search
Back to results

An Efficacy and Safety Study w/ Azstarys® in Children With ADHD (KP415P01)

Primary Purpose

Attention Deficit/Hyperactivity Disorder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
placebo
Sponsored by
Corium, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: In Cohort 1, subjects must be at least 4 years old and less than 5 years and 10 months at Screening; in Cohort 2, subjects must be at least 6 years old and less than 12 years and 10 months at Screening. Subjects must have a body weight within the 5th and 95th percentile according to the gender-specific weight-for-age percentile charts from the Centers for Disease Control and Prevention (CDC). See calculator at https://www.infantchart.com/child/. Female subjects must agree, if they are of childbearing potential at Screening or when they become of childbearing potential during the study, to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 14 days after the last dose of study drug. Childbearing potential is defined as follows: Girls under the age of 12 who have not had their first period will be considered "not of child-bearing potential." Girls 12 years of age (including girls who will become 13 years during the study) will be considered "of child-bearing potential," even if they have not yet had their first period. Irrespective of age, girls who have had their first period, will be considered "of child-bearing potential." Subjects must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical examinations, vital signs, electrocardiograms (ECGs), medical history, and clinical laboratory values (chemistry, hematology, urinalysis) at Screening. If any of the chemistry or hematology tests are not within the laboratory's reference range, then the subject can be included only if the Investigator determines the deviations to be not clinically relevant. At least one parent/legal guardian of the subject must voluntarily give written permission for him/her to participate in the study. Subjects in Cohort 2 must give written or verbal assent prior to study participation. For verbal assent, the procedure will be documented and signed by a witness. A parent or guardian may not be the witness for a child's verbal assent document. 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 Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid). Subject has had ADHD symptoms present for at least 6 months prior to the Screening Visit. Subject must be able and willing to wash out current stimulant ADHD medications, including herbal medications, from 5 days prior to the start of the Treatment Period, and abstain from taking these to the end of Visit 6 or ET; and wash out non-stimulant ADHD medications from 14 days prior to the start of the Treatment Period, and abstain from taking these to the end of Visit 6. Subject must have a score of ≥4 (Moderately Ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale. For subjects requiring washout of ADHD medications, this criterion refers to a score following washout. Subjects must have age and sex adjusted ratings of ≥90th percentile Total Score on the ADHD-Rating Scale (ADHD-RS) rated over the past 6 months (for 4- and 5-year old children, use Preschool Version of ADHD-RS-IV; for 6-12 years old children, use ADHD-RS-5). Subject functions at an age-appropriate level intellectually, as determined by the Investigator. Subject must have a systolic and diastolic blood pressure below the 95th percentile for age and gender according to the 2017 AAP guidelines (Flynn 2017) based on the average of 3 measurements 2-5 minutes apart. 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. Subject, parent/legal guardian, and caregiver (if applicable) must be able to speak and understand English or Spanish and be able to communicate satisfactorily with the Investigator and study coordinator. Exclusion Criteria: If female, must not be pregnant or breastfeeding, and if of childbearing potential, must have a negative urine pregnancy test at the start of the Screening Period. In addition, a positive pregnancy test before the last dose of study drug will result in early termination from the study. Subject with any clinically significant chronic medical condition that, in the judgment of the Investigator, 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. Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment, and, in the opinion of the Investigator, the ODD is mild to moderate, and eligible subjects with ODD are appropriate and cooperative during Screening. Subject has generalized anxiety disorder or panic disorder that has been the primary focus of treatment at any time during the 12 months prior to Screening or that has required pharmacotherapy any time during the 6 months prior to Screening. Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, depression, vascular disorder, potential CNS-related disorders that might occur in childhood (e.g., Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury. Subject taking anticonvulsants for seizure control or antidepressants currently or within the past 2 years before Screening are not eligible for study participation. A past history of febrile seizure or drug-induced seizure is allowed. Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, ODD, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Subjects allowed to enroll with any of these DSM disorders will require written justification from the Investigator documenting why the conditions will not interfere with participation and to emphasize that ADHD is the primary indication. In the opinion of the Investigator, subject has clinically significant suicidal ideation/behavior, based on history of attempted suicide and the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment at Screening. Subject has any clinically significant unstable medical abnormality, chronic disease (including asthma or diabetes), or a history of a clinically significant abnormality of the cardiovascular (including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension), gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with absorption, distribution, metabolism, or excretion of study drug. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the medical monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during Screening. Subject has a history or presence of abnormal ECGs, which in the Investigator's opinion is clinically significant. Subject has a history of, or currently has, a malignancy. Subject has uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone (TSH) ≤0.8 x the lower limit of normal (LLN) or ≥1.25 x the upper limit of normal (ULN) for the reference laboratory at Screening. Subject has greater than trace proteinuria in the urinalysis at Screening. Subjects with greater than trace proteinuria in the urinalysis at Screening but with a urine protein to creatinine (UP/C) ratio <0.2 in a first morning void urine sample will not be excluded from enrollment. Subjects has a current or recent (past 12 months) history of drug abuse; or current or recent history of drug abuse in someone living in the subject's home, or are using or planning to use prohibited drugs during the trial as specified in the protocol. Subject has a positive urine drug screen at Screening. Subjects with a positive methylphenidate (MPH) urine drug screen may be allowed to continue in the study, provided that the Investigator determines that the positive test is a result of taking prescribed medications and subject is willing to wash out the current medication as required. Subject has participated in any other clinical study with an investigational drug/product within 30 days or at least 5 half-lives, whichever is longer, prior to Screening. Subject has taken ADHD medications from more than one class within 30 days prior to Screening. Subjects on a stable dose of one ADHD medication with occasional use of ADHD medications from another class are eligible at the discretion of the Investigator. Subjects with demonstrated lack of response or intolerability to adequate dose and duration of treatment with MPH products. Judgment of adequate dose and duration is at the discretion of the Investigator. Subject has a positive urine MPH screen by dipstick (e.g., NarcoCheck®) at Visit 2. Subject is planning to initiate psychotherapy during the study (subjects participating in psychotherapy beginning at least 4 weeks before study initiation are permitted to continue). Subject has a history of severe allergies or adverse drug reactions to more than one class of medications. Subject has a history of allergic reaction or a known or suspected sensitivity to MPH or any substance that is contained in the study drug. Subject, parent/legal guardian, and caregiver (if applicable, at the Investigator's discretion) has commitments during the study that would interfere with attending study visits. Subject or subject's family anticipates a move outside the geographic range of the investigative site during the study period, or plans extended travel inconsistent with the recommended visit interval during study duration. Subject has one or more siblings living in the same household who are enrolled in this or another clinical drug trial. Subject shows evidence of current physical, sexual, or emotional abuse. Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.

