Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
Condition: ADHD
Intervention: Lisdexamfetamine Dimesylate (LDX)
Intervention description: optimal dose of 30, 50 or 70 mg once daily
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the long-term safety of LDX administered
      as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years
      of age inclusive at the time of consent).
    

Eligibility criteria:

        Inclusion

          1. Subject is a male or female aged 13-17 years inclusive at the time of consent of the
             antecedent study (SPD489-305).

          2. Subject satisfied all entry criteria for the antecedent study (SPD489-305), and
             completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the
             antecedent study (SPD489-305), without experiencing any clinically significant adverse
             events (AEs) that would preclude exposure to LDX.

        Exclusion

          1. Subject was terminated from SPD489-305 for non-compliance and/or experienced a serious
             adverse event (SAE) or AE resulting in termination from the antecedent study
             (SPD489-305).

          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 (SPD489-305)
             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 behavioral therapy, 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 (SPD489-305).

          3. Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.

          4. Subject is currently considered a suicide risk, has previously made a suicide attempt
             or has a prior history of, or is currently demonstrating suicidal ideation.

          5. Subject is underweight based on Center for Disease Control and Prevention Body Mass
             Index (BMI)-for-age gender specific charts at the Enrollment Visit (Visit 1) of this
             study. Underweight is defined as a BMI < 5th percentile.

          6. Subject has a 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.

          7. Subject has a history of seizures (other than infantile febrile seizures), any tic
             disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.

          8. Subject has a known history 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.

          9. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

         10. Subject has any clinically significant ECG, based on the Principal Investigator's
             judgment, at Visit 4/ET of the antecedent study (SPD489-305).

         11. Subject is taking any medication that is excluded.

         12. Subject has a documented allergy, hypersensitivity or intolerance to amphetamine.

         13. Subject has a recent history (within the past 6 months) of suspected substance abuse
             or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.

         14. Subject has glaucoma.

         15. Subject is taking other medications that have central nervous system (CNS) effects or
             affect performance, such as sedating antihistamines and decongestant sympathomimetics,
             or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not
             exclusionary.

         16. Subject is female and is pregnant or lactating.