Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17
Condition: ADHD
Intervention: Lisdexamfetamine dimesylate (LDX); Placebo
Intervention description: LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods); Placebo capsule once per day (double-blind period)
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after
      administered to children and adolescents aged 6-17 with ADHD for at least 6 months
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject's parent or legally authorised 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
             International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline
             E6 and applicable regulations before completing any study-related procedures.

          2. Subject and parent/LAR are willing and able to comply with all the testing and
             requirements defined in this protocol, including oversight of morning dosing.
             Specifically, the parent/LAR must be available upon awakening, at approximately
             7:00AM, to dispense the dose of test product for the duration of the study.

          3. Subject is a male or female aged 6-17 years inclusive at the time of consent for the
             antecedent study (SPD489-325).

          4. Subject satisfied all entry criteria for the antecedent study (SPD489-325), and
             completed a minimum of 4 weeks of double-blind treatment, reached Visit 4 and
             completed the 1-week post-treatment washout in the antecedent study (SPD489-325),
             without experiencing any clinically significant AEs that would preclude exposure to
             LDX.

          5. Subject must have a satisfactory medical assessment with no clinically significant or
             relevant abnormalities as determined by medical history, physical examination findings
             and clinical laboratory test results.

          6. Subject has blood pressure measurements within the 95th percentile for age, gender,
             and height.

        Exclusion Criteria:

          1. Subject was terminated from SPD489-325 for non-compliance and/or experienced an SAE or
             AE resulting in termination from the antecedent study.

          2. 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 (such as Post Traumatic Stress Disorder,
             psychosis, bipolar illness, pervasive developmental disorder, severe obsessive
             compulsive disorder, severe depressive or severe anxiety disorder) or other
             symptomatic manifestations, such as agitated states, marked anxiety, or tension that,
             in the opinion of the examining clinician, will contraindicate treatment with LDX or
             confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be
             established at the Screening Visit (Visit -1)of the antecedent study (SPD489-325)with
             the Screening interview of the Kiddie-SADS-Present and Lifetime-Diagnostic Interview
             (K-SADS-PL)and additional modules if warranted by the results of the initial
             interview. Participation in behavioural therapy is permitted provided the subject was
             receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0)
             of the antecedent study (SPD489-325).

          3. Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.

          4. Subject has any concurrent chronic or acute illness or unstable medical condition that
             could confound the results of safety assessments, increase risk to the subject or lead
             to difficulty complying with the protocol.

          5. Subject is currently considered a suicide risk, has previously made a suicide attempt
             or has a prior history of, or is currently, demonstrating active suicidal ideation.

          6. Subject is female and is pregnant or lactating.

          7. Subject has glaucoma.

          8. Subject has any clinically significant ECG at Visit 8 of the antecedent study
             (SPD489-325) or clinically significant laboratory abnormalities at Visit 7 of the
             antecedent study (SPD489-325).

          9. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine.

         10. Subject has a recent history (within the past 6 months) of suspected substance abuse
             or dependence disorder (excluding nicotine)in accordance with the Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition - Text Revision
             (DSM-IV-TR)criteria.

         11. Subject has a history of seizures (other than infantile febrile seizures), a tic
             disorder, a current diagnosis and or a known family history of Tourette's Disorder.

         12. 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 them at increased vulnerability to the sympathomimetic effects of a stimulant
             drug.

         13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

         14. Subject is taking any medication that is excluded.

         15. Subject is taking other medications that have central nervous system (CNS) effects,
             affect performance, such as sedating antihistamines and decongestant sympathomimetics,
             or are monoamine oxidase inhibitors (during or within 14 days of investigational
             medicinal product administration). Stable use of bronchodilator inhalers is not
             exclusionary.

         16. Subject has a documented allergy, hypersensitivity, or intolerance to any excipients
             in the investigational medicinal product(s).