Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.
Study Start Date
Estimated Completion Date
- Drug: SHP465
- Drug: Placebo
- Pediatrics: Child/Adolescent Psych
- Psychiatry: Child/Adolescent Psych,Neuro/Psych Pharmacol,Neuropsych Sciences
- Neurology: Neuro/Psych pharmacology,Neuropsych Sciences
- Pharmacy: Neuro/Psych pharmacology
- Attention Deficit Disorder with Hyperactivity
- Mental Disorders
Shire -- SHP465-305
1. Subject must be 6-17 years of age, inclusive, at the time of consent.
2. Subject's parent or legally authorized representative (LAR) must provide signature of
informed consent, and there must be documentation of assent (if applicable) by the
subject indicating that the subject is aware of the investigational nature of the
study and the required procedures and restrictions in accordance with the ICH GCP
Guideline E6 (1996) and applicable regulations before completing any study-related
3. Subject and parent/LAR are willing and able to comply with all of the testing and
requirements defined in the protocol, including oversight of morning dosing.
Specifically, the parent/LAR must be available at approximately 7:00AM (±2 hours) to
dispense the dose of investigational product for the study duration.
4. Subject, who is a female and of child-bearing potential, must not have a positive
serum beta human chorionic gonadotropin pregnancy test at the Screening Visit (Visit
1) and must have a negative urine pregnancy test at the Baseline Visit (Visit 2) and
agree to comply with any applicable contraceptive requirements of the protocol.
5. Subject must have a satisfactory medical assessment with no clinically significant or
6. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed
7. Subject has an ADHD-RS-IV Total Score >28 at the Baseline Visit (Visit 2).
8. Subject is functioning at an age-appropriate level intellectually, as determined by
the study Investigator.
9. Subject is currently not on ADHD therapy, or is not completely satisfied with any
aspect of their current ADHD therapy.
10. Subject is able to swallow a capsule whole.
1. Subject has a current, controlled (with medications prohibited in this study) or
uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any
significant comorbid Axis II disorder or significant Axis I disorder (such as
post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental
disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or
other symptomatic manifestations that, in the opinion of the examining clinician,
will contraindicate treatment with SHP465 or confound efficacy or safety assessments.
Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit 1)
interview of the K-SADS-PL and additional modules if warranted by the results of the
initial interview. Subjects may continue participation in a behavioral modification
program during the study as long as they have been participating in the program for
at least 1 month at the time of the Baseline Visit (Visit 2).
2. Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorder
is not exclusionary.
3. Subject is considered a suicide risk in the opinion of the Investigator, has
previously made a suicide attempt, or is currently demonstrating active suicidal
ideation. Subjects with intermittent passive suicidal ideation are not necessarily
excluded based on the assessment of the Investigator.
4. Subject is underweight based on Centers for Disease Control and Prevention body mass
index (BMI)-for-age sex-specific values at the Screening Visit (Visit 1). Underweight
is defined as a BMI <3rd percentile
5. Subject is significantly overweight based on Centers for Disease Control and
Prevention BMI-for-age sex specific values at the Screening Visit (Visit 1).
Significantly overweight is defined as a BMI >97th percentile for this study
6. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis
or an infectious process requiring antibiotics), disability, or other condition that
might confound the results of safety assessments conducted in the study or that might
increase risk to the subject. Similarly, the subject will be excluded if he or she
has any additional condition(s) that, in the Investigator's opinion, would prohibit
the subject from completing the study or would not be in the best interest of the
subject. The additional conditions would include any significant illness or unstable
medical condition that could lead to difficulty complying with the protocol. Mild,
stable asthma is not exclusionary.
7. Subject has a history of seizure (other than infantile febrile seizures), a chronic
or current tic disorder, or a current diagnosis of Tourette's Disorder. Subject has a
history of tics that are judged by the Investigator to be exclusionary.
8. Subject's blood pressure measurements exceed the 90th percentile for age, sex, and
height (based on the Blood Pressure Levels by Age and Height Percentile [for boys and
girls]) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2)
9. Subject has a known history of hypertension
10. Subject has a known history of symptomatic cardiovascular disease, advanced
arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart
rhythm abnormalities, coronary artery disease, or other serious cardiac problems that
may place him/her at increased vulnerability to the sympathomimetic effects of a
11. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
12. Subject has any clinically significant ECG or clinically significant laboratory
abnormality at the Screening Visit (Visit 1).
13. Subject has current abnormal thyroid function, defined as abnormal thyroid
stimulating hormone and thyroxine at the Screening Visit (Visit 1). Treatment with a
stable dose of thyroid medication for at least 3 months is permitted.
14. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or
to any excipients in the investigational product.
