Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder
Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention-deficit/Hyperactivity Disorder
Intervention: SPD489 (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Shire Official(s) and/or principal investigator(s): Glen Frick, MD, PhD, Study Director, Affiliation: Shire
Overall contact: Shire Call Center, Phone: +1 866-842-5335
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of patients with treatment-emergent adverse events (TEAEs) in subjects in Group ANumber of patients with treatment-emergent adverse events (TEAEs) in subjects in Group B Change in sleep patterns assessed by questionnaire in subjects in group A Change in sleep patterns assessed by questionnaire in subjects in group B Change in Electrocardiogram (ECG) Results in subjects in Group A Change in Electrocardiogram (ECG) Results in subjects in Group B Change in suicide related behavior assessed by questionnaire in subjects in Group A Change in suicide related behavior assessed by questionnaire in subjects in Group B
Secondary outcome: Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in subjects in Group APercentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in subjects in Group B Change in the clinician-administered Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Preschool Version total score in subjects in Group A Change in the clinician-administered Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Preschool Version total score in subjects in Group B
Eligibility
Minimum age: 4 Years.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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 and Contacts
Shire Call Center, Phone: +1 866-842-5335 Additional Information
Starting date: July 2015
Last updated: June 8, 2015
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