including the proportion of responders (assessed using the CGI-I) and improvements on the ADHD-RS-IV. 2.To assess the changes in the core symptoms of ADHD and changes in functional outcomes as measured by the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P). 3.To assess the impact of SPD489 compared to STRATTERA on the perception of health state preferences using the Health Utilities Index – Mark 2 (HUI-2). 4.To evaluate the safety of SPD489 based on incidence of treatment-emergent adverse events (TEAEs), specific evaluation of blood pressure and pulse, electrocardiogram results, and physical examination findings. 5.To monitor subject safety based on responses to the Brief Psychiatric Rating Scale for Children (BPRS-C), Columbia-Suicide Severity Rating Scale (C-SSRS) and the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin). ; Primary end point(s): The primary efficacy endpoint for each subject is the tim | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of responders at each double-blind visit (assessed using the CGI-I) • The change from Baseline (Visit 0) in the ADHD-RS-IV total score at each double-blind visit • The Clinical Global Impressions – Severity of Illness (CGI-S) at Visit 9/ET • The WFIRS-P at Visit 9/ET • The HUI-2 at Visit 4 and Visit 9/ET. TEAES, vital signs, ECG results & physical examination findings will be utilized to assesss the safety and tolerability of SPD489 and Strattera. Subject safety will also be monitored base on responses to the BPRS-C, C-SSRS, and UKU-SERS-Clin Rating Scales. ; Timepoint(s) of evaluation of this end point: • The proportion of responders at each double-blind visit (assessed using the CGI-I) - weekly (Visits 0-9) • The change from Baseline (Visit 0) in the ADHD-RS-IV total score at each double-blind visit - weekly (Visits 0-9) • The Clinical Global Impressions – Severity of Illness (CGI-S) at Visit 9 (week 9) or ET (early termnination) • The WFIRS-P at Visit 9 (week 9) or ET (early termination) • The HUI-2 at Visit 4 (week 4) and Visit 9 (week 9) or ET (early termination) TEAES (visits 0-9), vital signs (visits 0-9), ECG results (Visit 4) & physical examination findings (visit 0 & visit 9) Subject safety will also be monitored base on responses to the BPRS-C,(visits 0, 4, & 9) C-SSRS (visits 0-9), and UKU-SERS-Clin Rating Scales (visits 0-9). | — |
Countries
Belgium, Canada, France, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom, United States
Outcome results
None listed