15. Subject has failed to respond, based on Investigator judgment, to an adequate
course(s) (dose and duration) of amphetamine therapy
16. Subject has a history of suspected substance abuse or dependence disorder (excluding
nicotine) in accordance with DSM-IV-TR criteria. Subjects with a lifetime history of
amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
17. Subject has a positive urine drug result at the Screening Visit (Visit 1) (with the
exception of subject's current stimulant therapy, if any) or the Baseline Visit
(Visit 2), if repeated unless the Investigator can verify that the positive result at
the Screening Visit (Visit 1) is attributed to medication that has been prescribed to
the subject and will be discontinued prior to the Baseline Visit (Visit 2). A
positive result at the Screening Visit (Visit 1) attributed to a prescribed
medication requires a re-test and a negative result at the Baseline Visit (Visit 2)
to confirm subject eligibility.
18. Subject has taken another investigational product or has taken part in a clinical
study within 30 days prior to the Screening Visit (Visit 1).
19. Subject has previously completed, discontinued, or was withdrawn from this study.
20. Subject is taking any medication that is excluded or has not been appropriately
washed out according to the protocol requirements.
21. Subject is required to take or anticipates the need to take medications that have
central nervous system effects or affect performance, such as sedating antihistamines
and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of
bronchodilator inhalers is not exclusionary.
22. Subject is female and is pregnant or lactating
6 Years to 17 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (36)
|Omega Medical Research - Warwick, Rhode Island||49.1 miles||None||None||None|
|Rochester Center For Behavioral Medicine - Rochester Hills, Michigan||613.5 miles||None||None||None|
|Midwest Clinical Research Center - Dayton, Ohio||708.9 miles||None||None||None|
|Coastal Carolina Research Center - Mt. Pleasant, South Carolina||815.9 miles||None||None||None|
|Rainbow Research - Barnwell, South Carolina||843.9 miles||None||None||None|
|Capstone Clinical Research - Libertyville, Illinois||861.5 miles||None||None||None|
|Baber Research Group Inc - Naperville, Illinois||876.6 miles||None||None||None|
|Northwest Behavioral Research Center - Marietta, Georgia||933.9 miles||None||None||None|
|Clinical Neuroscience Solutions Inc - Jacksonville, Florida||1,021.9 miles||None||None||None|
|Psychiatric Care and Research Center - O'fallon, Missouri||1,045.1 miles||None||None||None|
|Midwest Research Group - St. Charles, Missouri||1,055.2 miles||None||None||None|
|Sarkis Clinical Trials - Gainesville, Florida||1,083.3 miles||None||None||None|
|Medical Research Group of Central Florida - Orange City, Florida||1,090.5 miles||None||None||None|
|Harmonex Neuroscience Research - Dothan, Alabama||1,102.1 miles||None||None||None|
|Clinical Neuroscience Solutions Inc - Orlando, Florida||1,117.3 miles||None||None||None|
|Clinical Neuroscience Solution Inc - Memphis, Tennessee||1,128.4 miles||None||None||None|
|Janus Center For Psychiatric Research - West Palm Beach, Florida||1,194.5 miles||None||None||None|
|Florida Clinical Research Center Llc - Bradenton, Florida||1,219.8 miles||None||None||None|
|Psychiatric Associates - Overland Park, Kansas||1,255.4 miles||None||None||None|
|Miami Research Associates Llc - South Miami, Florida||1,267.3 miles||None||None||None|
|Louisiana Research Associates Inc - New Orleans, Louisiana||1,359.4 miles||None||None||None|
|Tulsa Clinical Research Llc - Tulsa, Oklahoma||1,394.9 miles||None||None||None|
|Research Across America - Plano, Texas||1,541.8 miles||None||None||None|
|Futuresearch Trials of Dallas Lp - Dallas, Texas||1,545.0 miles||None||None||None|
|Red Oak Psychiatry Associates Pa - Houston, Texas||1,598.9 miles||None||None||None|
|Bayou City Research - Houston, Texas||1,607.2 miles||None||None||None|
|Houston Clinical Trials Llc - Houston, Texas||1,609.5 miles||None||None||None|
|McB Clinical Research Centers - Colorado Springs, Colorado||1,776.6 miles||None||None||None|
|Westex Clinical Investigations - Lubbock, Texas||1,777.9 miles||None||None||None|
|Center For Psychiatry and Behavioral Medicine - Las Vegas, Nevada||2,380.5 miles||None||None||None|
|Eastside Therapeutic Resource - Kirkland, Washington||2,482.2 miles||None||None||None|
|Elite Clinical Trials Inc - Wildomar, California||2,559.4 miles||None||None||None|
|Oregon Center For Clinical Investigations Inc - Salem, Oregon||2,561.0 miles||None||None||None|
|Encompass Clinical Research - Spring Valley, California||2,572.2 miles||None||None||None|
|Pcsd Feighner Research - San Diego, California||2,580.0 miles||None||None||None|
|Nrc Research Institute - Orange, California||2,585.0 miles||None||None||None|