Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT02466425

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-18
• Study Completion Date: 2016-02-16

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

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

Study Groups

SHP465

Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours)

Group Type: EXPERIMENTAL

SHP465

Intervention Type: DRUG

12.5mg and 25mg capsules (one capsule daily)

Placebo

Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo capsule that appear identical in size, weight, shape, color

Interventions

SHP465

12.5mg and 25mg capsules (one capsule daily)

Intervention Type: DRUG

Placebo

Matching placebo capsule that appear identical in size, weight, shape, color

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 procedures.

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 relevant abnormalities.

6. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.

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.

Exclusion Criteria

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 stimulant medication.

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 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 Neuroscience Research

Dothan, Alabama, United States

Nrc Research Institute

Orange, California, United States

Pcsd Feighner Research

San Diego, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Elite Clinical Trials, Inc

Wildomar, California, United States

McB Clinical Research Centers

Colorado Springs, Colorado, United States

Florida Clinical Research Center, Llc

Bradenton, 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, Inc.

Orlando, Florida, United States

Miami Research Associates, Llc

South Miami, Florida, United States

Janus Center For Psychiatric Research

West Palm Beach, Florida, United States

Northwest Behavioral Research Center

Marietta, Georgia, United States

Capstone Clinical Research

Libertyville, Illinois, United States

Baber Research Group Inc

Naperville, Illinois, United States

Psychiatric Associates

Overland Park, Kansas, United States

Louisiana Research Associates, Inc

New Orleans, Louisiana, United States

Rochester Center For Behavioral Medicine

Rochester Hills, Michigan, United States

Psychiatric Care and Research Center

O'Fallon, Missouri, United States

Midwest Research Group

Saint Charles, Missouri, United States

Center For Psychiatry and Behavioral Medicine

Las Vegas, Nevada, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Tulsa Clinical Research, Llc

Tulsa, Oklahoma, United States

Oregon Center For Clinical Investigations, Inc

Salem, Oregon, United States

Omega Medical Research

Warwick, Rhode Island, United States

Rainbow Research

Barnwell, South Carolina, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Clinical Neuroscience Solution, Inc

Memphis, Tennessee, United States

Futuresearch Trials of Dallas, Lp

Dallas, Texas, United States

Bayou City Research

Houston, Texas, United States

Red Oak Psychiatry Associates, Pa

Houston, Texas, United States

Houston Clinical Trials, Llc

Houston, Texas, United States

Westex Clinical Investigations

Lubbock, Texas, United States

Research Across America

Plano, Texas, United States

Eastside Therapeutic Resource

Kirkland, Washington, United States

Countries

United States

References

Brams M, Childress AC, Greenbaum M, Yu M, Yan B, Jaffee M, Robertson B. SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results of a Randomized, Double-Blind Placebo-Controlled Study. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):19-28. doi: 10.1089/cap.2017.0053. Epub 2017 Aug 17.

Reference Type: RESULT

PMID: 28816509 (View on PubMed)

Other Identifiers

SHP465-305

Identifier Type: -

Identifier Source: org_study_id