Status:
COMPLETED
KP415 Classroom 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
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 Disor...
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 scre...
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.
- 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 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.
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2018
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT03292952
Start Date
December 20 2017
End Date
May 16 2018
Last Update
June 30 2021
Active Locations (5)
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1
Meridien Research
Bradenton, Florida, United States, 34201
2
Meridien Research
Maitland, Florida, United States, 32751
3
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
4
Duke University Medical Center
Durham, North Carolina, United States, 27705