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

NCT ID: NCT03260205

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-06
• Study Completion Date: 2018-10-23

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

SPD489 (Lisdexamfetamine dimesylate)

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.

Group Type: EXPERIMENTAL

SPD489 (Lisdexamfetamine dimesylate)

Intervention Type: DRUG

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

SPD489

Intervention Type: DRUG

SPD489

Interventions

Placebo

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

Intervention Type: DRUG

SPD489 (Lisdexamfetamine dimesylate)

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

SPD489

SPD489

Intervention Type: DRUG

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Harmonex, Inc

Dothan, Alabama, United States

Preferred Research Partners, Inc

Little Rock, Arkansas, United States

CMB Clinical Trials

Colton, California, United States

Sun Valley Research Center

Imperial, California, United States

Alliance for Wellness d/b/a Alliance for Research

Long Beach, California, United States

Asclepes Research

Panorama City, California, United States

Psychiatric Centers at San Diego

San Diego, California, United States

UCSF Dept of Psychiatry

San Francisco, California, United States

Elite Clinical Trials, Inc

Wildomar, California, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

Clinical Neuroscience Solutions

Orlando, Florida, United States

APG Research, LLC

Orlando, Florida, United States

University of South Florida

St. Petersburg, Florida, United States

University of South Florida Department Of Psychiatry

Tampa, Florida, United States

iResearch Atlanta LLC

Decatur, Georgia, United States

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Clinical Neurophysiology Services

Sterling Heights, Michigan, United States

Washington University

St Louis, Missouri, United States

Premier Psychiatric Reseach Institute, LLC

Lincoln, Nebraska, United States

Jersey Shore University Medical Center (JSUMC)

Neptune City, New Jersey, United States

Manhattan Behavioral Medicine

New York, New York, United States

University of Rochester

Rochester, New York, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Pediatric Associates of Fairfield, Inc

Fairfield, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, United States

Paradigm Research Professionals

Oklahoma City, Oklahoma, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Cyn3rgy Research Center

Gresham, Oregon, United States

Rainbow Research Inc

Barnwell, South Carolina, United States

Carolina Clinical Trials, Inc.

Charleston, South Carolina, United States

Coastal Carolina Research

Mt. Pleasant, South Carolina, United States

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, United States

BioBehavioral Research of Austin

Austin, Texas, United States

Bayou City Research Limited

Houston, Texas, United States

BI Research Center

Houston, Texas, United States

Red Oak Psychiatry Associates

Houston, Texas, United States

Road Runner Research

San Antonio, Texas, United States

Family Psychiatry of the Woodlands

The Woodlands, Texas, United States

Ericksen Research and Development

Clinton, Utah, United States

Clinical Research Partners, LLC

Petersburg, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Seattle Childrens Hospital, Pearl Clinic

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35577034 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SPD489-347

Identifier Type: -

Identifier Source: org_study_id