Status:
UNKNOWN
Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD
Lead Sponsor:
JPM van Stralen Medicine Professional
Collaborating Sponsors:
Purdue Pharma, Canada
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effect of Foquest® on sleep, using actigraphy and sleep diaries, in children aged 6-12 compared to baseline on no medication. Sleep difficulties, including...
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) is a heterogeneous neurobehavioral disorder characterized by a persistent pattern of developmentally inappropriate inattentiveness, impulsivity, and hyp...
Eligibility Criteria
Inclusion
- Male or female patient aged 6 to 12 years at the time of consent/assent.
- Subject's parent or legally authorized representative (LAR) must be mentally and physically competent to provide informed consent and subject must be competent to provide assent and be able and willing to comply with the study protocol, including the number of visits and study duration.
- Patient meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria for a diagnosis of ADHD combined presentation, inattentive presentation or hyperactive/impulsive presentation based on history.
- Patient has a blood pressure measurement within 95th percentile for age, sex and height.
- Patient and parent (LAR) are willing, able and likely to comply with the study procedures and restrictions within the protocol including wearing an actigraphic wrist device.
Exclusion
- Subject has sleep disorder breathing condition or another sleep disorder that may interfere with the interpretation of the study.
- Subject has any condition that, in the opinion of the investigator, represent an inappropriate risk to the subject or may confound the interpretation of the study including subject being in an agitated state.
- Subject has a true allergy to methylphenidate, history of serious adverse reactions to methylphenidate or be known to be non-responsive to methylphenidate. Non-response is defined as methylphenidate use at various doses for a phase of at least four weeks at each dose with little or no clinical benefit in the past 10 years.
- Subject has a known history or presence of structural cardiac abnormalities, cardiovascular or cerebrovascular disease, serious heart rhythm abnormalities, syncope, tachycardia, cardiac conduction problems (such as clinically significant heart block or QT interval prolongation), exercise-related cardiac events including syncope and pre-syncope, clinically significant bradycardia or moderate to severe hypertension.
- Subject has a history of seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years).
- Subject has glaucoma, hyperthyroidism, thyrotoxicosis, advanced arteriosclerosis, or severe renal insufficiency.
- Females of child-bearing potential (FOCP) who are pregnant, planning on becoming pregnant or breast feeding.
- Subject is currently, or within the past 14 days, receiving MAO inhibitors.
- Subject has a primary diagnosis of bipolar disorder, as assessed at visit.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04741516
Start Date
December 1 2020
End Date
December 31 2023
Last Update
September 28 2023
Active Locations (1)
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1
Center for Pediatric Excellence
Ottawa, Ontario, Canada, K2G1W2