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Stimulant
Azstarys for ADHD
Phase 4
Waitlist Available
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
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 5 (12-hours post-dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5 (12-hours post-dose)
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Serdexmethylphenidate/dexmethylphenidate
2023
Completed Phase 4
~30
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
1,414 Previous Clinical Trials
855,753 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