search
Back to results

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD (KP415P02)

Primary Purpose

Attention Deficit/Hyperactivity Disorder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
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 focused on measuring ADHD, Azstarys, Serdexmethylphenidate, Attention Deficit Hyperactvity Disorder

Eligibility Criteria

4 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: New Subjects must be at least 4 years old and less than 5 years and 10 months old 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). Subject 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, ECGs, medical history, and clinical laboratory values (chemistry, hematology and urinalysis) at Screening. At least one parent/legal guardian of the subject must voluntarily give written permission for the subject to participate in the study. 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 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 Dose Optimization Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or Early Termination (ET); and wash out non-stimulant ADHD medications from 14 days prior to the start of the Dose Optimization Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or ET. Subject must have a score of ≥4 (Moderately Ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale. Subject functions at an age-appropriate level intellectually, as determined by the Investigator. Subject must have age and sex adjusted ratings of ≥90th percentile Total Score on the ADHD-RS-IV (Preschool Version) rated over the past 6 months. 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'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's 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 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. 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, 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 currently or within the past 2 years before Screening are not eligible for study participation. 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. In the opinion of the Investigator, subject has clinically significant suicidal ideation/behavior, based on history of attempted suicide and the 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 drug absorption, distribution, metabolism, or excretion of study drug. 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 on the urinalysis at Screening. A current or recent (past 12 months) history of drug abuse in someone living in the subjects' home. Subject has a positive urine screen for drugs of abuse at Screening. If the urine test is positive for any of the analytes at Screening, the subject will be excluded from study participation, with the exception of the following: Depending on a subject's current ADHD medication at Screening, the urine screen may test positive for MPH for treatment of their ADHD. 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, except for participation in Study KP415.P01. 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. Subject has demonstrated lack of response or intolerability to adequate dose and duration of treatment with methylphenidate products. Subject is using or planning to use prohibited drugs during the trial as specified in the protocol. 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 methylphenidate 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 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 Sites - LakelandRecruiting
  • Accel Research Sites - MaitlandRecruiting
  • South Florida Research Phase I-IV INCRecruiting
  • CNS Healthcare - OrlandoRecruiting
  • iResearch AtlantaRecruiting
  • CenExel iResearch, LLCRecruiting
  • Sky Clinical Research Network Group P.C.Recruiting
  • 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
  • Clinical Neuroscience Solution, IncRecruiting
  • Houston Clinical TrialsRecruiting
  • AIM TrialsRecruiting
  • Flourish ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

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

Outcomes

Primary Outcome Measures

A determination of safety and tolerability of up to 12 months of treatment with Azstarys
Safety and tolerability will be assessed by the incidence of adverse events reported in the study

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
May 24, 2023
Sponsor
Corium, Inc.
Collaborators
Premier Research Group plc, Prometrika, LLC, Almac, Worldwide Clinical Trials
search

1. Study Identification

Unique Protocol Identification Number
NCT05721235
Brief Title
A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD
Acronym
KP415P02
Official Title
A Multicenter, Dose-Optimized, Open-Label, Safety/Tolerability and Pharmacokinetic Study With Azstarys® in Children 4 and 5 Years of Age With Attention-Deficit/Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

