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FRx-004 for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Revibe Technologies, Wake Forest, NCAttention Deficit Hyperactivity Disorder (ADHD)FRx-004 - Device
Eligibility
8 - 12
All Sexes
What conditions do you have?
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Study Summary

This trial looks at how digital devices can help kids with ADHD manage symptoms and improve their functioning.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Change from Baseline to Post-intervention (4 weeks)

Week 4
ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale
ADHD Rating Scale-5, Home Version: Hyperactivity-Impulsivity Subscale
ADHD Rating Scale-5, Home Version: Inattention Subscale
ADHD Rating Scale-5, Home Version: Total score
ADHD Rating Scale-5, School Version: Hyperactivity-Impulsivity Subscale
ADHD Rating Scale-5, School Version: Total score
Academic Performance Rating Scale
Comprehensive Executive Function Inventory: Parent
Comprehensive Executive Function Inventory: Teacher
Conners 4, Short Form: Parent
Conners 4, Short Form: Teacher
Impairment Rating Scale - Parent
Impairment Rating Scale - Teacher
Weiss Functional Impairment Rating Scale - Parent Form

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Methylphenidate
1
Centanafadine
1
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Trial Design

3 Treatment Groups

FRx-004
1 of 3
FRx-001
1 of 3
FRx-003
1 of 3

Active Control

150 Total Participants · 3 Treatment Groups

Primary Treatment: FRx-004 · No Placebo Group · N/A

FRx-004
Device
ActiveComparator Group · 1 Intervention: FRx-004 · Intervention Types: Device
FRx-001
Device
ActiveComparator Group · 1 Intervention: FRx-001 · Intervention Types: Device
FRx-003
Device
ActiveComparator Group · 1 Intervention: FRx-003 · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to post-intervention (4 weeks)

Who is running the clinical trial?

Revibe TechnologiesLead Sponsor

Eligibility Criteria

Age 8 - 12 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study does not include children or teenagers.
You must be attending school in-person during the trial period, not online or in a hybrid setting.
A parent has rated your ADHD symptoms with a score of 28 or higher on a scale called ADHD-RS-5.
You have been diagnosed with ADHD by a parent or guardian.
You must be between 8 and 12 years old.
You must be a resident of the United States.
You need to have a good understanding of the English language.
You should be able to read and understand English at an elementary school level either by yourself or with the help of an adult.
You need to wear a device on your wrist every weekday for four weeks while you're in school.
Your parent filled out a questionnaire about your behavior and rated your ADHD symptoms. If your total score on this questionnaire is less than 28, you can still participate in the study but your data won't be included in certain analyses.
References

Frequently Asked Questions

Is this study recruiting individuals aged 35 and younger?

"This medical trial is looking for children that are between 8 and 12 years old." - Anonymous Online Contributor

Unverified Answer

Are there still places available to join this research endeavor?

"According to the clinicaltrials.gov listing, this medical study is actively collecting participants at present. The research was first submitted on February 15th 2023 and its details were revised most recently that same day." - Anonymous Online Contributor

Unverified Answer

What is the total enrollment number for this investigation?

"Correct. Data published on clinicaltrials.gov confirms that this medical study, which was posted initially on February 15th 2023 is actively enrolling participants. 150 patients are needed from 1 research centre." - Anonymous Online Contributor

Unverified Answer

Is participation in this clinical experiment open to the public?

"This clinical trial is targeting 150 minors aged 8-12 who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). All participants must be located in the United States, able to understand and read English at grade level either independently or with adult assistance. Additionally, all youth participating are required to wear a device on their wrist for four weeks during school hours from Monday through Friday. The eligibility criteria includes an ADHD Rating Scale version 5 total score of 28 or greater as determined by parent ratings on the baseline questionnaire; however, those scoring below this threshold may participate but will not included in per protocol analyses." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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