Trial Outcomes & Findings for KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD (NCT NCT03460652)
NCT ID: NCT03460652
Last Updated: 2021-07-19
Results Overview
TEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit.
COMPLETED
PHASE3
282 participants
Up to 12 months
2021-07-19
Participant Flow
Participant milestones
| Measure |
Active Treatment
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:
28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)
|
|---|---|
|
Overall Study
STARTED
|
282
|
|
Overall Study
Entered Treatment Phase
|
238
|
|
Overall Study
COMPLETED
|
155
|
|
Overall Study
NOT COMPLETED
|
127
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD
Baseline characteristics by cohort
| Measure |
Active Treatment
n=238 Participants
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:
28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)
|
|---|---|
|
Age, Continuous
|
9.1 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
193 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsTEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit.
Outcome measures
| Measure |
Treatment-Phase Safety Population
n=238 Participants
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:
28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)
|
|---|---|
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Subjects With Treatment-Emergent Adverse Events (TEAEs)
Subjects with at least 1 TEAE
|
143 Participants
|
|
Subjects With Treatment-Emergent Adverse Events (TEAEs)
Subjects with a related TEAE
|
108 Participants
|
|
Subjects With Treatment-Emergent Adverse Events (TEAEs)
Subjects with a TEAE leading to discontinuation of study drug
|
6 Participants
|
|
Subjects With Treatment-Emergent Adverse Events (TEAEs)
Subjects with an SAE
|
2 Participants
|
|
Subjects With Treatment-Emergent Adverse Events (TEAEs)
Subjects with an AE leading to death
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsThe clinician-administered ADHD-RS-5 is an 18-item scale that rates ADHD 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-5 scores range from 0 to 54. The 18 items can be divided into two 9-item subscales: One for hyperactivity/impulsivity and the other for inattentiveness.
Outcome measures
| Measure |
Treatment-Phase Safety Population
n=225 Participants
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:
28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)
|
|---|---|
|
Change From Baseline in ADHD-RS-5 Total Score
|
-29.0 score on a scale
Standard Deviation 11.21
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The Overall Efficacy Population was comprised of 225 subjects. Due to early terminations, 223 subjects remained at Visit 6 (Day 30) and 153 subjects remained at Visit 17 (Day 360)
The CGI-S is a clinician-rated scale that evaluates the severity of psychopathology (ADHD symptoms in this study) on a scale from 1 (not at all ill) to 7 (among the most severely ill).
Outcome measures
| Measure |
Treatment-Phase Safety Population
n=225 Participants
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:
28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)
|
|---|---|
|
Change From Baseline in CGI-S
Baseline (Visit 2 for new subjects and Visit 5 for roll-over subjects) · 1 = Normal, not at all
|
0 Participants
|
|
Change From Baseline in CGI-S
Baseline (Visit 2 for new subjects and Visit 5 for roll-over subjects) · 2 = Borderline mentally ill
|
0 Participants
|
|
Change From Baseline in CGI-S
Baseline (Visit 2 for new subjects and Visit 5 for roll-over subjects) · 3 = Mildly ill
|
5 Participants
|
|
Change From Baseline in CGI-S
Baseline (Visit 2 for new subjects and Visit 5 for roll-over subjects) · 4 = Moderately ill
|
82 Participants
|
|
Change From Baseline in CGI-S
Baseline (Visit 2 for new subjects and Visit 5 for roll-over subjects) · 5 = Markedly ill
|
112 Participants
|
|
Change From Baseline in CGI-S
Baseline (Visit 2 for new subjects and Visit 5 for roll-over subjects) · 6 = Severely ill
|
26 Participants
|
|
Change From Baseline in CGI-S
Baseline (Visit 2 for new subjects and Visit 5 for roll-over subjects) · 7 = Among the most extremely ill patients
|
0 Participants
|
|
Change From Baseline in CGI-S
Visit 17 (Day 360) · 1 = Normal, not at all
|
47 Participants
|
|
Change From Baseline in CGI-S
Visit 17 (Day 360) · 2 = Borderline mentally ill
|
45 Participants
|
|
Change From Baseline in CGI-S
Visit 17 (Day 360) · 3 = Mildly ill
|
52 Participants
|
|
Change From Baseline in CGI-S
Visit 17 (Day 360) · 4 = Moderately ill
|
7 Participants
|
|
Change From Baseline in CGI-S
Visit 17 (Day 360) · 5 = Markedly ill
|
1 Participants
|
|
Change From Baseline in CGI-S
Visit 17 (Day 360) · 6 = Severely ill
|
1 Participants
|
|
Change From Baseline in CGI-S
Visit 17 (Day 360) · 7 = Among the most extremely ill patients
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsThe modified, abbreviated Children's Sleep Habits Questionnaire (CSHQ) will be used to assess the sleep behavior. The CSHQ is a retrospective, 33-item parent questionnaire to examine sleep behavior in small children. Items are rated on a 3-point scale of "Usually", "Sometimes" and "Rarely" for occurrences in a number of key sleep domains: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. Scores range from 33-99, with higher scores represent more disturbed sleep. Scores were obtained during a clinician-directed interview with the parent/guardian/caregiver.
Outcome measures
| Measure |
Treatment-Phase Safety Population
n=228 Participants
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:
28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)
|
|---|---|
|
Change From Baseline in Children's Sleep Habits Questionnaire
|
-4.3 score on a scale
Standard Deviation 5.20
|
Adverse Events
Active Treatment
Serious adverse events
| Measure |
Active Treatment
n=238 participants at risk
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:
28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
exacerbation of asthma
|
0.42%
1/238 • Number of events 7 • 1 year
|
|
Nervous system disorders
seizure
|
0.42%
1/238 • Number of events 1 • 1 year
|
|
Psychiatric disorders
aggression
|
0.42%
1/238 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Active Treatment
n=238 participants at risk
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:
28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)
|
|---|---|
|
Psychiatric disorders
psychiatric disorders
|
23.1%
55/238 • 1 year
|
|
Infections and infestations
infections and infestations
|
28.2%
67/238 • 1 year
|
|
Metabolism and nutrition disorders
metabolism and nutrition disorders
|
19.3%
46/238 • 1 year
|
|
Investigations
investigations
|
13.9%
33/238 • 1 year
|
|
Gastrointestinal disorders
gastrointestinal disorders
|
8.0%
19/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
respiratory, thoracic and mediastinal disorders
|
6.3%
15/238 • 1 year
|
|
Nervous system disorders
nervous system
|
8.4%
20/238 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place