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

Use our guide to learn which trials are right for you!

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
Dothan, Alabama 36303
616
mi
from 43215
Dothan, AL
Click here to add this to my saved trials
Anaheim, California 92805
Principal Investigator: Patrick Walsh
Phone: 714-493-7258
1960
mi
from 43215
Anaheim, CA
Click here to add this to my saved trials
2150 Peachford Road
Atlanta, Georgia 30338
423
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
Bardstown, Kentucky 40004
Principal Investigator: Daniela J Finn
Phone: 502-349-1569
198
mi
from 43215
Bardstown, KY
Click here to add this to my saved trials
Bellevue, Washington 98007
1998
mi
from 43215
Bellevue, WA
Click here to add this to my saved trials
Bloomfield Hills, Michigan 48302
Principal Investigator: Richard Jackson
Phone: 248-290-5400
181
mi
from 43215
Bloomfield Hills, MI
Click here to add this to my saved trials
2805 Hamilton Mill Road
Buford, Georgia 30519
Principal Investigator: Alexander Osowa
Phone: 678-541-0588
409
mi
from 43215
Buford, GA
Click here to add this to my saved trials
2051 Charlie Hall Boulevard
Charleston, South Carolina 29414
Principal Investigator: Robert Clifford
Phone: 843-518-5642
520
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
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...
275
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
Dayton, Ohio 45414
Principal Investigator: Julie S Shepard
Phone: 937-236-5396
63
mi
from 43215
Dayton, OH
Click here to add this to my saved trials
Doral, Florida 33166
Principal Investigator: Amol Malankar
Phone: 305-994-7599
989
mi
from 43215
Doral, FL
Click here to add this to my saved trials
Durham, North Carolina 27707
Principal Investigator: Mark Chandler
Phone: 919-401-6212
354
mi
from 43215
Durham, NC
Click here to add this to my saved trials
El Campo, Texas 77347
Principal Investigator: Nilesh Patel
Phone: 979-320-6173
1056
mi
from 43215
El Campo, TX
Click here to add this to my saved trials
Evansville, Indiana 47715
Principal Investigator: J. Christopher Sartore
Phone: 812-604-0088
276
mi
from 43215
Evansville, IN
Click here to add this to my saved trials
4160 West 16th Avenue
Hialeah, Florida 33012
Principal Investigator: Maria A. Carballosa
Phone: 305-443-3480
987
mi
from 43215
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77098
Principal Investigator: Alain Katic
Phone: 713-527-8448
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
673
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
League City, Texas 77573
Principal Investigator: Kokab A. Saeed
Phone: 713-797-6000
993
mi
from 43215
League City, TX
Click here to add this to my saved trials
Little Rock, Arkansas 72211
317
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
Meridian, Idaho 83642
Principal Investigator: Mark A. Turner
Phone: 208-377-8653
1725
mi
from 43215
Meridian, ID
Click here to add this to my saved trials
2400 Northwest 54th Street
Miami, Florida 33142
Principal Investigator: Armando Acevedo
Phone: 786-212-4187
990
mi
from 43215
Miami, FL
Click here to add this to my saved trials
550 West 84th Street
Miami, Florida 33175
Principal Investigator: Maria I Delgado
Phone: 786-703-5941
984
mi
from 43215
Miami, FL
Click here to add this to my saved trials
1952 Long Grove Drive
Mount Pleasant, South Carolina 29464
Principal Investigator: Stephen Stripling, MD
Phone: 843-518-5642
524
mi
from 43215
Mount Pleasant, SC
Click here to add this to my saved trials
1560 Wall Street
Naperville, Illinois 60563
Principal Investigator: Sandeep Gaonkar, MD
Phone: 630-416-8289
298
mi
from 43215
Naperville, IL
Click here to add this to my saved trials
Nashville, Tennessee 37203
Principal Investigator: James A Fry
Phone: 615-320-5340
333
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
5430 Jimmy Carter Boulevard
Norcross, Georgia 30093
Principal Investigator: Hoyt Gazaway
Phone: 678-585-4917
423
mi
from 43215
Norcross, GA
Click here to add this to my saved trials
North Miami, Florida 33161
Principal Investigator: Scott Segal
Phone: 305-722-8444
985
mi
from 43215
North Miami, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32801
Principal Investigator: Ahmed Elfaki
Phone: 407-269-0322
795
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32806
Principal Investigator: Robert Bond Molpus
Phone: +1 (904) 281-5757
796
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66211
Principal Investigator: William Murphy
Phone: 913-438-8221
623
mi
from 43215
Overland Park, KS
Click here to add this to my saved trials
Owensboro, Kentucky 42301
Principal Investigator: Carroll E. Howard
Phone: 270-685-4589
270
mi
from 43215
Owensboro, KY
Click here to add this to my saved trials
269 Medical Park Boulevard
Petersburg, Virginia 23805
360
mi
from 43215
Petersburg, VA
Click here to add this to my saved trials
Richland, Washington 99352
Principal Investigator: Lucien Thomas Megna
Phone: 509-628-2331
1862
mi
from 43215
Richland, WA
Click here to add this to my saved trials
7117 Brockton Avenue
Riverside, California 92506
Principal Investigator: Michael T Saito
Phone: 240-238-4917
1930
mi
from 43215
Riverside, CA
Click here to add this to my saved trials
Rockville, Maryland 20852
Principal Investigator: Naveena Hemanth
318
mi
from 43215
Rockville, MD
Click here to add this to my saved trials
550 Deep Valley Drive
Rolling Hills, California 90274
Principal Investigator: Lawrence D Sher
Phone: 310-265-1623
1986
mi
from 43215
Rolling Hills, CA
Click here to add this to my saved trials
4801 Weldon Spring Parkway
Saint Charles, Missouri 63301
Principal Investigator: Gregory Mattingly
Phone: 636-946-8032
417
mi
from 43215
Saint Charles, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
1138
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
Smyrna, Georgia 30080
Principal Investigator: Ashraf Attalla
Phone: 770-319-8025
428
mi
from 43215
Smyrna, GA
Click here to add this to my saved trials
Wadsworth, Ohio 44281
Principal Investigator: Matthew P. Finneran
Phone: 330-334-6229
99
mi
from 43215
Wadsworth, OH
Click here to add this to my saved trials