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Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Placebo

SPD489 (Lisdexamfetamine dimesylate)

SPD489

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring SPD489, Lisdexamfetamine dimesylate, ADHD, hyperactivity, Neurobehavioral disorder

Eligibility Criteria

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

Inclusion Criteria:

Participant is a male or female aged 4-5 years inclusive at the time of consent
Participant's parent(s) or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the participant before completing any study related procedures.
Participant and parent(s)/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing.
Participant must meet DSM-IV-TR criteria for a primary diagnosis of ADHD (any sub-type).
Participant has an ADHD-RS-IV Preschool Version Total Score at the baseline visit (Visit 0) greater than or equal to 28 for boys, and greater than or equal to 24 for girls.
Participant has a Clinical Global Impressions - Severity of Illness (CGI-S) score greater than or equal to 4 at the baseline visit (Visit 0).
Participant has a Peabody Picture Vocabulary Test standard score of greater than or equal to 70 at the screening visit (Visit -1).
Participant has undergone an adequate course of non-pharmacological treatment or has a severe enough condition to consider enrollment without undergoing prior non-pharmacological treatment.
Participant has participated in a structured group activity (e.g, preschool, sports, Sunday school) so as to assess symptoms and impairment in a setting outside the home.
Participant has lived with the same parent(s) or guardian for greater than or equal to 6 months.

Exclusion Criteria:

Participant is required to or anticipates the need to take any prohibited medications or medications that have central nervous system (CNS) effects or have an effect on performance. Stable use of bronchodilator inhalers is not exclusionary.
Participant has taken another investigational product or has taken part in a clinical study within 30 days prior to the screening visit (Visit -1).
Participant is well-controlled on his/her current ADHD medication with acceptable tolerability.
Participant has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments or may increase risk to the participant..
Participant has glaucoma.
Participant has failed to fully respond to an adequate course of amphetamine therapy.
Participant has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
Participant has a known family history of sudden cardiac death or ventricular arrhythmia.
Participant has a blood pressure measurement greater than or equal to 95th percentile for age, sex, and height at the screening visit (Visit -1) or the baseline visit (Visit 0) or history of moderate or severe hypertension.
Participant has a known history of symptomatic cardiovascular disease, unexplained syncope, exertional chest pain,advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
Participant has any clinically significant clinical laboratory abnormalities at the screening visit (Visit -1) or electrocardiogram (ECG) at screening visit (Visit-1) or baseline visit (Visit 0) based on investigator judgment.
Participant has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4) at the screening visit (Visit -1). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
Participant has a current, controlled (requiring medication or therapy) or uncontrolled, co-morbid psychiatric disorder including but not limited to any of the below co-morbid Axis I disorders and Axis II disorders:
i. post-traumatic stress disorder or adjustment disorder ii. bipolar illness, psychosis, or a family history of these disorders iii. pervasive developmental disorder iv. obsessive-compulsive disorder (OCD) v. psychosis/schizophrenia vi. a serious tic disorder, or a family history of Tourette's disorder vii. Participant is currently considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation.

viii. a history of physical, sexual, or emotional abuse ix. any other disorder or agitated state that in the opinion of the investigator, contraindicates SPD489 or lisdexamfetamine dimesylate treatment or confound efficacy or safety assessments.

Participant has initiated behavioral therapy within 1 month of the baseline visit (Visit 0). Participant may not initiate behavioral therapy during the study.
Participant has a height less than equal to (<=) 5th percentile for age and sex at the screening visit (Visit -1).
Participant has a weight <= 5th percentile for age and sex at the screening visit (Visit -1).
Participant lives with anyone who currently abuses stimulants or cocaine.
Participant has a history of seizures (other than infantile febrile seizures).
Participant is taking any medication that is excluded per the protocol.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

SPD489 (Lisdexamfetamine dimesylate)

Arm Description

Participant will receive placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.

Participants will be randomized to receive SPD489 capsule in a 5:5:5:5:6 ratio to SPD489 5, 10, 20, 30 milligram (mg) orally once daily for 6 weeks. Dosing will begin with the lowest strength of SPD489 (5 mg), and will be titrated until the randomly assigned fixed-dose is reached.

Outcomes

Primary Outcome Measures

Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6

ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.

Secondary Outcome Measures

Clinical Global Impressions Global Improvement (CGI-I) at Week 6

CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.

Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6

Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP.

Number of Participants With Potentially Clinically Significant Changes in Vital Signs

Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data.

Change From Baseline in Height at Week 6

Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.

Change From Baseline in Body Weight at Week 6

Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (<) 5th, 5th to < 95th, and greater than or equal to (>=) 95th percentiles. Change from baseline in body weight at Week 6 was reported.