Sites / Locations

  • Preferred Research Partners (PRP)Recruiting
  • IMMUNOe International Research centerRecruiting
  • Vertex Research Group incRecruiting
  • Clinical Neuroscience Solutions- OrlandoRecruiting
  • Accel Research SitesRecruiting
  • Accel Research SitesRecruiting
  • South Florida Research Phase I-IV INCRecruiting
  • CNS HealthcareRecruiting
  • Sky Clinical Research Network Group P.CRecruiting
  • iResearch AtlantaRecruiting
  • CenExel iResearch, LLCRecruiting
  • DelRicht Research- Touro Medical CenterRecruiting
  • St. Charles Psychiatric Associates & Midwest Research GroupRecruiting
  • Boeson researchRecruiting
  • Alivation Research, LLCRecruiting
  • Center for Psychiatry and Behavioral Medicine IncRecruiting
  • Dayton Clinical ResearchRecruiting
  • IPS Research Company, Inc.Recruiting
  • Clinical Nueroscience Solution, IncRecruiting
  • Houston Clinical TrialsRecruiting
  • AIM TrialsRecruiting
  • Flourish ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cohort 1: SDX/d-MPH in 4-5 year old

Cohort 1: Placebo in 4-5 year old

Cohort 2: SDX/d-MPH in 6-12 year old

Cohort 2: Placebo in 6-12 year old

Arm Description

13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH

matching placebo

26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH

matching placebo

Outcomes

Primary Outcome Measures

A comparison of the change in mean ADHD Rating Scale (ADHD-RS) results from baseline to end of treatment between active and placebo treatments.
The ADHD-RS is an 18-item scale based on Diagnostic and Statistical Manual of Mental Disorders criteria of ADHD that rates 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 scores range from 0 to 54. Scores will be obtained during a clinician-directed interview with the parent/guardian/caregiver at each visit.

