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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06000501




Registration number
NCT06000501
Ethics application status
Date submitted
14/08/2023
Date registered
21/08/2023
Date last updated
1/10/2024

Titles & IDs
Public title
Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
Scientific 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
Secondary ID [1] 0 0
22-01003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Attention Deficit Hyperactivity Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Serdexmethylphenidate/dexmethylphenidate

Experimental: Adult ADHD Patients - 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: Drugs: Serdexmethylphenidate/dexmethylphenidate
Azstarys capsules for once-daily oral use for three weeks. Flexible dose starting at 39.2 mg serd-mph/7.8 mg d-mph and moving up to 52.3 mg serd-mph/10.4 mg d-mph.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 2
Timepoint [1] 0 0
Baseline, Week 2
Primary outcome [2] 0 0
Change in Expanded AISRS Score from Baseline to Week 5
Timepoint [2] 0 0
Baseline, Week 5
Secondary outcome [1] 0 0
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Timepoint [1] 0 0
Baseline, Week 2
Secondary outcome [2] 0 0
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Timepoint [2] 0 0
Baseline, Week 5
Secondary outcome [3] 0 0
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Timepoint [3] 0 0
Baseline, Week 2
Secondary outcome [4] 0 0
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Timepoint [4] 0 0
Baseline, Week 5
Secondary outcome [5] 0 0
1-Hour Post-Dose TASS Score at Visit 3
Timepoint [5] 0 0
Week 2 (1-hour Post-Dose)
Secondary outcome [6] 0 0
1-Hour Post-Dose TASS Score at Visit 4
Timepoint [6] 0 0
Week 3 (1-hour Post-Dose)
Secondary outcome [7] 0 0
1-Hour Post-Dose TASS Score at Visit 5
Timepoint [7] 0 0
Week 4 (1-hour Post-Dose)
Secondary outcome [8] 0 0
1-Hour Post-Dose TASS Score at Visit 6
Timepoint [8] 0 0
Week 5 (1-hour Post-Dose)
Secondary outcome [9] 0 0
4-Hour Post-Dose TASS Score at Visit 3
Timepoint [9] 0 0
Week 2 (4-hours Post-Dose)
Secondary outcome [10] 0 0
4-Hour Post-Dose TASS Score at Visit 4
Timepoint [10] 0 0
Week 3 (4-hours Post-Dose)
Secondary outcome [11] 0 0
4-Hour Post-Dose TASS Score at Visit 5
Timepoint [11] 0 0
Week 4 (4-hours Post-Dose)
Secondary outcome [12] 0 0
4-Hour Post-Dose TASS Score at Visit 6
Timepoint [12] 0 0
Week 5 (4-hours Post-Dose)
Secondary outcome [13] 0 0
12-Hour Post-Dose TASS Score at Visit 3
Timepoint [13] 0 0
Week 2 (12-hours Post-Dose)
Secondary outcome [14] 0 0
12-Hour Post-Dose TASS Score at Visit 4
Timepoint [14] 0 0
Week 3 (12-hours Post-Dose)
Secondary outcome [15] 0 0
12-Hour Post-Dose TASS Score at Visit 5
Timepoint [15] 0 0
Week 4 (12-hours Post-Dose)
Secondary outcome [16] 0 0
12-Hour Post-Dose TASS Score at Visit 6
Timepoint [16] 0 0
Week 5 (12-hours Post-Dose)
Secondary outcome [17] 0 0
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Timepoint [17] 0 0
Week 2 (1-hour Post-Dose)
Secondary outcome [18] 0 0
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
Timepoint [18] 0 0
Week 3 (1-hour Post-Dose)
Secondary outcome [19] 0 0
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
Timepoint [19] 0 0
Week 4 (1-hour Post-Dose)
Secondary outcome [20] 0 0
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Timepoint [20] 0 0
Week 2 (1-hour Post-Dose)
Secondary outcome [21] 0 0
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
Timepoint [21] 0 0
Week 3 (1-hour Post-Dose)
Secondary outcome [22] 0 0
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
Timepoint [22] 0 0
Week 4 (1-hour Post-Dose)
Secondary outcome [23] 0 0
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
Timepoint [23] 0 0
Week 5 (1-hour Post-Dose)
Secondary outcome [24] 0 0
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Timepoint [24] 0 0
Week 2 (1-hour Post-Dose)
Secondary outcome [25] 0 0
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
Timepoint [25] 0 0
Week 3 (1-hour Post-Dose)
Secondary outcome [26] 0 0
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
Timepoint [26] 0 0
Week 4 (1-hour Post-Dose)
Secondary outcome [27] 0 0
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
Timepoint [27] 0 0
Week 5 (1-hour Post-Dose)
Secondary outcome [28] 0 0
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
Timepoint [28] 0 0
Baseline, Week 2
Secondary outcome [29] 0 0
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
Timepoint [29] 0 0
Baseline, Week 5
Secondary outcome [30] 0 0
Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
Timepoint [30] 0 0
Baseline, Week 2
Secondary outcome [31] 0 0
Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
Timepoint [31] 0 0
Baseline, Week 5
Secondary outcome [32] 0 0
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Timepoint [32] 0 0
Baseline, Week 2
Secondary outcome [33] 0 0
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Timepoint [33] 0 0
Baseline, Week 5

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/07/2024
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
NYU Langone Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Corium, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06000501
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Lenard Adler
Address 0 0
NYU Langone Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06000501