Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment



Status:Recruiting
Conditions:Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:12 - 17
Updated:3/6/2019
Start Date:July 31, 2018
End Date:December 20, 2019
Contact:Ronald Marcus, MD
Email:rmarcus@supernus.com
Phone:301-838-2569

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

Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

The purpose of this study is to evaluate the effect of SPN-810 for the treatment of impulsive
aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard
ADHD treatment.

This study is an addition to the ongoing pediatric studies (CHIME 1 and CHIME 2) to assess
the efficacy and safety of SPN-810 in the improvement of impulsive aggression (IA) behaviors
in adolescents with ADHD.

SPN-810 will be administered in patients diagnosed with ADHD and associated feature of IA,
who are currently being treated with an FDA-approved standard ADHD treatment and with
persistent IA behaviors. The frequency of impulsive aggressive behaviors will be assessed as
a primary outcome.

Inclusion Criteria:

- Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at
the time of screening) with a primary diagnosis of ADHD and currently taking an
optimized FDA-approved ADHD medication.

- IA will be confirmed at screening using R-MOAS scale and Vitiello Aggression
Questionnaire.

Exclusion Criteria:

- History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder,
schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome
or dissociative disorder, autism spectrum disorder, pervasive developmental disorder,
obsessive compulsive disorder, post-traumatic stress disorder, or intermittent
explosive disorder.

- Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive
compulsive disorder, post-traumatic stress disorder or intermittent explosive
disorder.

- Known or suspected intelligence quotient (IQ) <70, active suicidal plan/intent or
active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.
We found this trial at
38
sites
8550 Cuthills Circle
Lincoln, Nebraska 68526
Phone: 402-817-2235
217
mi
from
Lincoln, NE
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
570
mi
from
San Antonio, TX
Click here to add this to my saved trials
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Phone: 305-598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
1320
mi
from
South Miami, FL
Click here to add this to my saved trials
Arlington, Texas 76015
Phone: 817-538-9902
348
mi
from
Arlington, TX
Click here to add this to my saved trials
811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78759
Phone: 512-382-6661
507
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21205
Phone: 443-923-9326
1150
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beaumont, Texas 77702
Phone: 409-331-6040
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Berlin, New Jersey 08009
Phone: 856-756-7335
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clinton, Utah 84015
Phone: 801-614-5501
792
mi
from
Clinton, UT
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
Phone: 719-634-6576
386
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
1581 Dodd Drive
Columbus, Ohio 43210
Phone: 614-685-7373
810
mi
from
Columbus, OH
Click here to add this to my saved trials
Culver City, California 90230
Phone: 424-227-8127
1177
mi
from
Culver City, CA
Click here to add this to my saved trials
12655 North Central Expressway
Dallas, Texas 75243
Phone: 4697303282
338
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30030
Phone: 404-537-1281
805
mi
from
Decatur, GA
Click here to add this to my saved trials
DeSoto, Texas 75115
Phone: 972-283-6286
360
mi
from
DeSoto, TX
Click here to add this to my saved trials
Houston, Texas 77098
Phone: 713-527-8839
569
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77061
Phone: 832-532-4210
577
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
Phone: 904-281-5757
1061
mi
from
Jacksonville, FL
Click here to add this to my saved trials
3133 Lakeland Hills Boulevard
Lakeland, Florida 33805
Phone: 863-940-2087
1134
mi
from
Lakeland, FL
Click here to add this to my saved trials
Lampasas, Texas 76550
Phone: 512-556-4130
?
mi
from
Lampasas, TX
Click here to add this to my saved trials
Libertyville, Illinois 60048
Phone: 847-549-4214
608
mi
from
Libertyville, IL
Click here to add this to my saved trials
Maitland, Florida 32751
Phone: 407-644-1165
1138
mi
from
Maitland, FL
Click here to add this to my saved trials
Memphis, Tennessee 38119
Phone: 901-843-1045
479
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33155
Phone: 305-443-6496
1321
mi
from
Miami, FL
Click here to add this to my saved trials
Missouri City, Texas 77459
Phone: 832-532-4210
?
mi
from
Missouri City, TX
Click here to add this to my saved trials
Naperville, Illinois 60563
Phone: 630-983-2000
582
mi
from
Naperville, IL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
Phone: 405-753-4994
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
Phone: 405-286-2104
158
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California 92868
Phone: 714-289-1100
1154
mi
from
Orange, CA
Click here to add this to my saved trials
Orem, Utah 84058
Phone: 801-356-5555
764
mi
from
Orem, UT
Click here to add this to my saved trials
Overland Park, Kansas 66211
Phone: 913-438-8221
190
mi
from
Overland Park, KS
Click here to add this to my saved trials
Rochester, New York 14618
Phone: 585-241-9670
1124
mi
from
Rochester, NY
Click here to add this to my saved trials
Saint Charles, Missouri 63304
Phone: 636-946-8032
?
mi
from
Saint Charles, MO
Click here to add this to my saved trials
Tampa, Florida 33613
Phone: 813-974-2832
1110
mi
from
Tampa, FL
Click here to add this to my saved trials
The Woodlands, Texas 77381
Phone: 832-616-2674
541
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Washington, District of Columbia 20310
Phone: 202-476-3042
1128
mi
from
Washington,
Click here to add this to my saved trials