Trial Outcomes & Findings for KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (NCT NCT03292952)
NCT ID: NCT03292952
Last Updated: 2021-06-30
Results Overview
The SKAMP scale is a validated rating of subjective impairment of classroom behaviors in children with ADHD. It comprises 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment) by trained study personnel (Swanson 1998). The SKAMP-C score was obtained by summing the rating values for each of the 13 items (range: 0-78), with higher scores indicating greater impairment.
COMPLETED
PHASE3
155 participants
Average of all time points during the full laboratory classroom day, which occurred on Day 7 (Day 28 of the overall study) of the Treatment Phase
2021-06-30
Participant Flow
Participant milestones
| Measure |
Open-Label KP415
Open-label titration with KP415 capsule 20, 30, or 40 mg once-daily for 3 weeks
|
Double-Blind KP415
KP415 oral capsule 20, 30 or 40 mg
KP415 oral capsule: Daily dose
|
Double-Blind Placebo
Placebo oral capsule
Placebo oral capsule: Daily dose
|
|---|---|---|---|
|
Open-Label Dose Optimization
STARTED
|
155
|
0
|
0
|
|
Open-Label Dose Optimization
COMPLETED
|
150
|
0
|
0
|
|
Open-Label Dose Optimization
NOT COMPLETED
|
5
|
0
|
0
|
|
Double-Blind Treatment Phase
STARTED
|
0
|
74
|
76
|
|
Double-Blind Treatment Phase
COMPLETED
|
0
|
74
|
75
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
KP415 Classroom Study in Children (6-12 Years of Age) With ADHD
Baseline characteristics by cohort
| Measure |
Active Treatment
n=74 Participants
KP415 oral capsule 20, 30 or 40 mg
KP415 oral capsule: Daily dose
|
Placebo Treatment
n=76 Participants
Placebo oral capsule
Placebo oral capsule: Daily dose
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.6 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
9.6 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
76 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average of all time points during the full laboratory classroom day, which occurred on Day 7 (Day 28 of the overall study) of the Treatment PhaseThe SKAMP scale is a validated rating of subjective impairment of classroom behaviors in children with ADHD. It comprises 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment) by trained study personnel (Swanson 1998). The SKAMP-C score was obtained by summing the rating values for each of the 13 items (range: 0-78), with higher scores indicating greater impairment.
Outcome measures
| Measure |
Active Treatment
n=74 Participants
KP415 oral capsule 20, 30 or 40 mg
KP415 oral capsule: Daily dose
|
Placebo Treatment
n=75 Participants
Placebo oral capsule
Placebo oral capsule: Daily dose
|
|---|---|---|
|
Change From Baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores
|
-4.87 score on a scale
Standard Error 0.62
|
0.536 score on a scale
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Average of all time points during the full laboratory classroom day, which occurred on Day 7 (Day 28 of the overall study) of the Treatment PhaseThe PERMP is an adjusted math test designed to assess attention in children with ADHD (Swanson 1999). The test measures attention through a subject's ability to initiate, self-monitor, and complete the math test. A Placement PERMP was performed early in the trial to assure that subjects could complete at least the basic level of math problems and to determine the appropriate level of math to be assigned during the remainder of the study. The PERMP is an individually calibrated 5-page mathematics worksheet consisting of 400 problems. PERMP-A scores document the number of problems attempted, from 0 to 400, and thus higher scores represent a better outcome.
Outcome measures
| Measure |
Active Treatment
n=74 Participants
KP415 oral capsule 20, 30 or 40 mg
KP415 oral capsule: Daily dose
|
Placebo Treatment
n=75 Participants
Placebo oral capsule
Placebo oral capsule: Daily dose
|
|---|---|---|
|
Change From Baseline in Permanent Product Measure of Performance (PERMP) Rating Scale, Number of Problems Attempted (PERMP-A)
|
25.82 score on a scale
Standard Error 3.44
|
2.25 score on a scale
Standard Error 3.05
|
Adverse Events
Open-Label KP415
Double-Blind KP415
Double-Blind Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-Label KP415
n=155 participants at risk
3-week titration period to identify an optimal dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule, once-daily:
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)
|
Double-Blind KP415
n=74 participants at risk
Optimized dose of KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule, once-daily:
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)
|
Double-Blind Placebo
n=76 participants at risk
Double-Blind Placebo, once-daily
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
7.7%
12/155 • 5 weeks
|
5.4%
4/74 • 5 weeks
|
1.3%
1/76 • 5 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.7%
15/155 • 5 weeks
|
4.1%
3/74 • 5 weeks
|
1.3%
1/76 • 5 weeks
|
|
Psychiatric disorders
Insomnia
|
15.5%
24/155 • 5 weeks
|
2.7%
2/74 • 5 weeks
|
1.3%
1/76 • 5 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/155 • 5 weeks
|
2.7%
2/74 • 5 weeks
|
0.00%
0/76 • 5 weeks
|
|
Psychiatric disorders
Affect lability
|
11.6%
18/155 • 5 weeks
|
1.4%
1/74 • 5 weeks
|
1.3%
1/76 • 5 weeks
|
|
Psychiatric disorders
Irritability
|
7.7%
12/155 • 5 weeks
|
0.00%
0/74 • 5 weeks
|
0.00%
0/76 • 5 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.5%
38/155 • 5 weeks
|
0.00%
0/74 • 5 weeks
|
0.00%
0/76 • 5 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
6/155 • 5 weeks
|
1.4%
1/74 • 5 weeks
|
1.3%
1/76 • 5 weeks
|
|
Nervous system disorders
Dizziness
|
2.6%
4/155 • 5 weeks
|
0.00%
0/74 • 5 weeks
|
0.00%
0/76 • 5 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
6/155 • 5 weeks
|
2.7%
2/74 • 5 weeks
|
5.3%
4/76 • 5 weeks
|
|
Gastrointestinal disorders
Fatigue
|
2.6%
4/155 • 5 weeks
|
0.00%
0/74 • 5 weeks
|
0.00%
0/76 • 5 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place