Change From Baseline in Body Mass Index (BMI) at Week 6

BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI < 5th percentile); Healthy weight (BMI 5th percentile up to < 85th percentile); Overweight (BMI 85th percentile < 95th percentile); Obese (BMI >= 95th percentile). Change from baseline in body mass index at Week 6 was reported.

Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values

Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, > = represents greater than or equal to.

Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters

Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data.

Children's Sleep Habits Questionnaire (CSHQ) at Week 6

Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.

Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS)

C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported.

Full Information

NCT ID

NCT03260205

First Posted

August 9, 2017

Last Updated

May 16, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT03260205

Brief Title

Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

Official Title

A Phase 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-Dose Safety and Efficacy Study of SPD489 Compared With Placebo in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

September 6, 2017 (Actual)

Primary Completion Date

October 23, 2018 (Actual)

Study Completion Date

October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

SPD489, Lisdexamfetamine dimesylate, ADHD, hyperactivity, Neurobehavioral disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

199 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participant will receive placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.

Arm Title

SPD489 (Lisdexamfetamine dimesylate)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.

Intervention Type

Drug

Intervention Name(s)

SPD489 (Lisdexamfetamine dimesylate)

Intervention Description

SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.

Intervention Type

Drug

Intervention Name(s)

SPD489

Intervention Description

SPD489

Primary Outcome Measure Information:

Title

Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6

Description

Time Frame

Baseline, Week 6

Secondary Outcome Measure Information:

Title

Clinical Global Impressions Global Improvement (CGI-I) at Week 6

Description

Time Frame

Week 6

Title

Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6

Description

Time Frame

Baseline, Week 6

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

From start of study drug administration up to follow-up (Week 7)

Title

Number of Participants With Potentially Clinically Significant Changes in Vital Signs

Description

Time Frame

Week 6

Title

Change From Baseline in Height at Week 6

Description

Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.

Time Frame

Baseline, Week 6

Title

Change From Baseline in Body Weight at Week 6

Description

Time Frame

Baseline, Week 6

Title

Change From Baseline in Body Mass Index (BMI) at Week 6

Description

Time Frame

Baseline, Week 6

Title

Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values

Description

Time Frame

Week 6

Title

Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters

Description

Time Frame

Week 6

Title

Children's Sleep Habits Questionnaire (CSHQ) at Week 6

Description

Time Frame

Week 6

Title

Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS)

Description

Time Frame

Up to Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant is a male or female aged 4-5 years inclusive at the time of consent Participant's parent(s) or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the participant before completing any study related procedures. Participant and parent(s)/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing. Participant must meet DSM-IV-TR criteria for a primary diagnosis of ADHD (any sub-type). Participant has an ADHD-RS-IV Preschool Version Total Score at the baseline visit (Visit 0) greater than or equal to 28 for boys, and greater than or equal to 24 for girls. Participant has a Clinical Global Impressions - Severity of Illness (CGI-S) score greater than or equal to 4 at the baseline visit (Visit 0). Participant has a Peabody Picture Vocabulary Test standard score of greater than or equal to 70 at the screening visit (Visit -1). Participant has undergone an adequate course of non-pharmacological treatment or has a severe enough condition to consider enrollment without undergoing prior non-pharmacological treatment. Participant has participated in a structured group activity (e.g, preschool, sports, Sunday school) so as to assess symptoms and impairment in a setting outside the home. Participant has lived with the same parent(s) or guardian for greater than or equal to 6 months. Exclusion Criteria: Participant is required to or anticipates the need to take any prohibited medications or medications that have central nervous system (CNS) effects or have an effect on performance. Stable use of bronchodilator inhalers is not exclusionary. Participant has taken another investigational product or has taken part in a clinical study within 30 days prior to the screening visit (Visit -1). Participant is well-controlled on his/her current ADHD medication with acceptable tolerability. Participant has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments or may increase risk to the participant.. Participant has glaucoma. Participant has failed to fully respond to an adequate course of amphetamine therapy. Participant has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product. Participant has a known family history of sudden cardiac death or ventricular arrhythmia. Participant has a blood pressure measurement greater than or equal to 95th percentile for age, sex, and height at the screening visit (Visit -1) or the baseline visit (Visit 0) or history of moderate or severe hypertension. Participant has a known history of symptomatic cardiovascular disease, unexplained syncope, exertional chest pain,advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Participant has any clinically significant clinical laboratory abnormalities at the screening visit (Visit -1) or electrocardiogram (ECG) at screening visit (Visit-1) or baseline visit (Visit 0) based on investigator judgment. Participant has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4) at the screening visit (Visit -1). Treatment with a stable dose of thyroid medication for at least 3 months is permitted. Participant has a current, controlled (requiring medication or therapy) or uncontrolled, co-morbid psychiatric disorder including but not limited to any of the below co-morbid Axis I disorders and Axis II disorders: i. post-traumatic stress disorder or adjustment disorder ii. bipolar illness, psychosis, or a family history of these disorders iii. pervasive developmental disorder iv. obsessive-compulsive disorder (OCD) v. psychosis/schizophrenia vi. a serious tic disorder, or a family history of Tourette's disorder vii. Participant is currently considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. viii. a history of physical, sexual, or emotional abuse ix. any other disorder or agitated state that in the opinion of the investigator, contraindicates SPD489 or lisdexamfetamine dimesylate treatment or confound efficacy or safety assessments. Participant has initiated behavioral therapy within 1 month of the baseline visit (Visit 0). Participant may not initiate behavioral therapy during the study. Participant has a height less than equal to (<=) 5th percentile for age and sex at the screening visit (Visit -1). Participant has a weight <= 5th percentile for age and sex at the screening visit (Visit -1). Participant lives with anyone who currently abuses stimulants or cocaine. Participant has a history of seizures (other than infantile febrile seizures). Participant is taking any medication that is excluded per the protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Harmonex, Inc

