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

Completed · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)

In brief

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.

Key facts

Study ID

NCT03260205

Run by

Shire

People needed

199

Starts

2017-09-06

Expected to finish

2018-10-23

Last updated by the study team

2021-06-08

Who can join

Age: 4 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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