Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD

NCT04741516 | Unknown Phase 4

• 1 other identifier: RES 19-009
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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 prolonged sleep onset latency and decreased total sleep time have a significant negative impact on the functioning of children. In adults, sleep deprivation may result in drowsiness and yawning. However, in children, this may manifest as mood and behavioural disturbances which may even mimic the classic symptoms of ADHD; hyperactivity, poor impulse control, and inattention. This can in turn negatively affect the day to day activities of a child such as social interactions and learning. A meta-analysis in 2015 showed that stimulant medications impair sleep of children and adolescents. Some researchers have argued that stimulant medication may improve sleep. Importantly there appears to be heterogeneity in the effects of stimulant medication on sleep with some people sleeping better and some people worse after taking Foquest®. Although the randomized controlled trials done to date have demonstrated the efficacy and outlined the safety profile of Foquest, there remains some unanswered questions about the practical implications in the real-world setting. Some clinicians have raised the concern, for example, that the extended duration of Foquest, may have a negative impact on sleep. This study will evaluate the effect of Foquest® on sleep and particularly sleep latency and self and parent reported sleep restorative quality. This would be a novel study as there is no objective or subjective data on the effect of the Foquest® on sleep latency and total sleep time in children aged 6-12.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Foquest; Attention Deficit Hyperactivity Disorder; Sleep; Sleep latency

Outcome Measures

Primary Outcomes (1)

• Change in sleep onset latency

  The Sleep Self Report - Child Form (SSR-C) was designed to measure five domains including sleep habits, problems falling asleep, sleep duration, night waking and daytime sleepiness. The wGT3X-BT is ActiGraph's flagship activity monitor, used by researchers around the world to capture and record continuous, high resolution physical activity and sleep/wake information.

  8 weeks

Secondary Outcomes (5)

• Executive Function

  8 weeks

• ADHD Symptoms

  8 weeks

• Severity of Illness

  8 weeks

• Improvements of Subjects

  8 weeks

• Safety-Adverse events

  8 weeks

Study Arms (1)

Medication arm

EXPERIMENTAL

Drug: Foquest

Interventions

Foquest DRUG

The drug being evaluated in this study is controlled release methylphenidate HCl control (Foquest®). Foquest® is a novel formulation of MPH developed by Purdue Pharma (Canada) and is approved in Canada for the treatment of ADHD in patients six years of age and older. Foquest® is the first methylphenidate product approved in Canada with an onset of action within one hour and a duration of action up to and including 16 hours (Wigal et al.2016). Foquest® is an ADHD treatment option for patients who require a rapid onset of action and extended duration of action

Medication arm

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JPM van Stralen Medicine Professional: lead
• Purdue Pharma, Canada: collaborator

Study Sites (1)

Center for Pediatric Excellence

Ottawa, Ontario, K2G1W2, Canada

Location

Related Publications (6)

• El Shakankiry HM. Sleep physiology and sleep disorders in childhood. Nat Sci Sleep. 2011 Sep 6;3:101-14. doi: 10.2147/NSS.S22839. Print 2011.

  PMID: 23616721 BACKGROUND

• Kidwell KM, Van Dyk TR, Lundahl A, Nelson TD. Stimulant Medications and Sleep for Youth With ADHD: A Meta-analysis. Pediatrics. 2015 Dec;136(6):1144-53. doi: 10.1542/peds.2015-1708.

  PMID: 26598454 BACKGROUND

• Faraone SV, Sergeant J, Gillberg C, Biederman J. The worldwide prevalence of ADHD: is it an American condition? World Psychiatry. 2003 Jun;2(2):104-13.

  PMID: 16946911 BACKGROUND

• Chatoor I, Wells KC, Conners CK, Seidel WT, Shaw D. The effects of nocturnally administered stimulant medication on EEG sleep and behavior in hyperactive children. J Am Acad Child Psychiatry. 1983 Jul;22(4):337-42. doi: 10.1016/s0002-7138(09)60668-3. No abstract available.

  PMID: 6875127 BACKGROUND

• Stein MA, Weiss M, Hlavaty L. ADHD treatments, sleep, and sleep problems: complex associations. Neurotherapeutics. 2012 Jul;9(3):509-17. doi: 10.1007/s13311-012-0130-0.

  PMID: 22718078 BACKGROUND

• Wigal SB, Wigal T, Childress A, Donnelly GAE, Reiz JL. The Time Course of Effect of Multilayer-Release Methylphenidate Hydrochloride Capsules: A Randomized, Double-Blind Study of Adults With ADHD in a Simulated Adult Workplace Environment. J Atten Disord. 2020 Feb;24(3):373-383. doi: 10.1177/1087054716672335. Epub 2016 Oct 17.

  PMID: 27756854 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Judy van Stralen, MD

  Center for Pediatric Excellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 5, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)