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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

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
968 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
369 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,812 Total Patients Enrolled
12 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
658 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Lenard AdlerPrincipal InvestigatorNYU Langone Health
~6 spots leftby Dec 2024
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