← Back to Search

Other

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in sleep onset latency

Secondary outcome measures

ADHD Symptoms

Executive Function

Improvements of Subjects

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Medication armExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have enrolled in this experiment?

"Affirmative. The pertinent data on clinicaltrials.gov affirms that this scientific experiment, which was published originally on December 1st 2020, is actively recruiting participants. Approximately 29 individuals must be recruited from a single medical facility."

Answered by AI

Are there any unoccupied spots in this research program?

"According to the clinicaltrials.gov listing, this medical trial is currently enlisting volunteers for participation. It was first uploaded on December 1st 2020 and its information has been refreshed as recently as March 28th 2022."

Answered by AI

What adverse effects could arise from using Foquest medicinally?

"Data from Phase 4 trials indicates that Foquest is a secure treatment option, warranting it an overall safety score of 3."

Answered by AI

What past experiments have been conducted with Foquest as a therapeutic agent?

"Currently, 29 clinical trials examining Foquest are underway with 2 of them in Phase 3. Lexington Kentucky is hosting several of the studies but 42 locations across the country offer access to this research."

Answered by AI

Is this clinical trial open to applicants who are younger than 70 years of age?

"This trial is targeting participants between the ages of 6 and 12, with 117 opportunities for individuals under 18 years old and 50 options available to those above 65."

Answered by AI

Am I able to join this medical research endeavor?

"Participants of this medical trial should be diagnosed with hyperkinesis and must fall within the age bracket of 6 to 12 years old. 29 individuals are being sought after in total."

Answered by AI

Recent research and studies

Journal of the American Academy of Child PsychiatryJournal

The Effects of Nocturnally Administered Stimulant Medication on EEG Sleep and Behavior in Hyperactive Children

CHATOOR, IRENE, KAREN C. WELLS, C. KEITH CONNERS, WILLIAM T. SEIDEL, and DANIEL SHAW. 1983. “The Effects of Nocturnally Administered Stimulant Medication on EEG Sleep and Behavior in Hyperactive Children”. Journal of the American Academy of Child Psychiatry. Elsevier BV. doi:10.1016/s0002-7138(09)60668-3.

Journal of Child Psychology and PsychiatryJournal

Predictive Validity of ICD-10 Hyperkinetic Disorder Relative to DSM-IV Attention-deficit/hyperactivity Disorder Among Younger Children

Lahey, Benjamin B., William E. Pelham, Andrea Chronis, Greta Massetti, Heidi Kipp, Ashley Ehrhardt, and Steve S. Lee. 2006. “Predictive Validity of ICD-10 Hyperkinetic Disorder Relative to DSM-IV Attention-deficit/hyperactivity Disorder Among Younger Children”. Journal of Child Psychology and Psychiatry. Wiley. doi:10.1111/j.1469-7610.2005.01590.x.

PediatricsJournal

Stimulant Medications and Sleep for Youth with ADHD: A Meta-analysis

Kidwell, Katherine M., Tori R. Van Dyk, Alyssa Lundahl, and Timothy D. Nelson. 2015. “Stimulant Medications and Sleep for Youth with ADHD: A Meta-analysis”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2015-1708.

NeurotherapeuticsJournal