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Summary

for people ages 4–5 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

To evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD). Subjects will be enrolled into this study from antecedent study SPD489-211 (NCT02402166) or SPD489-347.

Official Title

A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed With Attention-deficit / Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder (ADHD) Disease Attention Deficit Disorder with Hyperactivity Hyperkinesis Lisdexamfetamine Dimesylate

Eligibility

You can join if…

Open to people ages 4–5

  1. Subject is male or female aged 4-5 years inclusive at the time of consent for an antecedent SPD489 trial in the preschool ADHD population.
  2. For "A" Subjects: Subject is on a known dose of SPD489 and completed the final visit of the treatment phase of an unblinded antecedent study without experiencing any clinically significant AEs that would preclude exposure to SPD489 and can directly enter this study without gap between the antecedent study and this study (defined as≤3 days since last dose in the prior study), OR For "B" Subjects: Subject requires dose titration and completed at least the dose optimization and follow up of a blinded antecedent study without experiencing any clinically significant AEs that would preclude exposure to SPD489, OR For "B" Subjects: Subject completed the final visit of the treatment phase of an unblended antecedent study without experiencing any clinically significant AEs that would preclude exposure to SPD489, and did not enroll in this study within 3 days (i.e., >3 days since last dose in the prior study).
  3. Subject's parent or 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 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 same parent/LAR should be available to dispense the dose of investigational product for the study duration.
  5. For "A" Subjects: Subject has a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by physical examination findings or vital sign results that would preclude treatment with SPD489. For "B" Subjects:Subject has a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by physical examination findings clinical laboratory test results, ECG results, or vital sign results that would preclude treatment with SPD489.
  6. Subject has lived with the same parent or guardian for >6 months.

You CAN'T join if...

  1. Subject was terminated from an antecedent SPD489 trial for non-compliance and/or experienced a SAE or AE resulting in termination from any previous SPD489 trial.
  2. Subject experienced any clinically significant AEs in any previous SPD489 trial that,in the opinion of the investigator, would preclude further exposure to SPD489.
  3. Subject is required to or anticipates the need to take medications that have central nervous system effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
  4. 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 condition(s) would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
  5. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
  6. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
  7. Subject has a blood pressure measurement > 95th percentile for age, sex, and height at Visit 0.
  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 placing them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
  9. Subject has a current diagnosis of adjustment disorder, autism, psychosis, or bipolar disorder.
  10. . Subject is currently considered at risk for suicide 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.
  11. . Subject has a history of seizures (other than infantile febrile seizures) or a current diagnosis of Tourette's Disorder.
  12. . Subject has a chronic or current tic disorder that is judged by the investigator to be exclusionary
  13. . Subject is taking any medication that is excluded per the protocol.
  14. . For "B" Subjects only: Subject had any clinically significant ECG or clinical laboratory abnormalities at the Screening Visit (Visit -1).
  15. . For "B" Subjects only: Subject has current abnormal thyroid function, defined as abnormal TSH and T4 at the Screening Visit (Visit -1) or Visit 0. Treatment with a stable dose of thyroid medication for at least 3 months is permitted

Locations

  • University of California in progress, not accepting new patients
    San Francisco, California, 94143, United States
  • Asclepes Research in progress, not accepting new patients
    Panorama City, California, 91402, United States
  • Alliance for Wellness d/b/a Alliance for Research in progress, not accepting new patients
    Long Beach, California, 90807, United States
  • AVIDA accepting new patients
    Newport Beach, California, 92660, United States
  • Center For Psychiatry and Behavioral Medicine In accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Elite Clinical Trials, Inc in progress, not accepting new patients
    Wildomar, California, 92595, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shire
ID
NCT02466386
Phase
Phase 3
Study Type
Interventional
Last Updated
November 16, 2017