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

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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.

Tracking Information
First Submitted Date  ICMJE September 20, 2017
First Posted Date  ICMJE September 26, 2017
Results First Submitted Date  ICMJE March 29, 2021
Results First Posted Date  ICMJE June 30, 2021
Last Update Posted Date June 30, 2021
Actual Study Start Date  ICMJE December 20, 2017
Actual Primary Completion Date May 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2021)
Change From Baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores [ 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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
Change in SKAMP-C Scores [ Time Frame: Across the full classroom day after 7 days of dosing with optimal dose [Day 28] ]
Average change from baseline of the SKAMP-C scores compared to placebo
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2021)
Change From Baseline in Permanent Product Measure of Performance (PERMP) Rating Scale, Number of Problems Attempted (PERMP-A) [ 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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
Change in PERMP Scores [ Time Frame: Across the full classroom day after 7 days of dosing with optimal dose [Day 28] ]
Average change from baseline of PERMP scores compared to placebo
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE KP415 Classroom Study in Children (6-12 Years of Age) With ADHD
Official Title  ICMJE A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy Laboratory Classroom Study With KP415 in Children With Attention-Deficit/Hyperactivity Disorder
Brief Summary The study is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy laboratory classroom study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).
Detailed Description

The study will consist of a Screening Period, an Open-Label Dose Optimization Phase, a Double-Blind Treatment Phase and a Follow-Up Visit, as follows:

  • Screening Period: Subjects will undergo a screening period up to 49 days prior to entering into the Open-Label Dose Optimization Phase.
  • Open-Label Dose Optimization Phase: During the Dose Optimization Phase, subjects will be titrated to doses of 20, 30 or 40 mg KP415 based on tolerability and best individual dose-response in the opinion of the Investigator.
  • Double-Blind Treatment Phase: Eligible subjects will be randomized to receive single daily doses of KP415 or Placebo for 7 days according to a randomization schedule. The dose of KP415 given in the Treatment Phase will be the same as the optimized dose of KP415 at the end of the Dose Optimization Phase. All subjects will receive their assigned treatment daily for 7 days. The dose will be the same at each day of the Treatment Period. Efficacy and safety assessments will be performed after the last dose of the Treatment Period.
  • Follow-Up Visit: 3 ±2 days after administration of the last dose of the Treatment Phase, subjects will enter a Follow-Up Visit to evaluate safety parameters.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
3-week, open-label dose-optimization phase followed by a 1-week randomized, double-blind treatment phase
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE
  • Drug: KP415 oral capsule
    Daily dose
  • Drug: Placebo oral capsule
    Daily dose
Study Arms  ICMJE
  • Experimental: Double-blind KP415

    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)

    Intervention: Drug: KP415 oral capsule
  • Placebo Comparator: Double-blind Placebo
    Placebo oral capsule
    Intervention: Drug: Placebo oral capsule
  • Experimental: Open-Label KP415

    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)

    Intervention: Drug: KP415 oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2021)
155
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2017)
140
Actual Study Completion Date  ICMJE May 16, 2018
Actual Primary Completion Date May 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) per clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
  2. Subject must have a score of at least 3 (mildly ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale.
  3. Subject, subject's parent/legal guardian and caregiver (if applicable) must understand and be willing and able to comply with all study procedures and visit schedule.

Exclusion Criteria:

  1. Subject with any clinically significant chronic medical condition that may interfere with the participant's ability to participate in the study.
  2. Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances.
  3. Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood, or history of persistent neurological symptoms attributable to serious head injury.
  4. Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible.
  5. Subject has any history of attempted suicide or clinically significant suicidal ideation or subject has a C-SSRS score for suicidal ideation ≥2.
  6. Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism, or excretion of study drug.
  7. Subject has a history or presence of abnormal ECGs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03292952
Other Study ID Numbers  ICMJE KP415.E01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party KemPharm, Inc.
Study Sponsor  ICMJE KemPharm, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott H Kollins, PhD Duke Clinical Research Institute
PRS Account KemPharm, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP