Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03292952
Previous Study | Return to List | Next Study

KP415 Classroom Study in Children (6-12 Years of Age) With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03292952
Recruitment Status : Completed
First Posted : September 26, 2017
Results First Posted : June 30, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
KemPharm, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition ADHD
Interventions Drug: KP415 oral capsule
Drug: Placebo oral capsule
Enrollment 155
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-Label KP415 Double-Blind KP415 Double-Blind Placebo
Hide Arm/Group Description Open-label titration with KP415 capsule 20, 30, or 40 mg once-daily for 3 weeks

KP415 oral capsule 20, 30 or 40 mg

KP415 oral capsule: Daily dose

Placebo oral capsule

Placebo oral capsule: Daily dose

Period Title: Open-Label Dose Optimization
Started 155 0 [1] 0 [1]
Completed 150 0 0
Not Completed 5 0 0
[1]
All subjects were treated with open-label KP415 during the Open-Label Phase
Period Title: Double-Blind Treatment Phase
Started 0 [1] 74 76
Completed 0 74 75
Not Completed 0 0 1
[1]
Subjects were randomized to the double-blind Treatment Phase after Open-Label Dose Optimization
Arm/Group Title Active Treatment Placebo Treatment Total
Hide Arm/Group Description

KP415 oral capsule 20, 30 or 40 mg

KP415 oral capsule: Daily dose

Placebo oral capsule

Placebo oral capsule: Daily dose

Total of all reporting groups
Overall Number of Baseline Participants 74 76 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 76 participants 150 participants
9.6  (1.6) 9.6  (1.5) 9.6  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 76 participants 150 participants
Female
30
  40.5%
28
  36.8%
58
  38.7%
Male
44
  59.5%
48
  63.2%
92
  61.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 76 participants 150 participants
Hispanic or Latino
20
  27.0%
20
  26.3%
40
  26.7%
Not Hispanic or Latino
54
  73.0%
56
  73.7%
110
  73.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 76 participants 150 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   6.8%
2
   2.6%
7
   4.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
25
  33.8%
31
  40.8%
56
  37.3%
White
38
  51.4%
38
  50.0%
76
  50.7%
More than one race
6
   8.1%
4
   5.3%
10
   6.7%
Unknown or Not Reported
0
   0.0%
1
   1.3%
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 74 participants 76 participants 150 participants
74 76 150
1.Primary Outcome
Title Change From Baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Treatment Placebo Treatment
Hide Arm/Group Description:

KP415 oral capsule 20, 30 or 40 mg

KP415 oral capsule: Daily dose

Placebo oral capsule

Placebo oral capsule: Daily dose

Overall Number of Participants Analyzed 74 75
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.87  (0.62) 0.536  (0.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Permanent Product Measure of Performance (PERMP) Rating Scale, Number of Problems Attempted (PERMP-A)
Hide Description The 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Double-Blind KP415 Double-Blind Placebo
Hide Arm/Group Description:

KP415 oral capsule 20, 30 or 40 mg

KP415 oral capsule: Daily dose

Placebo oral capsule

Placebo oral capsule: Daily dose

Overall Number of Participants Analyzed 74 75
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
25.82  (3.44) 2.25  (3.05)
Time Frame 5 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-Label KP415 Double-Blind KP415 Double-Blind Placebo
Hide Arm/Group Description

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)

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, once-daily
All-Cause Mortality
Open-Label KP415 Double-Blind KP415 Double-Blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/155 (0.00%)   0/74 (0.00%)   0/76 (0.00%) 
Hide Serious Adverse Events
Open-Label KP415 Double-Blind KP415 Double-Blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/155 (0.00%)   0/74 (0.00%)   0/76 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Open-Label KP415 Double-Blind KP415 Double-Blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   104/155 (67.10%)   13/74 (17.57%)   6/76 (7.89%) 
Gastrointestinal disorders       
Abdominal pain upper   15/155 (9.68%)  3/74 (4.05%)  1/76 (1.32%) 
Vomiting   6/155 (3.87%)  1/74 (1.35%)  1/76 (1.32%) 
Fatigue   4/155 (2.58%)  0/74 (0.00%)  0/76 (0.00%) 
Infections and infestations       
Pharyngitis   0/155 (0.00%)  2/74 (2.70%)  0/76 (0.00%) 
Upper respiratory tract infection   6/155 (3.87%)  2/74 (2.70%)  4/76 (5.26%) 
Metabolism and nutrition disorders       
Decreased appetite   38/155 (24.52%)  0/74 (0.00%)  0/76 (0.00%) 
Nervous system disorders       
Headache   12/155 (7.74%)  4/74 (5.41%)  1/76 (1.32%) 
Dizziness   4/155 (2.58%)  0/74 (0.00%)  0/76 (0.00%) 
Psychiatric disorders       
Insomnia   24/155 (15.48%)  2/74 (2.70%)  1/76 (1.32%) 
Affect lability   18/155 (11.61%)  1/74 (1.35%)  1/76 (1.32%) 
Irritability   12/155 (7.74%)  0/74 (0.00%)  0/76 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerald Orehostky
Organization: KemPharm
Phone: 321-250-3699
EMail: gorehostky@kempharm.com
Layout table for additonal information
Responsible Party: KemPharm, Inc.
ClinicalTrials.gov Identifier: NCT03292952    
Other Study ID Numbers: KP415.E01
First Submitted: September 20, 2017
First Posted: September 26, 2017
Results First Submitted: March 29, 2021
Results First Posted: June 30, 2021
Last Update Posted: June 30, 2021