Secondary Outcome Measures

A comparison of the change in mean Clinical Global Impressions-Severity (CGI-S) results from baseline to end of treatment between active and placebo treatments.
The CGI-S is a clinician-rated scale that evaluates the severity of psychopathology (ADHD symptoms in the study) on a scale from 1 (not at all ill) to 7 (among the most severely ill).
A comparison of the change in mean Clinical Global Impressions-Improvement (CGI-I) results from Visit 3 to end of treatment between active and placebo treatments.
The CGI-I is a clinician-rated scale that evaluates the improvement of psychopathology (ADHD symptoms in the study) on a scale from 1 (very much improved) to 7 (very much worse).

Full Information

First Posted
December 13, 2022
Last Updated
May 24, 2023
Sponsor
Corium, Inc.
Collaborators
Premier Research Group plc, Prometrika, LLC, Almac
search

1. Study Identification

Unique Protocol Identification Number
NCT05685732
Brief Title
An Efficacy and Safety Study w/ Azstarys® in Children With ADHD
Acronym
KP415P01
Official Title
A Multicenter, Dose-Optimized, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corium, Inc.
Collaborators
Premier Research Group plc, Prometrika, LLC, Almac

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate.
Detailed Description
Screening Period (Visit 1) Subjects will undergo a screening period up to 30 days prior to entering the Treatment Period. Double-Blind Treatment Period (Visit 2 through Visit 6) Eligible subjects will be randomized in a blinded fashion to Azstarys® or placebo at the start of the Treatment Period. Randomization will be applied separately in each cohort and stratified by gender. Cohort 1: Subjects 4 and 5 years (<6 years) will start at 13.1 mg/2.6 mg or matching placebo and may be titrated up or down to doses of 13.1 mg/2.6 mg, 26.1 mg/5.2 mg, or 39.2 mg/7.8 mg Azstarys® or matching placebo approximately each week through Visit 5 Cohort 2: Subjects 6-12 years (<13 years) will start at 39.2 mg/7.8 mg or matching placebo and may be titrated up or down to doses of 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg Azstarys® or matching placebo approximately each week through Visit 5

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The primary endpoint is defined as the change in a subject's ADHD Rating Scale total score in the Efficacy Population at Visit 6 compared to baseline (ADHD-RS total score at Visit 2). The Visit 2 baseline will be obtained prior to the first administration of study drug. The same analysis will be performed at other post-baseline visits. Visit 6 is the last visit of the Treatment Period (after the last dose of study drug).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study drug will be blinded during the Treatment Period. Neither the subject, the Investigator, nor the Sponsor will know the subject's treatment assignment.
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: SDX/d-MPH in 4-5 year old
Arm Type
Experimental
Arm Description
13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH
Arm Title
Cohort 1: Placebo in 4-5 year old
Arm Type
Placebo Comparator
Arm Description
matching placebo
Arm Title
Cohort 2: SDX/d-MPH in 6-12 year old
Arm Type
Experimental
Arm Description
26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH
Arm Title
Cohort 2: Placebo in 6-12 year old
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Intervention Description
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
A comparison of the change in mean ADHD Rating Scale (ADHD-RS) results from baseline to end of treatment between active and placebo treatments.
Description
The ADHD-RS is an 18-item scale based on Diagnostic and Statistical Manual of Mental Disorders criteria of ADHD that rates 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 scores range from 0 to 54. Scores will be obtained during a clinician-directed interview with the parent/guardian/caregiver at each visit.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
A comparison of the change in mean Clinical Global Impressions-Severity (CGI-S) results from baseline to end of treatment between active and placebo treatments.
Description
The CGI-S is a clinician-rated scale that evaluates the severity of psychopathology (ADHD symptoms in the study) on a scale from 1 (not at all ill) to 7 (among the most severely ill).
Time Frame
4 weeks
Title
A comparison of the change in mean Clinical Global Impressions-Improvement (CGI-I) results from Visit 3 to end of treatment between active and placebo treatments.
Description
The CGI-I is a clinician-rated scale that evaluates the improvement of psychopathology (ADHD symptoms in the study) on a scale from 1 (very much improved) to 7 (very much worse).
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In Cohort 1, subjects must be at least 4 years old and less than 5 years and 10 months at Screening; in Cohort 2, subjects must be at least 6 years old and less than 12 years and 10 months at Screening. Subjects must have a body weight within the 5th and 95th percentile according to the gender-specific weight-for-age percentile charts from the Centers for Disease Control and Prevention (CDC). See calculator at https://www.infantchart.com/child/. Female subjects must agree, if they are of childbearing potential at Screening or when they become of childbearing potential during the study, to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 14 days after the last dose of study drug. Childbearing potential is defined as follows: Girls under the age of 12 who have not had their first period will be considered "not of child-bearing potential." Girls 12 years of age (including girls who will become 13 years during the study) will be considered "of child-bearing potential," even if they have not yet had their first period. Irrespective of age, girls who have had their first period, will be considered "of child-bearing potential." Subjects must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical examinations, vital signs, electrocardiograms (ECGs), medical history, and clinical laboratory values (chemistry, hematology, urinalysis) at Screening. If any of the chemistry or hematology tests are not within the laboratory's reference range, then the subject can be included only if the Investigator determines the deviations to be not clinically relevant. At least one parent/legal guardian of the subject must voluntarily give written permission for him/her to participate in the study. Subjects in Cohort 2 must give written or verbal assent prior to study participation. For verbal assent, the procedure will be documented and signed by a witness. A parent or guardian may not be the witness for a child's verbal assent document. 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 Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid). Subject has had ADHD symptoms present for at least 6 months prior to the Screening Visit. Subject must be able and willing to wash out current stimulant ADHD medications, including herbal medications, from 5 days prior to the start of the Treatment Period, and abstain from taking these to the end of Visit 6 or ET; and wash out non-stimulant ADHD medications from 14 days prior to the start of the Treatment Period, and abstain from taking these to the end of Visit 6. Subject must have a score of ≥4 (Moderately Ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale. For subjects requiring washout of ADHD medications, this criterion refers to a score following washout. Subjects must have age and sex adjusted ratings of ≥90th percentile Total Score on the ADHD-Rating Scale (ADHD-RS) rated over the past 6 months (for 4- and 5-year old children, use Preschool Version of ADHD-RS-IV; for 6-12 years old children, use ADHD-RS-5). Subject functions at an age-appropriate level intellectually, as determined by the Investigator. Subject must have a systolic and diastolic blood pressure below the 95th percentile for age and gender according to the 2017 AAP guidelines (Flynn 2017) based on the average of 3 measurements 2-5 minutes apart. 