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Foquest for ADHD in Children

Phase 4
Waitlist Available
Led By Judy van Stralen, MD
Research Sponsored by JPM van Stralen Medicine Professional
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing the effect of Foquest on sleep in children. It will compare them to a baseline of no medication and look at actigraphy and sleep diaries.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of Foquest® are not listed here, stimulant medications like it can sometimes affect sleep by making it harder to fall asleep or reducing total sleep time. Other common side effects may include mood swings, behavioral changes, decreased appetite, headaches, stomachaches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in sleep onset latency
Secondary study objectives
ADHD Symptoms
Executive Function
Improvements of Subjects
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Medication armExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

JPM van Stralen Medicine ProfessionalLead Sponsor
2 Previous Clinical Trials
98 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
98 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Purdue Pharma, CanadaIndustry Sponsor
8 Previous Clinical Trials
1,443 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,136 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Judy van Stralen, MDPrincipal InvestigatorCenter for Pediatric Excellence
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
48 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~8 spots leftby Nov 2025
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