KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD
NCT ID: NCT03460652
Last Updated: 2021-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
282 participants
INTERVENTIONAL
2018-03-13
2019-07-09
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-Label KP415
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)
KP415 oral capsule
Once-daily oral dose
Interventions
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KP415 oral capsule
Once-daily oral dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
6 Years
12 Years
ALL
No
Sponsors
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Zevra Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Childress, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Psychiatry And Behavioral Medicine Inc.
Locations
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Woodland International Research
Little Rock, Arkansas, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Meridien Research
Bradenton, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Meridien Research
Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Psychiatric Associates
Overland Park, Kansas, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Neuro-Behavioral Clinical Research
Canton, Ohio, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Houston Clinical Trials
Houston, Texas, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KP415.S01
Identifier Type: -
Identifier Source: org_study_id
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