Clinical trial NCT06000501: Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
Official title: An Open-Label Treatment, Investigator-Initiated Study, on the Duration and Efficacy of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) on Adult ADHD Symptoms and Executive Function in Early Evening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adult Attention Deficit Hyperactivity Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Corium, Inc.
First posted: 2023-08-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-site study. One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD Investigator Symptom Rating Scale. The investigators will also examine Executive Function later in the day (early evening, about 12 hours after first morning dosing).


Eligibility criteria: Inclusion Criteria:

* Adults ages 18-60 years, inclusive at the time of consent
* Able to provide signed informed consent
* Any gender
* Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the ACDS Version 1.2.5, Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS 18 item total score of AISRS expanded of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total AISRS 18 item of AISRS EXPANDED score of ≥ 22 at screening
* Dysthymia and anxiety disorders in remission but stable on psychiatric medication for three weeks or more at the discretion of principal investigator will be allowed- medication for these disorders to remain constant for the duration of the protocol.
* Subjects who are stimulant naïve.

Exclusion Criteria:

* Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components.
* Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.
* Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except mood disorders accepted under the inclusion criteria at the discretion of the principal investigator.
* Active suicidality within past year, or history of suicide attempt in past 2 years
* Any history of severe past drug dependence determined by the MINI (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
* Concurrent substance abuse and/or history of substance use within 6 months
* Use of any prescribed benzodiazepine
* Any unstable medical or neurological condition; clinically significant medical abnormalities such as cardiovascular abnormalities, and any chronic condition of the central nervous system.
* Any psychotropic medication usage
* Known nonresponse to MPH treatment
* History of allergic reaction or sensitivity to MPH
* Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnant or men planning to make a woman pregnant during the study or for one-month post study
* PI/clinician discretion

Primary outcomes:
measure: Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 2
timeFrame: Baseline, Week 2
measure: Change in Expanded AISRS Score from Baseline to Week 5
timeFrame: Baseline, Week 5
Secondary outcomes:
measure: Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
timeFrame: Baseline, Week 2
measure: Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
timeFrame: Baseline, Week 5
measure: Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
timeFrame: Baseline, Week 2
measure: Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
timeFrame: Baseline, Week 5
measure: 1-Hour Post-Dose TASS Score at Visit 3
timeFrame: Week 2 (1-hour Post-Dose)
measure: 1-Hour Post-Dose TASS Score at Visit 4
timeFrame: Week 3 (1-hour Post-Dose)
measure: 1-Hour Post-Dose TASS Score at Visit 5
timeFrame: Week 4 (1-hour Post-Dose)
measure: 1-Hour Post-Dose TASS Score at Visit 6
timeFrame: Week 5 (1-hour Post-Dose)
measure: 4-Hour Post-Dose TASS Score at Visit 3
timeFrame: Week 2 (4-hours Post-Dose)
measure: 4-Hour Post-Dose TASS Score at Visit 4
timeFrame: Week 3 (4-hours Post-Dose)
measure: 4-Hour Post-Dose TASS Score at Visit 5
timeFrame: Week 4 (4-hours Post-Dose)
measure: 4-Hour Post-Dose TASS Score at Visit 6
timeFrame: Week 5 (4-hours Post-Dose)
measure: 12-Hour Post-Dose TASS Score at Visit 3
timeFrame: Week 2 (12-hours Post-Dose)
measure: 12-Hour Post-Dose TASS Score at Visit 4
timeFrame: Week 3 (12-hours Post-Dose)
measure: 12-Hour Post-Dose TASS Score at Visit 5
timeFrame: Week 4 (12-hours Post-Dose)
measure: 12-Hour Post-Dose TASS Score at Visit 6
timeFrame: Week 5 (12-hours Post-Dose)
measure: 1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
timeFrame: Week 2 (1-hour Post-Dose)
measure: 1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
timeFrame: Week 3 (1-hour Post-Dose)
measure: 1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
timeFrame: Week 4 (1-hour Post-Dose)
measure: 4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
timeFrame: Week 2 (4-hour Post-Dose)
measure: 4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
timeFrame: Week 3 (4-hour Post-Dose)
measure: 4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
timeFrame: Week 4 (4-hour Post-Dose)
measure: 4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
timeFrame: Week 5 (4-hour Post-Dose)
measure: 12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
timeFrame: Week 2 (12-hour Post-Dose)
measure: 12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
timeFrame: Week 3 (12-hour Post-Dose)
measure: 12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
timeFrame: Week 4 (12-hour Post-Dose)
measure: 12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
timeFrame: Week 5 (12-hour Post-Dose)
measure: Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
timeFrame: Baseline, Week 2
measure: Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
timeFrame: Baseline, Week 5
measure: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
timeFrame: Baseline, Week 2
measure: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
timeFrame: Baseline, Week 5
measure: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
timeFrame: Baseline, Week 2
measure: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
timeFrame: Baseline, Week 5
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lenard Adler
role: PRINCIPAL_INVESTIGATOR
References: