Trial Outcomes & Findings for Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (NCT NCT06000501)
NCT ID: NCT06000501
Last Updated: 2025-07-29
Results Overview
The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 102; higher scores indicate more severe symptoms of ADHD.
COMPLETED
PHASE4
29 participants
Week 2, Week 5
2025-07-29
Participant Flow
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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17
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Overall Study
NOT COMPLETED
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12
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Reasons for withdrawal
| Measure |
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.
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.
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|---|---|
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Overall Study
Screen failure
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3
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Overall Study
Severe past drug dependence determined by the MINI
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2
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Overall Study
Physician Decision
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4
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Overall Study
Positive Urine Drug Test (UDT)
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1
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Overall Study
Scheduling issues
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2
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Baseline Characteristics
Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
Baseline characteristics by cohort
| Measure |
Adult ADHD Patients
n=17 Participants
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.
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.
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Age, Continuous
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31.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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8 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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8 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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17 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 2, Week 5The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 102; higher scores indicate more severe symptoms of ADHD.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
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Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
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24.1 score on a scale
Standard Deviation 7.4
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SECONDARY outcome
Timeframe: Week 2, Week 5The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. The 9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
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Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
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14.3 score on a scale
Standard Deviation 4
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SECONDARY outcome
Timeframe: Week 2, Week 5The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. The 9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
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Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
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9.7 score on a scale
Standard Deviation 4.2
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SECONDARY outcome
Timeframe: Week 2, Week 5The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. The 9-item subscale of the AISRS assessing executive dysfunction symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
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|---|---|
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Change in Expanded AISRS - Overall Executive Dysfunction (EFD) Subscale Score
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14.5 score on a scale
Standard Deviation 5.1
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SECONDARY outcome
Timeframe: Week 2, Week 5The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. The 9-item subscale of the AISRS assessing emotional control symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
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Change in Expanded AISRS - Overall Emotional Control (EC) Subscale Score
|
5.3 score on a scale
Standard Deviation 4.8
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SECONDARY outcome
Timeframe: Week 2, Week 5The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The total score is calculated as the sum of all item responses and ranges from 0 to 124, with higher scores indicating greater frequency of ADHD symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist DSM-5 Expanded Score
|
25.6 score on a scale
Standard Deviation 13.7
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SECONDARY outcome
Timeframe: Week 2, Week 5The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The IA score ranges from 0-36. Higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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|---|---|
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Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Inattentive (IA) Subscale Score
|
14.4 score on a scale
Standard Deviation 7.6
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SECONDARY outcome
Timeframe: Week 2, Week 5The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The HI score ranges from 0-36. Higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Hyperactive (HI) Subscale Score
|
11.1 score on a scale
Standard Deviation 7.2
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SECONDARY outcome
Timeframe: Week 2, Week 5The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The EFD score ranges from 0-36. Higher scores indicating greater symptom severity.symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Executive Dysfunction (EFD) Subscale Score
|
12.6 score on a scale
Standard Deviation 6.2
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SECONDARY outcome
Timeframe: Week 2, Week 5The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The ED score ranges from 0-36. Higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score Overall Emotional Dyscontrol (ED) Subscale Score
|
5.9 score on a scale
Standard Deviation 5
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SECONDARY outcome
Timeframe: Week 2, Week 518-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
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Change in 1-Hour Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score
|
12.3 score on a scale
Standard Deviation 10
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SECONDARY outcome
Timeframe: Week 2, Week 518-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
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Change in 4-Hour Post-Dose TASS Score
|
12.6 score on a scale
Standard Deviation 10.5
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SECONDARY outcome
Timeframe: Week 2, Week 518-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
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|---|---|
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Change in 12-Hour Post-Dose TASS Score
|
9.3 score on a scale
Standard Deviation 10.5
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SECONDARY outcome
Timeframe: Week 3AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
|
2.86 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Week 3AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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|---|---|
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Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
|
2.64 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Week 3AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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|---|---|
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Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
|
2.07 score on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Week 3AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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|---|---|
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Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
|
1.64 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Week 3AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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|---|---|
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Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
|
1.21 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Week 4AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
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|---|---|
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Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
|
3 score on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Week 4AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
|
2.9 score on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Week 4AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
|
2.4 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Week 4AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
|
1.8 score on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Week 4AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
|
1.43 score on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Week 5AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=12 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
|
3.3 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Week 5AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=12 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
|
3.2 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Week 5AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=12 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
|
2.5 score on a scale
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Week 5AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=12 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
|
1.6 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 5AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Outcome measures
| Measure |
Adult ADHD Patients
n=12 Participants
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.
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.
|
|---|---|
|
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
|
1.58 score on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Week 3AMSES is is an assessment of the smoothness of effect of ADHD medication throughout the day following dosing. The overall smoothness of effect scale is a subscale part of the AMSES that asks participants to respond to "How smooth do you think your medication effect is throughout the day?" on a scale from 0 (never) to 100 (very often). The higher the score, the smoother the medication effect is throughout the day.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
|
|---|---|
|
AMSES - Overall Smoothness of Effect Scale Score
|
69.64 score on a scale
Standard Deviation 14.47
|
SECONDARY outcome
Timeframe: Week 4AMSES is an assessment of the smoothness of effect of ADHD medication throughout the day following dosing. The overall smoothness of effect scale is a subscale part of the AMSES that asks participants to respond to "How smooth do you think your medication effect is throughout the day?" on a scale from 0 (never) to 100 (very often). The higher the score, the smoother the medication effect is throughout the day.
Outcome measures
| Measure |
Adult ADHD Patients
n=14 Participants
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.
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.
|
|---|---|
|
AMSES - Overall Smoothness of Effect Scale Score
|
75 score on a scale
Standard Deviation 21.92
|
SECONDARY outcome
Timeframe: Week 5AMSES is an assessment of the smoothness of effect of ADHD medication throughout the day following dosing. The overall smoothness of effect scale is a subscale part of the AMSES that asks participants to respond to "How smooth do you think your medication effect is throughout the day?" on a scale from 0 (never) to 100 (very often). The higher the score, the smoother the medication effect is throughout the day.
Outcome measures
| Measure |
Adult ADHD Patients
n=12 Participants
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.
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.
|
|---|---|
|
AMSES - Overall Smoothness of Effect Scale Score
|
85.4 score on a scale
Standard Deviation 19.82
|
SECONDARY outcome
Timeframe: Week 2, Week 5The Behavioral Regulation Index (BRI) t-score on the BRIEF-A (Behavior Rating Inventory of Executive Function-Adult Version) is a summary measure of an individual's ability to regulate their behavior and emotions, 50 indicates the population mean with a standard deviation of 10. A t-score of 65 or higher indicates difficulties in behavioral regulation.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
|
|---|---|
|
Change in Behavioral Regulation Index (BRI) T-Score
|
11.9 T-score
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Week 2, Week 5The Metacognition Index (MI) t-score on the BRIEF-A (Behavior Rating Inventory of Executive Function-Adult Version) is a measure of executive function that assesses an individual's ability to initiate, plan, organize, self-monitor, and manage their own cognitive processes, 50 indicates the population mean with a standard deviation of 10. A t-score of 65 or higher indicates difficulties with executive function related to planning, organization, and cognitive self-regulation.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
|
|---|---|
|
Change in Metacognition Index (MI) T-Score
|
22.1 T-score
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: Week 2, Week 5The Global Executive Composite (GEC) t-score on the BRIEF-A (Behavior Rating Inventory of Executive Function-Adult Version) is a summary measure of overall executive function, 50 indicates the population mean with a standard deviation of 10. A t-score of 65 or higher indicates difficulties with executive function in daily life.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
|
|---|---|
|
Change in Global Executive Composite (GEC) T-score
|
19.2 T-score
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Week 2, Week 51-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.
Outcome measures
| Measure |
Adult ADHD Patients
n=15 Participants
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.
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.
|
|---|---|
|
Change in Clinical Global Impression-Severity (CGI-S) Scale Score
|
1.7 score on a scale
Standard Deviation 1
|
Adverse Events
Adult ADHD Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adult ADHD Patients
n=29 participants at risk
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.
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in fingers and hands
|
3.4%
1/29 • 8 weeks
|
|
Nervous system disorders
Headache
|
31.0%
9/29 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.7%
6/29 • 8 weeks
|
|
Nervous system disorders
Insomnia
|
17.2%
5/29 • 8 weeks
|
|
Gastrointestinal disorders
Upset stomach /loose stool
|
6.9%
2/29 • 8 weeks
|
|
Nervous system disorders
Metallic taste
|
3.4%
1/29 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle stiffness
|
3.4%
1/29 • 8 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.4%
1/29 • 8 weeks
|
|
Psychiatric disorders
anxiety
|
24.1%
7/29 • 8 weeks
|
|
Nervous system disorders
intermittent irritability
|
3.4%
1/29 • 8 weeks
|
|
Reproductive system and breast disorders
Menstrual cramps
|
3.4%
1/29 • 8 weeks
|
|
Infections and infestations
common cold
|
6.9%
2/29 • 8 weeks
|
|
Nervous system disorders
fatigue
|
13.8%
4/29 • 8 weeks
|
|
Gastrointestinal disorders
dry mouth
|
6.9%
2/29 • 8 weeks
|
|
Gastrointestinal disorders
decreased appetite
|
6.9%
2/29 • 8 weeks
|
|
General disorders
wisdom teeth pain
|
3.4%
1/29 • 8 weeks
|
|
Cardiac disorders
Increased heart rate
|
13.8%
4/29 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place