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

NCT03292952 | Completed Phase 3 Results FDA Drug

• 1 other identifier: KP415.E01
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 5

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).

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores

  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.

  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

Secondary Outcomes (1)

• Change From Baseline in Permanent Product Measure of Performance (PERMP) Rating Scale, Number of Problems Attempted (PERMP-A)

  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

Study Arms (3)

Double-blind KP415

EXPERIMENTAL

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)

Drug: KP415 oral capsule

Double-blind Placebo

PLACEBO COMPARATOR

Placebo oral capsule

Drug: Placebo oral capsule

Open-Label KP415

EXPERIMENTAL

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)

Drug: KP415 oral capsule

Interventions

KP415 oral capsule DRUG

Daily dose

Double-blind KP415; Open-Label KP415

Placebo oral capsule DRUG

Daily dose

Double-blind Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• Subject must have a score of at least 3 (mildly ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale.
• 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.

You may not qualify if:

• Subject with any clinically significant chronic medical condition that may interfere with the participant's ability to participate in the study.
• 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.
• 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.
• 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.
• Subject has any history of attempted suicide or clinically significant suicidal ideation or subject has a C-SSRS score for suicidal ideation ≥2.
• 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.
• Subject has a history or presence of abnormal ECGs.

Sponsors & Collaborators

• Zevra Therapeutics: lead

Study Sites (5)

Meridien Research

Bradenton, Florida, 34201, United States

Location

Meridien Research

Maitland, Florida, 32751, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Bayou City Research, Ltd.

Houston, Texas, 77007, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Gerald Orehostky
• Organization: KemPharm

gorehostky@kempharm.com

321-250-3699

Study Officials

• Scott H Kollins, PhD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3-week, open-label dose-optimization phase followed by a 1-week randomized, double-blind treatment phase

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 26, 2017
• Study Start: December 20, 2017
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)