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

Phase 3

Completed

• Conditions: ADHD
• Interventions: Drug: KP415 oral capsule

• Registration Number: NCT03460652
• Lead Sponsor: Zevra Therapeutics

Brief Summary

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

Detailed Description

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

* Screening Period: Subjects will undergo a screening period up to 30 days prior to entering the Dose Optimization Phase.

* 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.

* Treatment Phase: Eligible subjects will receive single daily doses of KP415 for up to approximately 360 days (up to approximately 12 months). The dose of KP415 given in the Treatment Phase will be the dose of KP415 at the end of the Dose Optimization Phase. During the Treatment Phase, the dose of KP415 may be changed based on individual tolerability and best dose response (to either 20, 30, or 40 mg KP415 capsules). Safety, efficacy and sleep behavior assessments will be performed.

* 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 Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-09
• Study Start: 2018-03-13
• Primary Completion: 2019-06-20
• Study Completion: 2019-07-09
• Status Verified: 2020-06
• Disposition First Submitted: 2020-06-25
• Results First Submitted: 2021-03-29
• Results First Submitted QC: 2021-06-29
• Disposition First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Results First Posted: 2021-07-19
• Disposition First Posted: 2021-07-19
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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. Subjects who completed the efficacy study with KP415 may be rolled over into the current study.
4. 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.

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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 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.
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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label KP415	KP415 oral capsule	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)

Primary Outcome Measures

Name	Time	Method
Subjects With Treatment-Emergent Adverse Events (TEAEs)	Up to 12 months	TEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in CGI-S	Up to 12 months	The CGI-S is a clinician-rated scale that evaluates the severity of psychopathology (ADHD symptoms in this study) on a scale from 1 (not at all ill) to 7 (among the most severely ill).
Change From Baseline in Children's Sleep Habits Questionnaire	Up to 12 months	The modified, abbreviated Children's Sleep Habits Questionnaire (CSHQ) will be used to assess the sleep behavior. The CSHQ is a retrospective, 33-item parent questionnaire to examine sleep behavior in small children. Items are rated on a 3-point scale of "Usually", "Sometimes" and "Rarely" for occurrences in a number of key sleep domains: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. Scores range from 33-99, with higher scores represent more disturbed sleep. Scores were obtained during a clinician-directed interview with the parent/guardian/caregiver.
Change From Baseline in ADHD-RS-5 Total Score	Up to 12 months	The clinician-administered ADHD-RS-5 is an 18-item scale that rates ADHD symptoms on a 4-point scale. Each item is scored using a combination of severity and frequency ratings from a range of 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of very often), so that the total ADHD-RS-5 scores range from 0 to 54. The 18 items can be divided into two 9-item subscales: One for hyperactivity/impulsivity and the other for inattentiveness.

Trial Locations

Locations (15)

Innovative Clinical Research, Inc.; 🇺🇸 Lauderhill, Florida, United States

MCB Clinical Research Centers; 🇺🇸 Colorado Springs, Colorado, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Memphis, Tennessee, United States

Psychiatric Associates; 🇺🇸 Overland Park, Kansas, United States

Center for Psychiatry and Behavioral Medicine, Inc.; 🇺🇸 Las Vegas, Nevada, United States

Meridien Research; 🇺🇸 Maitland, Florida, United States

Capstone Clinical Research; 🇺🇸 Libertyville, Illinois, United States

Woodland International Research; 🇺🇸 Little Rock, Arkansas, United States

FutureSearch Trials; 🇺🇸 Austin, Texas, United States

Neuro-Behavioral Clinical Research; 🇺🇸 Canton, Ohio, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Bayou City Research, Ltd.; 🇺🇸 Houston, Texas, United States

Oregon Center for Clinical Investigations, Inc.; 🇺🇸 Salem, Oregon, United States

Houston Clinical Trials; 🇺🇸 Houston, Texas, United States

Midwest Clinical Research Center, LLC; 🇺🇸 Dayton, Ohio, United States