Foquest for ADHD in Children

Recruiting in Palo Alto (17 mi)

Overseen ByJudy van Stralen, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: JPM van Stralen Medicine Professional

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for children aged 6-12 with ADHD, who meet the DSM-V criteria for ADHD and have normal blood pressure. They must be able to follow the study protocol and wear an actigraphic wrist device. It's not for kids allergic or non-responsive to methylphenidate, with certain medical conditions like seizure disorders or severe renal insufficiency, taking MAO inhibitors, or with a primary diagnosis of bipolar disorder.

Inclusion Criteria

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 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

+2 more

Exclusion Criteria

You are allergic to methylphenidate, had serious bad reactions to it, or it didn't work for you after trying it at different doses for at least four weeks each within the past 10 years.

Females of child-bearing potential (FOCP) who are pregnant, planning on becoming pregnant or breast feeding

You have a history of seizures, except for a single fever-related seizure before you were 3 years old.

+6 more

Participant Groups

The trial tests how Foquest® affects sleep in children with ADHD using sleep tracking (actigraphy) and diaries. Researchers want to see if this medication changes how quickly kids fall asleep and improves their total sleep time compared to when they're not on any medication.

1Treatment groups

Experimental Treatment

Group I: Medication armExperimental Treatment1 Intervention