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. Subject, parent/legal guardian, and caregiver (if applicable) must be able to speak and understand English or Spanish and be able to communicate satisfactorily with the Investigator and study coordinator. Exclusion Criteria: If female, must not be pregnant or breastfeeding, and if of childbearing potential, must have a negative urine pregnancy test at the start of the Screening Period. In addition, a positive pregnancy test before the last dose of study drug will result in early termination from the study. Subject with any clinically significant chronic medical condition that, in the judgment of the Investigator, 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. Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment, and, in the opinion of the Investigator, the ODD is mild to moderate, and eligible subjects with ODD are appropriate and cooperative during Screening. Subject has generalized anxiety disorder or panic disorder that has been the primary focus of treatment at any time during the 12 months prior to Screening or that has required pharmacotherapy any time during the 6 months prior to Screening. Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, depression, vascular disorder, potential CNS-related disorders that might occur in childhood (e.g., Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury. Subject taking anticonvulsants for seizure control or antidepressants currently or within the past 2 years before Screening are not eligible for study participation. A past history of febrile seizure or drug-induced seizure is allowed. Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, ODD, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Subjects allowed to enroll with any of these DSM disorders will require written justification from the Investigator documenting why the conditions will not interfere with participation and to emphasize that ADHD is the primary indication. In the opinion of the Investigator, subject has clinically significant suicidal ideation/behavior, based on history of attempted suicide and the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment at Screening. Subject has any clinically significant unstable medical abnormality, chronic disease (including asthma or diabetes), or a history of a clinically significant abnormality of the cardiovascular (including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension), gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with absorption, distribution, metabolism, or excretion of study drug. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the medical monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during Screening. Subject has a history or presence of abnormal ECGs, which in the Investigator's opinion is clinically significant. Subject has a history of, or currently has, a malignancy. Subject has uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone (TSH) ≤0.8 x the lower limit of normal (LLN) or ≥1.25 x the upper limit of normal (ULN) for the reference laboratory at Screening. Subject has greater than trace proteinuria in the urinalysis at Screening. Subjects with greater than trace proteinuria in the urinalysis at Screening but with a urine protein to creatinine (UP/C) ratio <0.2 in a first morning void urine sample will not be excluded from enrollment. Subjects has a current or recent (past 12 months) history of drug abuse; or current or recent history of drug abuse in someone living in the subject's home, or are using or planning to use prohibited drugs during the trial as specified in the protocol. Subject has a positive urine drug screen at Screening. Subjects with a positive methylphenidate (MPH) urine drug screen may be allowed to continue in the study, provided that the Investigator determines that the positive test is a result of taking prescribed medications and subject is willing to wash out the current medication as required. Subject has participated in any other clinical study with an investigational drug/product within 30 days or at least 5 half-lives, whichever is longer, prior to Screening. Subject has taken ADHD medications from more than one class within 30 days prior to Screening. Subjects on a stable dose of one ADHD medication with occasional use of ADHD medications from another class are eligible at the discretion of the Investigator. Subjects with demonstrated lack of response or intolerability to adequate dose and duration of treatment with MPH products. Judgment of adequate dose and duration is at the discretion of the Investigator. Subject has a positive urine MPH screen by dipstick (e.g., NarcoCheck®) at Visit 2. Subject is planning to initiate psychotherapy during the study (subjects participating in psychotherapy beginning at least 4 weeks before study initiation are permitted to continue). Subject has a history of severe allergies or adverse drug reactions to more than one class of medications. Subject has a history of allergic reaction or a known or suspected sensitivity to MPH or any substance that is contained in the study drug. Subject, parent/legal guardian, and caregiver (if applicable, at the Investigator's discretion) has commitments during the study that would interfere with attending study visits. Subject or subject's family anticipates a move outside the geographic range of the investigative site during the study period, or plans extended travel inconsistent with the recommended visit interval during study duration. Subject has one or more siblings living in the same household who are enrolled in this or another clinical drug trial. Subject shows evidence of current physical, sexual, or emotional abuse. Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Tashjian