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

Preferred Research Partners, Inc

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

CMB Clinical Trials

City

Colton

State/Province

California

ZIP/Postal Code

92324

Country

United States

Facility Name

Sun Valley Research Center

City

Imperial

State/Province

California

ZIP/Postal Code

92251

Country

United States

Facility Name

Alliance for Wellness d/b/a Alliance for Research

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Asclepes Research

City

Panorama City

State/Province

California

ZIP/Postal Code

91402

Country

United States

Facility Name

Psychiatric Centers at San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

UCSF Dept of Psychiatry

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Elite Clinical Trials, Inc

City

Wildomar

State/Province

California

ZIP/Postal Code

92595

Country

United States

Facility Name

Avail Clinical Research, LLC

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Sarkis Clinical Trials

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc.

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Medical Research Group of Central Florida

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

Clinical Neuroscience Solutions

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

APG Research, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

University of South Florida

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Name

University of South Florida Department Of Psychiatry

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

iResearch Atlanta LLC

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Lake Charles Clinical Trials

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70629

Country

United States

Facility Name

Kennedy Krieger Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Rochester Center for Behavioral Medicine

City

Rochester Hills

State/Province

Michigan

ZIP/Postal Code

48306

Country

United States

Facility Name

Clinical Neurophysiology Services

City

Sterling Heights

State/Province

Michigan

ZIP/Postal Code

48314

Country

United States

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Premier Psychiatric Reseach Institute, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68526

Country

United States

Facility Name

Jersey Shore University Medical Center (JSUMC)

City

Neptune

State/Province

New Jersey

ZIP/Postal Code

07753

Country

United States

Facility Name

Manhattan Behavioral Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10036

Country

United States

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

University Hospitals Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Pediatric Associates of Fairfield, Inc

City

Fairfield

State/Province

Ohio

ZIP/Postal Code

45014

Country

United States

Facility Name

IPS Research Company

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Oklahoma Clinical Research Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Paradigm Research Professionals

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73118

Country

United States

Facility Name

Cutting Edge Research Group

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Cyn3rgy Research Center

City

Gresham

State/Province

Oregon

ZIP/Postal Code

97030

Country

United States

Facility Name

Rainbow Research Inc

City

Barnwell

State/Province

South Carolina

ZIP/Postal Code

29812

Country

United States

Facility Name

Carolina Clinical Trials, Inc.

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Coastal Carolina Research

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

BioBehavioral Research of Austin

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Bayou City Research Limited

City

Houston

State/Province

Texas

ZIP/Postal Code

77007

Country

United States

Facility Name

BI Research Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

Red Oak Psychiatry Associates

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Road Runner Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78249

Country

United States

Facility Name

Family Psychiatry of the Woodlands

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77381

Country

United States

Facility Name

Ericksen Research and Development

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Facility Name

Clinical Research Partners, LLC

City

Petersburg

State/Province

Virginia

ZIP/Postal Code

23805

Country

United States

Facility Name

Northwest Clinical Research Center

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

Seattle Childrens Hospital, Pearl Clinic

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Citations:

PubMed Identifier

35577034

Citation

Childress AC, Lloyd E, Jacobsen L, Gunawardhana L, Johnson SA Jr, Findling RL. Efficacy and Safety of Lisdexamfetamine in Preschool Children With Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2022 Dec;61(12):1423-1434. doi: 10.1016/j.jaac.2022.03.034. Epub 2022 May 13.

Results Reference

derived

Learn more about this trial

Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

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Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder (ADHD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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