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

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
The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.
Detailed Description
• Screening Period: New subjects will undergo a Screening Period up to 30 days prior to entering the Dose Optimization Phase. • Dose Optimization Phase: During the 3-week Dose Optimization Phase, subjects will start at 13.1 mg/2.6 mg, and may be titrated to doses of 26.1 mg/5.2 mg or 39.2 mg/7.8 mg Azstarys® capsules based on individual tolerability and best dose-response in the opinion of the Investigator. • Treatment Phase: Eligible subjects will receive single daily doses of Azstarys® for approximately 360 ±20 days (approximately 12 months). The starting dose of Azstarys® in the Treatment Phase will be the same as the optimized dose of Azstarys® at the end of the Dose Optimization Phase, either 13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day. The daily dose may be changed at any time to any of the allowed dose levels (13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day) at the Investigator' discretion, based on individual tolerability and dose response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder
Keywords
ADHD, Azstarys, Serdexmethylphenidate, Attention Deficit Hyperactvity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
The primary objective is to determine the safety and tolerability for up to 12 months of treatment with Azstarys based on incidence of adverse events
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm Description
13.1 mg/2.6 mg SDX/d-MPH, 26.1/5.2 mg SDX/d-MPH, or 39.2 mg/7.8 mg SDX/d-MPH
Intervention Type
Drug
Intervention Name(s)
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Intervention Description
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Primary Outcome Measure Information:
Title
A determination of safety and tolerability of up to 12 months of treatment with Azstarys
Description
Safety and tolerability will be assessed by the incidence of adverse events reported in the study
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New Subjects must be at least 4 years old and less than 5 years and 10 months old 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). Subject 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, ECGs, medical history, and clinical laboratory values (chemistry, hematology and urinalysis) at Screening. At least one parent/legal guardian of the subject must voluntarily give written permission for the subject to participate in the study. 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 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 Dose Optimization Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or Early Termination (ET); and wash out non-stimulant ADHD medications from 14 days prior to the start of the Dose Optimization Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or ET. Subject must have a score of ≥4 (Moderately Ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale. Subject functions at an age-appropriate level intellectually, as determined by the Investigator. Subject must have age and sex adjusted ratings of ≥90th percentile Total Score on the ADHD-RS-IV (Preschool Version) rated over the past 6 months. 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'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's 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 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. 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, 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 currently or within the past 2 years before Screening are not eligible for study participation. 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. In the opinion of the Investigator, subject has clinically significant suicidal ideation/behavior, based on history of attempted suicide and the 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 drug absorption, distribution, metabolism, or excretion of study drug. 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 on the urinalysis at Screening. A current or recent (past 12 months) history of drug abuse in someone living in the subjects' home. Subject has a positive urine screen for drugs of abuse at Screening. If the urine test is positive for any of the analytes at Screening, the subject will be excluded from study participation, with the exception of the following: Depending on a subject's current ADHD medication at Screening, the urine screen may test positive for MPH for treatment of their ADHD. 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, except for participation in Study KP415.P01. 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. Subject has demonstrated lack of response or intolerability to adequate dose and duration of treatment with methylphenidate products. Subject is using or planning to use prohibited drugs during the trial as specified in the protocol. 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 methylphenidate 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 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
617-233-7474
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
Amber McGuire
Phone
501-553-9987
Email
ambermcguire4@gmail.com
First Name & Middle Initial & Last Name & Degree
Renea Henderson, M.D
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@immunoeresearch.com
First Name & Middle Initial & Last Name & Degree
Joe Williams, M.D
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, M.D
Facility Name
Accel Research Sites - Lakeland
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
James Powell
Phone
863-940-2087
Email
japowell@accelclinical.com
First Name & Middle Initial & Last Name & Degree
Rosa Negron, M.D
Facility Name
Accel Research Sites - Maitland
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
Leomaris Truijillo
Phone
407-644-1165
Email
LTrujillo@accelclinical.com
First Name & Middle Initial & Last Name & Degree
Andrea Marraffino, M.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
Belkis Delgado
Phone
305-418-0847
Email
bdelgado@southfloridatrials.com
First Name & Middle Initial & Last Name & Degree
Silvia S Duluc, M.D
Facility Name
CNS Healthcare - Orlando
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
Felipe Suplicy
Phone
407-425-5100
Email
fsuplicy@cnshealthcare.com
First Name & Middle Initial & Last Name & Degree
Robert Molpus, M.D
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
Mary Burns
Phone
404-537-1281
Email
m.burns@cenexel.com
First Name & Middle Initial & Last Name & Degree
Kimball Johnson, M.S
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
912-744-0800
Email
j.clifton@cenexel.com
First Name & Middle Initial & Last Name & Degree
Yael Elfassy, M.S
Facility Name
Sky Clinical Research Network Group P.C.
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonita Washington
Phone
470-317-3604
Email
tonita.washington@skycrng.com
First Name & Middle Initial & Last Name & Degree
Yvonne Smith, M.D
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 Saketkoo
Phone
504-336-2667
Email
lsaketkoo@delricht.com
First Name & Middle Initial & Last Name & Degree
Caroline Campion, M.D
Facility Name
St Charles Psychiatric Associates & Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Wilson
Phone
636-946-8032
Email
drwilson@midwestresearchgroup.com
First Name & Middle Initial & Last Name & Degree
Gregory Mattingly, M.D
Facility Name
Boeson Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Patrick
Phone
406-763-8833
Email
tara@pirahealth.com
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
Michelle Fedon
Phone
402-817-2235
Email
mfedon@alivation.com
First Name & Middle Initial & Last Name & Degree
Walter Duffy, M.D
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, M.D
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
Amy Hitchler
Phone
937-276-4311
Email
amyhitchlernp@yahoo.com
First Name & Middle Initial & Last Name & Degree
Martin Schear, M.D
Facility Name
Clinical Neuroscience 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
Codi Anthony
Phone
901-843-1045
Email
canthony@cnhealthcare.com
First Name & Middle Initial & Last Name & Degree
Valerie Arnold, M.D
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
Carmen Almaguer
Phone
972-325-1573
Email
carmen.almaguer@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
Parke Hedges
Phone
210-949-0122
Email
phedges@flourishresearch.com
First Name & Middle Initial & Last Name & Degree
Kerry D Jesus, M.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD

We'll reach out to this number within 24 hrs