Phone
6172337474
Email
rtashjian@coriumintl.com
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Oh, MD
Phone
857-331-7950
Email
coh@coriumintl.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Childress, MD
Organizational Affiliation
Center for Psychiatry And Behavioral Medicine Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preferred Research Partners (PRP)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Kelley
Phone
501-553-9987
Email
akelley@preferredresearchpartners.com
First Name & Middle Initial & Last Name & Degree
Renea Henderson, MD
Facility Name
IMMUNOe International Research center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen Collins
Phone
303-771-9000
Email
mcollins@immunoe.com
First Name & Middle Initial & Last Name & Degree
Joe Williams, MD
Facility Name
Vertex Research Group inc
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin Wing
Phone
352-261-0901
Email
austin.wing@vtxresearch.com
First Name & Middle Initial & Last Name & Degree
Ayesha Lall, M.A
Facility Name
Clinical Neuroscience Solutions- Orlando
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Angel
Phone
904-281-5757
Email
sangel@cnshealthcare.com
First Name & Middle Initial & Last Name & Degree
Nandita Jones, MD
Facility Name
Accel Research Sites
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Figueroa
Phone
863-940-2087
Email
cfigueroa@accelclinical.com
First Name & Middle Initial & Last Name & Degree
Rosa Negron, MD
Facility Name
Accel Research Sites
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley McCaffrey
Phone
407-644-1165
Email
amccaffrey@accelclinical.com
First Name & Middle Initial & Last Name & Degree
Andrea Marraffino, Ph.D
Facility Name
South Florida Research Phase I-IV INC
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisbelle Revoredo
Phone
305-418-0847
Email
lrevoredo@southfloridatrials.com
First Name & Middle Initial & Last Name & Degree
Silvia S Duluc, MD
Facility Name
CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric McCaffrey
Phone
407-425-5100
Email
emccaffrey@cnshealthcare.com
First Name & Middle Initial & Last Name & Degree
Robert Molpus, MD
Facility Name
Sky Clinical Research Network Group P.C
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quinci Kennedy
Phone
470-317-3604
Email
quinci.kennedy@skycrng.com
First Name & Middle Initial & Last Name & Degree
Yvonne Smith, MD
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgan Hecker
Phone
404-537-1281
Email
Morgan.Hecker@iresearchatlanta.com
First Name & Middle Initial & Last Name & Degree
Kimball Johnson, MS
Facility Name
CenExel iResearch, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Clifton
Phone
912-722-0800
Email
jennifer.clifton@iresearchsavannah.com
First Name & Middle Initial & Last Name & Degree
Yael Elfassy, M.S
Facility Name
DelRicht Research- Touro Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesley A Saketkoo
Phone
504-336-2667
Email
lsaketk@tulane.edu
First Name & Middle Initial & Last Name & Degree
Caroline Campion, MD
Facility Name
St. Charles Psychiatric Associates & Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Wilson
Phone
636-946-8032
Email
drwilson2017@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gregory Mattingly, MD
Facility Name
Boeson research
City
Missoula
State/Province
Montana
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Marshall
Phone
406-763-8833
Email
heatherm@bluemoose.me
First Name & Middle Initial & Last Name & Degree
Merlin Fausett, Ph.D
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Boman
Phone
402-817-2235
Email
kboman@alivation.com
First Name & Middle Initial & Last Name & Degree
Walter Duffy, MD
Facility Name
Center for Psychiatry and Behavioral Medicine Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randi Lampert
Phone
702-838-0742
Email
randi.lampert@gmail.com
First Name & Middle Initial & Last Name & Degree
Ann C Childress, MD
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Missy Chapman
Phone
937-276-4311
Email
daytonclinical@aol.com
First Name & Middle Initial & Last Name & Degree
Martin Schear, MD
Facility Name
IPS Research Company, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Korstjens
Phone
405-235-8188
Email
mkorstjens@ipsresearch.com
First Name & Middle Initial & Last Name & Degree
Louise Thurman
Facility Name
Clinical Nueroscience Solution, Inc
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Codi
Phone
901-843-1045
Email
canthony@cnhealthcare.com
First Name & Middle Initial & Last Name & Degree
Valerie Arnold, MD
Facility Name
Houston Clinical Trials
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johnny Timmons
Phone
713-527-8993
Email
jtimmons@houstonclintrials.com
First Name & Middle Initial & Last Name & Degree
Alain Katic, MD
Facility Name
AIM Trials
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Prashar
Phone
972-267-1988
Email
sonia.prashar@aimtrials.com
First Name & Middle Initial & Last Name & Degree
Sejal Mehta, Ph.D
Facility Name
Flourish Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Cortez
Phone
210-949-0122
Email
ncortez@flourishresearch.com
First Name & Middle Initial & Last Name & Degree
Kerry D Jesus, MS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Efficacy and Safety Study w/ Azstarys® in Children With ADHD

We'll reach out to this number within 24 hrs