A phase III, randomized, double blind, multicenter, parallel group, placebo and active controlled, dose optimization safety and efficacy study of Lisdexamfetamine Dimesylate (LDX) in children and adolescent aged 6-17 with attention-deficit/hyperactivity disorder (ADHD)

• Conditions: Attention Deficit/Hyperactivity Disorder ADHD; MedDRA version: 14.1Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2008-000679-90-IT
• Lead Sponsor: Shire Pharmaceutical Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-20
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Subject s parent or legally authorised representative (LAR) shall sign the informed consent, and documentation of assent (if applicable) is required by the subject indicating that the subject is aware of the investigational nature of the study and of the required procedures and restrictions, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations before performing any study-related procedures. 2. Subject and parent/LAR must be willing and able to comply with all the tests and requirements defined in this protocol, including supervision of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00AM, to dispense the dose of study drug for the duration of the study. 3. Subject is a male or female aged 6-17 years inclusive at the time of consent. 4. 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. 5. Subject must have a Baseline ADHD-RS-IV total score 28. 6. Female subjects of childbearing potential (FOCP), must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and must agree to comply with any applicable contraceptive requirements of the protocol. 7. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline. 8. Subject has an age-appropriate intellectual level, as deemed by the study investigator. 9. Subject is able to swallow a capsule.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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

1. Subject has failed to respond to more than one adequate regimen (dose and duration) of stimulant treatment. One regimen must have been a long-acting formulation. 2. Subject has a current, controlled (requiring a restricted treatment) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, anorexia nervosa, severe depressive or severe anxiety disorder) or other symptomatic manifestations, such as agitation states, marked anxiety, or tension that, in the opinion of the examining physician, contraindicate treatment with LDX or CONCERTA XL or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established with the Screening interview of the Kiddie-SADS-Present and Lifetime Diagnostic Interview (K SADS-PL) and additional modules if required by the results of the initial interview. Subjects may continue participating in behavioural therapy during this study as long in the case of being included in the program since at least 1 month at the time of the Baseline Visit. 3. Subject has a conduct disorder. Oppositional Defiant Disorder is not an exclusion cause . 4. Subject has a concomitant chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might interfere with the results of safety assessments conducted in the study or that might increase risks for the subject. Similarly, the subject will be excluded if he or she has any additional condition that, in the Investigator s opinion, might prohibit the subject from completing the study or would not be convenient for the subject. Additional conditions include any significant disease or unstable medical condition that might lead to difficulties in complying with the protocol. Mild, stable asthma is not an exclusion cause . 5. Subject is currently considered at suicide risk, has previously made a suicide attempt or has a prior history of, or has currently, active suicidal intentions . 6. Subject is female and is pregnant or lactating. 7. Subject has glaucoma. 8. Subject weight is below 22.7kg (50lbs). 9. Subject is significantly overweight (defined as a BMI >97th percentile) based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. 10. Subject is positive at urine drug Screening analysis (with the exception of subject s current ADHD treatment). 11. Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) at Screening. Treatment with a stable dose of thyroid drug for at least 3 months is permitted. 12. Subject has clinically significant laboratory or ECG abnormalities at Screening and/or Baseline. 13. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate. 14. Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the investigational or comparison product. 15. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in compliance with DSM-IV-TR criteria.16. Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or acurrent dia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified