Trial Outcomes & Findings for An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD (NCT NCT05685732)

Last Updated: 2025-05-13

Results Overview

The ADHD-RS is an 18-item scale based on Diagnostic and Statistical Manual of Mental Disorders criteria of ADHD that rates symptoms on a 4-point scale. Each item is scored using a combination of severity and frequency ratings from a range of 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of very often), so that the total ADHD-RS scores range from 0 to 54. Scores will be obtained during a clinician-directed interview with the parent/guardian/caregiver at each visit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

246 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: SDX/d-MPH in 4-5 Year Old 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 1: Placebo in 4-5 Year Old matching placebo placebo: matching placebo	Cohort 2: SDX/d-MPH in 6-12 Year Old 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 2: Placebo in 6-12 Year Old matching placebo placebo: matching placebo
Overall Study STARTED	68	69	54	55
Overall Study COMPLETED	57	65	45	50
Overall Study NOT COMPLETED	11	4	9	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: SDX/d-MPH in 4-5 Year Old 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 1: Placebo in 4-5 Year Old matching placebo placebo: matching placebo	Cohort 2: SDX/d-MPH in 6-12 Year Old 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 2: Placebo in 6-12 Year Old matching placebo placebo: matching placebo
Overall Study Withdrawal by Subject	2	0	2	3
Overall Study Protocol Violation	1	2	4	1
Overall Study Lost to Follow-up	5	1	3	1
Overall Study Adverse Event	2	1	0	0
Overall Study Physician Decision	1	0	0	0

Baseline Characteristics

An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: SDX/d-MPH in 4-5 Year Old n=64 Participants 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 1: Placebo in 4-5 Year Old n=69 Participants matching placebo placebo: matching placebo	Cohort 2: SDX/d-MPH in 6-12 Year Old n=52 Participants 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 2: Placebo in 6-12 Year Old n=55 Participants matching placebo placebo: matching placebo	Total n=240 Participants Total of all reporting groups
Age, Continuous	4.6 Years STANDARD_DEVIATION .50 • n=5 Participants	4.5 Years STANDARD_DEVIATION .50 • n=7 Participants	8.3 Years STANDARD_DEVIATION 1.87 • n=5 Participants	8.6 Years STANDARD_DEVIATION 2.26 • n=4 Participants	6.3 Years STANDARD_DEVIATION 2.43 • n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	14 Participants n=5 Participants	15 Participants n=4 Participants	67 Participants n=21 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	49 Participants n=7 Participants	38 Participants n=5 Participants	40 Participants n=4 Participants	173 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants	27 Participants n=4 Participants	83 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White	39 Participants n=5 Participants	46 Participants n=7 Participants	24 Participants n=5 Participants	25 Participants n=4 Participants	134 Participants n=21 Participants
Race/Ethnicity, Customized Other/Multiple	7 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Body Mass Index kg/m2	16.12 kg/m2 STANDARD_DEVIATION 1.480 • n=5 Participants	16.06 kg/m2 STANDARD_DEVIATION 1.534 • n=7 Participants	17.06 kg/m2 STANDARD_DEVIATION 2.491 • n=5 Participants	17.55 kg/m2 STANDARD_DEVIATION 2.946 • n=4 Participants	16.64 kg/m2 STANDARD_DEVIATION 2.220 • n=21 Participants
Height	111.97 cm STANDARD_DEVIATION 5.827 • n=5 Participants	109.83 cm STANDARD_DEVIATION 5.356 • n=7 Participants	133.52 cm STANDARD_DEVIATION 13.126 • n=5 Participants	135.66 cm STANDARD_DEVIATION 14.551 • n=4 Participants	121.45 cm STANDARD_DEVIATION 15.586 • n=21 Participants
Weight	20.29 kg STANDARD_DEVIATION 3.049 • n=5 Participants	19.38 kg STANDARD_DEVIATION 2.266 • n=7 Participants	31.05 kg STANDARD_DEVIATION 9.229 • n=5 Participants	33.19 kg STANDARD_DEVIATION 11.049 • n=4 Participants	25.31 kg STANDARD_DEVIATION 9.383 • n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Cohort 1: SDX/d-MPH in 4-5 Year Old n=64 Participants 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 1: Placebo in 4-5 Year Old n=69 Participants matching placebo placebo: matching placebo	Cohort 2: SDX/d-MPH in 6-12 Year Old n=52 Participants 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 2: Placebo in 6-12 Year Old n=55 Participants matching placebo placebo: matching placebo
A Comparison of the Change in Mean ADHD Rating Scale (ADHD-RS) Results From Baseline to End of Treatment Between Active and Placebo Treatments.	-18.6 score on a scale Interval -21.9 to -15.4	-4.4 score on a scale Interval -7.4 to -1.3	-17.6 score on a scale Interval -21.6 to -13.6	-10.3 score on a scale Interval -14.2 to -6.4

SECONDARY outcome

Timeframe: 4 weeks

The CGI-S is a clinician-rated scale that evaluates the severity of ADHD symptoms in the study on a scale from 1 (not at all ill) to 7 (among the most severely ill).

Outcome measures

Outcome measures
Measure	Cohort 1: SDX/d-MPH in 4-5 Year Old n=57 Participants 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 1: Placebo in 4-5 Year Old n=66 Participants matching placebo placebo: matching placebo	Cohort 2: SDX/d-MPH in 6-12 Year Old n=52 Participants 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 2: Placebo in 6-12 Year Old n=55 Participants matching placebo placebo: matching placebo
A Comparison of the Change in Mean Clinical Global Impressions-Severity (CGI-S) Results From Baseline to End of Treatment Between Active and Placebo Treatments.	-1.6 score on a scale Interval -1.9 to -1.3	-0.5 score on a scale Interval -0.8 to -0.2	-1.0 score on a scale Interval -1.4 to -0.7	-0.6 score on a scale Interval -1.0 to -0.3

SECONDARY outcome

Timeframe: 3 weeks

The CGI-I is a clinician-rated scale that evaluates the improvement of ADHD symptoms in the study on a scale from 1 (very much improved) to 7 (very much worse).

Outcome measures

Outcome measures
Measure	Cohort 1: SDX/d-MPH in 4-5 Year Old n=57 Participants 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 1: Placebo in 4-5 Year Old n=66 Participants matching placebo placebo: matching placebo	Cohort 2: SDX/d-MPH in 6-12 Year Old n=46 Participants 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 2: Placebo in 6-12 Year Old n=49 Participants matching placebo placebo: matching placebo
A Comparison of the Change in Mean Clinical Global Impressions-Improvement (CGI-I) Results From Visit 3 to End of Treatment Between Active and Placebo Treatments.	2.4 score on a scale Interval 2.2 to 2.7	3.7 score on a scale Interval 3.4 to 3.9	2.4 score on a scale Interval 2.0 to 2.7	3.2 score on a scale Interval 2.9 to 3.6

Adverse Events

Cohort 1: SDX/d-MPH in 4-5 Year Olds

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Cohort 1: Placebo in 4-5 Year Olds

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort 2: SDX/d-MPH in 6-12 Year Olds

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Cohort 2: Placebo in 6-12 Year Olds

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1: SDX/d-MPH in 4-5 Year Olds n=65 participants at risk 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 1: Placebo in 4-5 Year Olds n=69 participants at risk matching placebo dose levels placebo: matching placebo	Cohort 2: SDX/d-MPH in 6-12 Year Olds n=54 participants at risk 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH): Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Cohort 2: Placebo in 6-12 Year Olds n=55 participants at risk matching placebo dose levels placebo: matching placebo
Psychiatric disorders Insomnia	4.6% 3/65 • Number of events 3 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	0.00% 0/69 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	11.1% 6/54 • Number of events 6 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	0.00% 0/55 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days
Psychiatric disorders Irritability	7.7% 5/65 • Number of events 5 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	0.00% 0/69 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	7.4% 4/54 • Number of events 4 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	0.00% 0/55 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days
Gastrointestinal disorders Gastrointestinal disorders	13.8% 9/65 • Number of events 9 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	2.9% 2/69 • Number of events 2 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	20.4% 11/54 • Number of events 11 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	5.5% 3/55 • Number of events 3 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days
Metabolism and nutrition disorders Decreased appetite	10.8% 7/65 • Number of events 7 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	4.3% 3/69 • Number of events 3 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	20.4% 11/54 • Number of events 11 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	1.8% 1/55 • Number of events 1 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days
Infections and infestations Infections and Infestations	7.7% 5/65 • Number of events 5 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	13.0% 9/69 • Number of events 9 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	1.9% 1/54 • Number of events 1 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	7.3% 4/55 • Number of events 4 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days
Investigations Investigations	1.5% 1/65 • Number of events 1 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	1.4% 1/69 • Number of events 1 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	9.3% 5/54 • Number of events 5 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	3.6% 2/55 • Number of events 2 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days
Nervous system disorders Nervous system disorders	1.5% 1/65 • Number of events 1 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	0.00% 0/69 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	9.3% 5/54 • Number of events 5 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days	1.8% 1/55 • Number of events 1 • AE data were collected beginning from the time of first study drug administration through five days after the last dose of study drug. This total time period is 33 days, +/- 2 days

Additional Information

Ronald Tashjian

Corium, LLC

Phone: 6172337474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution/PI shall have the right to publish results pertaining to Institution's or PI's Study activities (individually, a "Publication") for their own publication objectives, provided that such Publication does not disclose Confidential Information (CI) as described in the Agreement. At least ninety (90) days prior to submission for publication, presentation or use, Institution and PI shall submit in writing to Sponsor for review and comment of any proposed oral or written Publication.
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