KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD

NCT03460652 | Completed Phase 3 Results FDA Drug

• 1 other identifier: KP415.S01
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 19

Brief Summary

This study is a multicenter, dose-optimized, open-label safety study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Subjects With Treatment-Emergent Adverse Events (TEAEs)

  TEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit.

  Up to 12 months

Secondary Outcomes (3)

• Change From Baseline in ADHD-RS-5 Total Score

  Up to 12 months

• Change From Baseline in CGI-S

  Up to 12 months

• Change From Baseline in Children's Sleep Habits Questionnaire

  Up to 12 months

Study Arms (1)

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

Once-daily oral dose

Also known as: Azstarys, SDX/d-MPH

Open-Label KP415

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.
• Subjects who completed the efficacy study with KP415 may be rolled over into the current study.
• 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 clinically significant suicidal ideation/behavior, based on a history of attempted suicide and the C-SSRS assessment at Screening or at any time before the last dose of study drug.
• 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 (19)

Woodland International Research

Little Rock, Arkansas, 72211, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Meridien Research

Bradenton, Florida, 34201, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Innovative Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

Meridien Research

Maitland, Florida, 32751, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Neuro-Behavioral Clinical Research

Canton, Ohio, 44718, United States

Location

Midwest Clinical Research Center, LLC

Dayton, Ohio, 45417, United States

Location

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, 97214, United States

Location

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, 97301, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials

Austin, Texas, 78731, United States

Location

Bayou City Research, Ltd.

Houston, Texas, 77007, United States

Location

Houston Clinical Trials

Houston, Texas, 77098, United States

Location

Related Publications (2)

• Childress AC, Cutler AJ, Patel M, Oh C. Analysis of Growth Velocity in Children with Attention-Deficit/Hyperactivity Disorder Treated for up to 12 Months with Serdexmethylphenidate/Dexmethylphenidate. J Child Adolesc Psychopharmacol. 2023 May;33(4):134-142. doi: 10.1089/cap.2023.0012.

  PMID: 37204277 DERIVED

• Childress AC, Marraffino A, Cutler AJ, Oh C, Brams MN. Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. J Child Adolesc Psychopharmacol. 2023 Mar;33(2):51-58. doi: 10.1089/cap.2022.0076. Epub 2023 Feb 20.

  PMID: 36809150 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

serdexmethylphenidate and dexmethylphenidate

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

• Ann Childress, MD

  Center for Psychiatry And Behavioral Medicine Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 9, 2018
• Study Start: March 13, 2018
• Primary Completion: June 20, 2019
• Study Completion: July 9, 2019
• Last Updated: July 19, 2021
• Results First Posted: July 19, 2021

Record last verified: 2020-06

Locations

US (19)