Trial Information

Summary: This is a prospective, open-label, multi-center, dose-optimization, Phase IIIb study designed to evaluate an investigational drug in children aged 6-12 who have been diagnosed with ADHD

If your child has school problems he or she may have ADHD "ATTENTION DEFICIT HYPERACTIVE DISORDER".

Amedica Research Institute and Dr. Marino Molina, Child and Adolescent Psychiatrist and ADHD Specialist, are conducting a 9-week research study of a study-related medication for Attention Deficit Hyperactive Disorder in children 6-12 years old.

If you believe your child suffers from ADHD, he or she may qualify for this research study of ADHD.

Qualified participants will receive study related

• Evaluations
• Medical Test
• Medication
• Doctor Visit
• Compensation for time and travel

For information about this ADHD research study, please cal (305)- 681-7789.

Patient Inclusion Criteria:

• Subject's parent or legally authorized representative must provide signature of informed consent, and there must be documentation of assent by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions
• Subject is male or female aged 6-12 years inclusive at the time of consent
• Females of childbearing potential must have a negative serum beta Human Chronic Gonadotropin pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol
• Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, 4th ed. - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation
• Subjects must have a baseline ADHD-RS-IV total score greater than or equal to 28
• Subject is functioning at an age-appropriate level intellectually, as deemed by the study investigator
• Subject and parent/legally authorized representative are willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing. Specifically, the parent/legally-authorized representative must be available upon awakening, at approximately 7:00 am, to dispense the dose of Vyvanse for the duration of the study
• Subject is able to swallow a capsule
• Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and/or Baseline

Patient Exclusion Criteria:

• Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders (such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive development disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining physician, will contraindicate treatment with Vyvanse or confound efficacy or safety assessments. Comorbid psychiatric diagnosis will be established 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. Subjects may continue participating in a behavior modification program during this study as long as they have been participating in the program for at least a month at the time of Baseline visit
• Subject has Conduct Disorder
• Subject has documented allergy, hypersensitivity, or intolerance to amphetamines
• Subject has failed to respond to one or more adequate course (dose and duration) of amphetamine therapy
• The 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
• Subject weighs less then 50 pounds
• Subject is significantly overweight based on Body Mass Index (BMI-for-age >95th percentile) per CDC BMI-for-age gender specific charts
• Subjects has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder
• Subject has any reported history of abnormal thyroid function
• Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening
• Subject has any clinically significant ECG or laboratory abnormalities at Screening and/or Baseline
• Subject has a known history of structural cardiac abnormality, as well as any other condition(s) that effect cardiac performance
• 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 administered 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. This would include any significant illness or unstable medical condition that can lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary
• Subject is taking any medication that is excluded
• Subject is taking other medications that have Central Nervous System (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics (bronchodilators are not exclusionary)
• The female subject is pregnant or lactating
• Subject is well-controlled on their current ADHD medication with acceptable tolerability
• Subject is related to a member of the study staff

For More Information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.