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Stimulant

Azstarys for ADHD

Phase 4
Recruiting
Led By Lenard Adler
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5 (12-hours post-dose)
Awards & highlights

Study Summary

This trial will look at how Azstarys affects adults with ADHD in terms of symptoms, Executive Function, and safety.

Who is the study for?
Adults aged 18-60 with ADHD, not currently on medication or stimulant-naïve, can join this study. They must have certain scores on the AISRS scale to qualify. People with stable dysthymia and anxiety may participate if their meds are unchanged for three weeks. Pregnant women, those planning pregnancy, or men planning to father a child soon cannot join.Check my eligibility
What is being tested?
The trial is testing Azstarys's ability to manage ADHD symptoms and improve executive function in adults during early evening hours. It's an open-label study where all participants know they're receiving Azstarys and its effects are measured using specific rating scales.See study design
What are the potential side effects?
While the side effects of Azstarys aren't detailed here, similar medications often cause insomnia, decreased appetite, weight loss, increased heart rate, mood swings, and potential for abuse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5 (12-hours post-dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 5 (12-hours post-dose) 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 Expanded AISRS Score from Baseline to Week 5
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 2
Secondary outcome measures
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
+25 more

Side effects data

From 2011 Phase 4 trial • 212 Patients • NCT00429273
36%
Decreased Appetite
34%
Insomnia
33%
Headache
26%
Irritability
23%
Abdominal Pain
23%
Sedation
23%
Lethargy
21%
Somnolence
17%
Fatigue
14%
Abdominal Pain Upper
11%
Affect Lability
10%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Guan-Guan+Placebo
Group 2: Placebo-Placebo+DMPH
Group 3: Guan-Guan+DMPH

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adult ADHD PatientsExperimental Treatment1 Intervention
Enrolled participants will begin with a two-week observation stabilization before starting treatment with Azstarys. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will be dispensed a three-week supply of Azstarys on a weekly basis.

Find a Location

Who is running the clinical trial?

Corium, Inc.Industry Sponsor
8 Previous Clinical Trials
945 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
346 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,568 Total Patients Enrolled
12 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
678 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Lenard AdlerPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

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

Has the FDA verified the use of medications for treating Adult ADHD?

"Adult ADHD patients have a safety score of 3, since this is a Phase 4 clinical trial and the treatment has already received approval."

Answered by AI

Is recruitment for this research endeavor still taking place?

"All evidence points to this clinical trial still needing enrollees. The experiment was initially posted on September 14th 2023 and has since been revised most recently on the 15th of same month."

Answered by AI

Is this clinical trial open to participants aged thirty and above?

"This research effort is open to adults aged 18-60. Kindly note that there are 90 studies available for minors and 30 clinical trials specifically designed for seniors over 65 years old."

Answered by AI

How many volunteers are involved in this experiment?

"Affirmative. Clinicaltrials.gov shows that this clinical trial, initiated on September 14th 2023, is seeking out suitable applicants. 30 individuals are being recruited from a single medical centre."

Answered by AI

Who is the ideal candidate to partake in this research endeavor?

"The prerequisites for this clinical trial involve having a diagnosis of ADHD, and being between the ages 18 to 60. Currently, 30 individuals are eligible to partake in this research."

Answered by AI

What goals is the research hoping to realize?

"As measured at both Baseline and Week 2, the primary aim of this trial is to determine Change in Expanded AISRS Score. Secondary outcomes that will be tracked include Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score, 1-Hour Post-Dose TASS Score at Visit 3, and 1-Hour Post-Dose TASS Score at Visit 4; all three parameters are rated on a four point Likert scale ranging from 0 (none) to 3 (severe)."

Answered by AI

Who else is applying?

What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
2023. "Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06000501.
All > Adhd
~16 spots leftby Dec 2024
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