A Study to assess the safety and efficacy of SPD489 compared with Concerta with a placebo reference arm on patients aged 13-17 years with Attention-Deficit/Hyperactivity Disorder

• Conditions: Attention-deficit/hyperactivity disorder is a psychiatric disorder characterized by developmentally inappropriate degrees of inattentiveness, impulsivity, and hyperactivity; MedDRA version: 16.1Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2011-005452-34-DE
• Lead Sponsor: Shire Development LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-04
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

The subject will not be considered eligible for the study without meeting
all of the inclusion criteria below. The subject cannot be randomized
before all inclusion criteria (including test results) are confirmed.
1. Subject must be 13-17 years of age, inclusive, at the time of consent.
2. Subject must weigh more than 79.5lb (36kg).
3. Subject's parent or legally authorized representative (LAR) must
provide signature of informed consent, and there must be documentation
of assent (if applicable) by the subject indicating that the subject is
aware of the investigational nature of the study and the required
procedures and restrictions in accordance with the ICH Good Clinical
Practice (GCP) Guideline E6 (1996) and applicable regulations before
completing any study-related procedures.
4. Subject and parent/LAR are willing and able to comply with all of the
testing and requirements defined in the protocol, including oversight of
morning dosing. Specifically, the parent/LAR must be available at
approximately 7:00AM (±2 hours) to
dispense the dose of investigational product for the study duration.
5. Subject, who is a female, must not have a positive serum beta human
chorionic gonadotropin (ß-HCG) pregnancy test at the Screening Visit
(Visit -1) and must have a negative urine pregnancy test at the Baseline
Visit (Visit 0) and agree to comply with any applicable contraceptive
requirements of the protocol.
6. Subject meets the DSM-IV-TR criteria for a primary diagnosis of ADHD
based on a detailed psychiatric evaluation.
7. Subject has an ADHD-RS-IV total score =28 at the Baseline Visit (Visit 0).
8. Subject is functioning at an age-appropriate level intellectually, as
determined by the study Investigator.
9. Subject is able to swallow a capsule.
10. Subject's blood pressure measurements do not exceed the 90th
percentile for age, sex, and height at the Screening Visit (Visit -1) and
the Baseline Visit (Visit 0)
11. Subject is not completely satisfied with any aspect of their current
therapy
Are the trial subjects under 18? yes
Number of subjects for this age range: 542
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

Subjects are excluded from the study, if any of the following criteria are met at the Screening
Visit (Visit -1) or at the Baseline Visit (Visit 0).

The complete list of exclusion criteria are available in Section 4.2 of the Protocol

1. 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 VYVANSE or CONCERTA or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit -1) interview of the Kiddie–Schedule for Affective Disorders and Schizophrenia for School age Children–Present and Lifetime Version–Diagnostic Interview (K-SADS-PL) and additional modules if warranted by the results of the initial interview. Subjects may continue participation in a behavioral modification program during the study as long as they have been participating in the program for at least 1 month at the time of the Baseline Visit (Visit 0).
2. Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
3. Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
4. Subject is underweight based on Centers for Disease Control and Prevention (CDC) body mass index (BMI)-for-age sex-specific values at the Screening Visit (Visit -1). Underweight is defined as a BMI <3rd percentile.
5. Subject is significantly overweight based on CDC BMI-for-age sex-specific values at the Screening Visit (Visit -1). Significantly overweight is defined as a BMI >97th percentile for this study.
6. 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. Similarly, the subject will be excluded if he or she has any additional condition(s) that, in the Investigator’s opinion, would prohibit the subject from completing the study or would not be in the best interest of the subject. The additional conditions would include any significant illness or unstable medical condition
that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
7. Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or 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.
8. 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 sympathomim

Study & Design

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