Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years



Status:Completed
Conditions:Neurology, Psychiatric, ADHD
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:6 - 12
Updated:6/21/2018
Start Date:November 17, 2017
End Date:June 7, 2018

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A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Fixed-Dose, Efficacy, and Safety Study of SHP465 in Children Aged 6-12 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the
treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.


Inclusion Criteria:

- Participant is male or female aged 6-12 years inclusive at the time of consent.

- Participant's parent or legally authorized representative (LAR) must provide signature
of informed consent, and there must be documentation of assent (as applicable) by the
participant.

- Participant must meet Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition (DSM-5) criteria for a primary diagnosis of ADHD (any subtype).

- Participant who is a female and of child-bearing potential must not be pregnant and
agree to comply with any applicable contraceptive requirements.

- Participant has an ADHD-RS-5 Child, Home Version Total Score of greater than or equal
to (>=) 28 and Clinical Global Impression - Severity of Illness (CGI-S) score >=4 at
baseline (Visit 2). Participant is currently not on ADHD therapy, or is not completely
satisfied with their current ADHD therapy.

Exclusion Criteria:

- Participant is required or anticipated to take medications that have central nervous
system effects or affect performance. Stable use of bronchodilator inhalers is not
exclusionary.

- Participant has a concurrent chronic or acute illness, disability, or other condition
that might confound the results of safety assessments conducted in the study or that
might increase risk to the participant.

- Participant has a documented allergy, hypersensitivity, or intolerance to amphetamine
or to any excipients in the investigational product.

- Participant has failed to fully respond, based on investigator judgment, to an
adequate course of amphetamine therapy.

- Participant has a known family history of sudden cardiac death or ventricular
arrhythmia.

- Participant has a blood pressure measurement >=95th percentile for age, sex, and
height at screening (Visit 1) and/or baseline (Visit 2).

- Participant has a height less than or equal to (<=) 5th percentile for age and sex at
screening (Visit 1) or baseline (Visit 2).

- Participant has a weight <=5th percentile for age and sex at screening (Visit 1) or
baseline (Visit 2).

- Participant has a known history of symptomatic cardiovascular disease, structural
cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, or other
serious cardiac conditions placing them at increased vulnerability to the
sympathomimetic effects of a stimulant drug.

- Participant has a history of seizures (other than infantile febrile seizures).

- Participant is taking any medication that is excluded per the protocol.

- Participant had any clinically significant ECG or clinical laboratory abnormalities at
the screening (Visit 1) or baseline visit (Visit 2).

- Participant has current abnormal thyroid function, defined as abnormal
thyroid-stimulating hormone and thyroxine at the screening or baseline visit.
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, comorbid psychiatric disorder.

- 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 currently
demonstrating suicidal ideation.
We found this trial at
41
sites
550 Deep Valley Drive
Rolling Hills, California 90274
Principal Investigator: Lawrence D Sher
Phone: 310-265-1623
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Anaheim, California 92805
Principal Investigator: Patrick Walsh
Phone: 714-493-7258
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2150 Peachford Road
Atlanta, Georgia 30338
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Bardstown, Kentucky 40004
Principal Investigator: Daniela J Finn
Phone: 502-349-1569
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Bellevue, Washington 98007
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Bloomfield Hills, Michigan 48302
Principal Investigator: Richard Jackson
Phone: 248-290-5400
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2805 Hamilton Mill Road
Buford, Georgia 30519
Principal Investigator: Alexander Osowa
Phone: 678-541-0588
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2051 Charlie Hall Boulevard
Charleston, South Carolina 29414
Principal Investigator: Robert Clifford
Phone: 843-518-5642
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Vishal Madaan
Phone: 434-243-6366
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Dayton, Ohio 45414
Principal Investigator: Julie S Shepard
Phone: 937-236-5396
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Doral, Florida 33166
Principal Investigator: Amol Malankar
Phone: 305-994-7599
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Dothan, Alabama 36303
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Durham, North Carolina 27707
Principal Investigator: Mark Chandler
Phone: 919-401-6212
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El Campo, Texas 77347
Principal Investigator: Nilesh Patel
Phone: 979-320-6173
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Evansville, Indiana 47715
Principal Investigator: J. Christopher Sartore
Phone: 812-604-0088
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4160 West 16th Avenue
Hialeah, Florida 33012
Principal Investigator: Maria A. Carballosa
Phone: 305-443-3480
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Houston, Texas 77098
Principal Investigator: Alain Katic
Phone: 713-527-8448
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Jacksonville, Florida 32216
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League City, Texas 77573
Principal Investigator: Kokab A. Saeed
Phone: 713-797-6000
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Little Rock, Arkansas 72211
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Meridian, Idaho 83642
Principal Investigator: Mark A. Turner
Phone: 208-377-8653
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2400 Northwest 54th Street
Miami, Florida 33142
Principal Investigator: Armando Acevedo
Phone: 786-212-4187
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550 West 84th Street
Miami, Florida 33175
Principal Investigator: Maria I Delgado
Phone: 786-703-5941
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1952 Long Grove Drive
Mount Pleasant, South Carolina 29464
Principal Investigator: Stephen Stripling, MD
Phone: 843-518-5642
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1560 Wall Street
Naperville, Illinois 60563
Principal Investigator: Sandeep Gaonkar, MD
Phone: 630-416-8289
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Nashville, Tennessee 37203
Principal Investigator: James A Fry
Phone: 615-320-5340
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5430 Jimmy Carter Boulevard
Norcross, Georgia 30093
Principal Investigator: Hoyt Gazaway
Phone: 678-585-4917
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North Miami, Florida 33161
Principal Investigator: Scott Segal
Phone: 305-722-8444
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Oklahoma City, Oklahoma 73103
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Orlando, Florida 32801
Principal Investigator: Ahmed Elfaki
Phone: 407-269-0322
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Orlando, Florida 32806
Principal Investigator: Robert Bond Molpus
Phone: +1 (904) 281-5757
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Overland Park, Kansas 66211
Principal Investigator: William Murphy
Phone: 913-438-8221
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Owensboro, Kentucky 42301
Principal Investigator: Carroll E. Howard
Phone: 270-685-4589
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269 Medical Park Boulevard
Petersburg, Virginia 23805
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Richland, Washington 99352
Principal Investigator: Lucien Thomas Megna
Phone: 509-628-2331
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7117 Brockton Avenue
Riverside, California 92506
Principal Investigator: Michael T Saito
Phone: 240-238-4917
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Rockville, Maryland 20852
Principal Investigator: Naveena Hemanth
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4801 Weldon Spring Parkway
Saint Charles, Missouri 63301
Principal Investigator: Gregory Mattingly
Phone: 636-946-8032
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San Antonio, Texas 78229
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Smyrna, Georgia 30080
Principal Investigator: Ashraf Attalla
Phone: 770-319-8025
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Wadsworth, Ohio 44281
Principal Investigator: Matthew P. Finneran
Phone: 330-334-6229
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