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Cohort 1: SDX/d-MPH in 4-5 year old for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
IMMUNOe International Research center, Centennial, COAttention Deficit Hyperactivity Disorder (ADHD)Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) - Drug
Eligibility
4 - 12
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the efficacy and safety of a medicine (Azstarys®) for treating ADHD in children 4-12 years old. 130 & 100 children from 20 sites will be enrolled and randomized.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

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2
Behavioral Parent Training

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 4 weeks

3 weeks
A comparison of the change in mean Clinical Global Impressions-Improvement (CGI-I) results from Visit 3 to end of treatment between active and placebo treatments.
4 weeks
A comparison of the change in mean ADHD Rating Scale (ADHD-RS) results from baseline to end of treatment between active and placebo treatments.
A comparison of the change in mean Clinical Global Impressions-Severity (CGI-S) results from baseline to end of treatment between active and placebo treatments.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Centanafadine
1
YJ001 for Spray Use
3
Behavioral Parent Training

Side Effects for

Group 3: Guan-Guan+DMPH
36%Decreased Appetite
34%Insomnia
33%Headache
26%Irritability
23%Lethargy
23%Abdominal Pain
23%Sedation
21%Somnolence
17%Fatigue
14%Abdominal Pain Upper
11%Affect Lability
10%Dizziness
This histogram enumerates side effects from a completed 2011 Phase 4 trial (NCT00429273) in the Group 3: Guan-Guan+DMPH ARM group. Side effects include: Decreased Appetite with 36%, Insomnia with 34%, Headache with 33%, Irritability with 26%, Lethargy with 23%.

Trial Design

4 Treatment Groups

Cohort 1: SDX/d-MPH in 4-5 year old
1 of 4
Cohort 2: SDX/d-MPH in 6-12 year old
1 of 4
Cohort 1: Placebo in 4-5 year old
1 of 4
Cohort 2: Placebo in 6-12 year old
1 of 4

Experimental Treatment

Non-Treatment Group

230 Total Participants · 4 Treatment Groups

Primary Treatment: Cohort 1: SDX/d-MPH in 4-5 year old · Has Placebo Group · Phase 4

Cohort 1: SDX/d-MPH in 4-5 year old
Drug
Experimental Group · 1 Intervention: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) · Intervention Types: Drug
Cohort 2: SDX/d-MPH in 6-12 year old
Drug
Experimental Group · 1 Intervention: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) · Intervention Types: Drug
Cohort 1: Placebo in 4-5 year old
Other
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: Other
Cohort 2: Placebo in 6-12 year old
Other
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks

Who is running the clinical trial?

Corium, Inc.Lead Sponsor
7 Previous Clinical Trials
699 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
100 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Premier Research Group plcIndustry Sponsor
58 Previous Clinical Trials
34,005 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
542 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Prometrika, LLCUNKNOWN
3 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
100 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
AlmacUNKNOWN
3 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
100 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Ann Childress, MDPrincipal InvestigatorCenter for Psychiatry And Behavioral Medicine Inc.
10 Previous Clinical Trials
1,706 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,706 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Age 4 - 12 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be generally healthy with no major health problems, as determined by the study doctor through various tests and exams. If any of your test results are slightly abnormal, the doctor will decide if it is still safe for you to participate.
A parent or legal guardian must give written permission for the child to participate in the study.
You have been experiencing symptoms of ADHD for at least 6 months before the screening visit.
For Cohort 1, you must be between 4 and 5 years and 10 months old during the screening process. For Cohort 2, you must be between 6 and 12 years and 10 months old during the screening process.
You must weigh between a healthy range based on your age and gender according to the CDC weight charts. You can check your weight range using the calculator provided at https://www.infantchart.com/child/.
If you are a female and able to have children, you need to agree to not get pregnant or use a reliable form of birth control during the study and for 14 days after the last dose of study drug. If you are 12 years old or older, you are considered capable of having children even if you have not started menstruating yet. If you have started menstruating, you are also considered capable of having children.
If you are in Cohort 2, you must agree in writing or verbally to participate in the study. If you give verbal agreement, someone else must witness your agreement and sign a document. A parent or guardian cannot be the witness for a child's verbal agreement.
You have been diagnosed with ADHD by a clinician and this diagnosis has been confirmed by a standardized test called MINI Kid.
You should stop taking any ADHD medication, including herbal ones, at least 5 days before the start of the treatment period. You should also stop taking non-stimulant ADHD medications at least 14 days before the start of the treatment period. You cannot take any of these medications until the end of Visit 6.
You must have a moderate level of illness according to the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale. If you are taking medication for ADHD, this criteria applies after you have stopped taking the medication for a certain period of time.
References

Frequently Asked Questions

Is this research allowing for the inclusion of participants over 50 years old?

"In order to be eligible, individuals must fall within the age bracket of 4 and 12. Additionally, this trial has a total of 111 participants under 18 years old and 35 who are over 65." - Anonymous Online Contributor

Unverified Answer

Is my profile compatible with the requirements for this research endeavor?

"This clinical trial requires that interested candidates have a diagnosis of attention deficit hyperactivity disorder (ADHD), are between the ages of 4 and 12, and can commit to participation. Approximately 230 individuals need to be enrolled for this research project." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available for individuals to join the experiment?

"Clinicaltrials.gov reveals that this experiment is currently in search of volunteers, with an original posting date of 2/20/2023 and a recent update on the day after." - Anonymous Online Contributor

Unverified Answer

In what locations are this investigation's facilities located?

"This investigation is currently recruiting patients from 22 separate sites, which include Little Rock, Centennial and Clermont. To minimize the associated burden of travel, interested applicants should select a location nearby them to ensure their convenience." - Anonymous Online Contributor

Unverified Answer

How many individuals can enroll in this experiment?

"Corium, Inc., the sponsor of this trial, requires 230 eligible participants to successfully carry out their study. Recruitment will take place at Preferred Research Partners in Little Rock and IMMUNOe International Research centre located in Centennial, Colorado." - Anonymous Online Contributor

Unverified Answer

Has Cohort 1: SDX/d-MPH received government clearance for use in children aged 4-5?

"Given the Phase 4 nature of this trial, which means it has already been approved, our team assigned a 3 to Cohort 1: SDX/d-MPH in 4-5 year olds for safety." - 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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