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



Status:Recruiting
Conditions:Psychiatric, ADHD
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:6 - 12
Updated:4/22/2018
Start Date:March 13, 2018
End Date:March 2019
Contact:Jenn Gargione
Email:jenn.gargione@premier-research.com
Phone:267-536-3561

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A Multicenter, Dose-Optimized, Open-Label Safety Study With KP415 in Children With Attention-Deficit/Hyperactivity Disorder

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

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.

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.

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.
We found this trial at
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Houston, Texas 77098
Principal Investigator: Alain Katic, MD
Phone: 713-527-8448
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Austin, Texas 78731
Principal Investigator: Michael Downing, MD
Phone: 214-369-2600
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Berlin, New Jersey
Principal Investigator: Howard Hassman, MD
Phone: 856-753-7335
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Bradenton, Florida
Principal Investigator: Andrew Cutler, MD
Phone: 941-756-8680
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Canton, Ohio 44718
Principal Investigator: Shishuka Malhotra, MD
Phone: 330-493-1118
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Colorado Springs, Colorado 80910
Principal Investigator: Andrew Sedillo, MD
Phone: 719-634-6576
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Dayton, Ohio 45408
Principal Investigator: Otto Dueno, MD
Phone: 937-424-1050
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Houston, Texas 77024
Principal Investigator: Matthew Brams, MD
Phone: 832-251-7000
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Jacksonville, Florida 32216
Principal Investigator: Nandita Jones, MD
Phone: 904-281-5757
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Las Vegas, Nevada 89128
Principal Investigator: Ann Childress, MD
Phone: 702-838-0742
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Lauderhill, Florida 33319
Principal Investigator: Rishi Kakar, MD
Phone: 954-990-6326
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Libertyville, Illinois 60048
Principal Investigator: Michael Greenbaum, MD
Phone: 847-549-7214
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Little Rock, Arkansas 72211
Principal Investigator: Jim Aukstuolis, MD
Phone: 501-221-8681
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Maitland, Florida 32751
Principal Investigator: Andrea Marraffino, MD
Phone: 407-644-1165
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Memphis, Tennessee 38119
Principal Investigator: Valerie Arnold, MD
Phone: 901-843-1045
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Orlando, Florida 32806
Principal Investigator: Robert Molpus, MD
Phone: 407-425-5100
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Overland Park, Kansas 66211
Principal Investigator: William Murphy, MD
Phone: 913-438-8221
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Portland, Oregon 97210
Principal Investigator: Beal Essink, MD
Phone: 503-276-6224
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Salem, Oregon 97301
Principal Investigator: Drissana Tran, MD
Phone: 503-540-0100
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