Status:
COMPLETED
KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD
Lead Sponsor:
Zevra Therapeutics
Conditions:
ADHD
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2019
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT03460652
Start Date
March 13 2018
End Date
July 9 2019
Last Update
July 19 2021
Active Locations (19)
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1
Woodland International Research
Little Rock, Arkansas, United States, 72211
2
MCB Clinical Research Centers
Colorado Springs, Colorado, United States, 80910
3
Meridien Research
Bradenton, Florida, United States, 34201
4
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256