Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia



Status:Completed
Conditions:Insomnia Sleep Studies, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:6 - 17
Updated:10/28/2017
Start Date:May 2009
End Date:October 2011

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

A Long Term, Open-Label, Safety Study of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia

A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age,
inclusive) and adolescents (12 17 years of age, inclusive) with attention
deficit/hyperactivity disorder (ADHD) associated insomnia.

This is a multi center, open label, long term safety study in pediatric subjects 6 through 17
years of age, inclusive, with a diagnosis of ADHD associated insomnia. Subjects who complete
Study 190 246 (Rollover subjects) and meet the study enrollment criteria will be allowed to
participate in this long term safety study. Additionally, Treatment naïve subjects will be
enrolled in this long term safety study in order to meet the overall subject enrollment
objective of obtaining 100 subjects with 12 months of treatment. This study was previously
posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo
Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals
Inc.

Inclusion Criteria:

Inclusion Criteria:

- Subject is male or female 6 17 years of age, inclusive, at the time of consent.

- Subject must have a diagnosis of ADHD as defined by DSM-IV criteria • The diagnosis
for Rollover subjects will be taken from the Screening visit of Study 190 246.
Treatment naïve subjects will have these assessments performed at the Screening visit.

- Subject must have documented ADHD associated insomnia, defined as the subject or
subject's parent/legal guardian having reported repeated difficulty with sleep
initiation (sleep latency >30 minutes) or consolidation (wake time after sleep onset >
45 minutes),>despite adequate age appropriate time and opportunity for sleep.

- Subject has either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake
time after sleep onset (WASO) demonstrated by PSG.

- Subject or subject's parent/legal guardian should have reported daytime functional
impairment as a result of sleep problems.

- Subject or subject's parent/legal guardian should have reported attempted and failed
behavioral interventions for sleep problems, including a regular bedtime and rise
time.

- Subject's sleep disturbance must not be attributable to either the direct physiologic
effect of a drug of abuse or misuse of a prescribed medication whether it is being
used as intended or in an illicit manner.

- Female subjects ≥8 years of age must have a negative serum pregnancy test at screening

- Subject must be in good general health.

- Subject must be able to swallow tablets.

- If subjects are currently taking medication for ADHD, they must be on a stable dose
and regimen for at least one month, and preferably for at least 3 months prior to the
time of consent

Exclusion Criteria:

- Subject with weight <10th percentile for age and gender

- Subject has any clinically significant or unstable medical abnormality/illness

- Subject has a documented history of Bipolar I or II Disorder, major depression,
conduct disorder, generalized anxiety disorder (other than obsessive-compulsive
disorder) or any history of psychosis, as determined by medical or psychiatric history
or as determined by clinical interview using the MINI-Kid at Visit 1.

- Subject has periodic limb movement >5 times per hour, as demonstrated on PSG.

- Subject has sleep disordered breathing, as demonstrated on PSG.

- Subject has another primary sleep disorder (or secondary sleep disorder that is
causing clinical impairment or any other known or suspected medical or psychiatric
condition that has affected or may affect sleep

- Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones
more than once during the study.

- Subject has organic brain disease, or a history of febrile seizures.

- Subject is, in the opinion of the investigator, at suicidal or homicidal risk.

- Female subject who is pregnant, lactating or planning to become pregnant.

- Subject is taking any psychotropic or disallowed medications,

- Subject has a history of severe allergies to more than 1 class of medications or
multiple adverse drug reactions.

- Subject has a history of allergic reaction or has a known or suspected sensitivity to
racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.

- Subject has a history of alcohol or substance abuse within 3 months of study
participation

- Subject has participated in any investigational study within 30 days prior to study
entry or is currently participating in another clinical trial, except Study 190 246.
We found this trial at
88
sites
Orange City, Florida 32763
1128
mi
from
Orange City, FL
Click here to add this to my saved trials
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
1313
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
2417 Marshall Ave.
Imperial, California 92251
760-355-0176
1055
mi
from
Imperial, CA
Click here to add this to my saved trials
3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
1110
mi
from
Richmond, VA
Click here to add this to my saved trials
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
1420
mi
from
Warwick, RI
Click here to add this to my saved trials
Arlington, Texas 76011
348
mi
from
Arlington, TX
Click here to add this to my saved trials
Atlanta, Georgia 30342
798
mi
from
Atlanta, GA
Click here to add this to my saved trials
Beachwood, Ohio 44122
903
mi
from
Beachwood, OH
Click here to add this to my saved trials
Bloomfield Hills, Michigan 48302
835
mi
from
Bloomfield Hills, MI
Click here to add this to my saved trials
902
mi
from
Canton, OH
Click here to add this to my saved trials
Carson, California 90746
1173
mi
from
Carson, CA
Click here to add this to my saved trials
1123
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Colorado Springs, Colorado 80918
384
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Costa Mesa, California 92280
969
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Dallas, Texas 75243
339
mi
from
Dallas, TX
Click here to add this to my saved trials
DeSoto, Texas 75115
360
mi
from
DeSoto, TX
Click here to add this to my saved trials
Eagle, Idaho 83616
1051
mi
from
Eagle, ID
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
596
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
Enid, Oklahoma 73703
93
mi
from
Enid, OK
Click here to add this to my saved trials
Flowood, Mississippi 39232
563
mi
from
Flowood, MS
Click here to add this to my saved trials
Gainesville, Florida 32607
1046
mi
from
Gainesville, FL
Click here to add this to my saved trials
Glendale, California 91204
1167
mi
from
Glendale, CA
Click here to add this to my saved trials
Gresham, Oregon 97030
1372
mi
from
Gresham, OR
Click here to add this to my saved trials
Haverhill, Massachusetts 01830
1445
mi
from
Haverhill, MA
Click here to add this to my saved trials
Henderson, Nevada 89015
953
mi
from
Henderson, NV
Click here to add this to my saved trials
Hialeah, Florida 33013
1313
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77008
566
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77081
571
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46260
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
Click here to add this to my saved trials
Kirkland, Washington 98033
1405
mi
from
Kirkland, WA
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
583
mi
from
Lake Charles, LA
Click here to add this to my saved trials
967
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderhill, Florida 33319
1301
mi
from
Lauderhill, FL
Click here to add this to my saved trials
Libertyville, Illinois 60048
608
mi
from
Libertyville, IL
Click here to add this to my saved trials
8550 Cuthills Circle
Lincoln, Nebraska 68510
217
mi
from
Lincoln, NE
Click here to add this to my saved trials
222
mi
from
Lincoln, NE
Click here to add this to my saved trials
Little Rock, Arkansas 72205
369
mi
from
Little Rock, AR
Click here to add this to my saved trials
Louisville, Kentucky 40207
663
mi
from
Louisville, KY
Click here to add this to my saved trials
12959 Palms West Drive
Loxahatchee Groves, Florida 33470
1276
mi
from
Loxahatchee Groves, FL
Click here to add this to my saved trials
Maitland, Florida 32751
1138
mi
from
Maitland, FL
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
888
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
888
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
Naperville, Illinois 60563
583
mi
from
Naperville, IL
Click here to add this to my saved trials
New Albany, Indiana 47150
653
mi
from
New Albany, IN
Click here to add this to my saved trials
New Orleans, Louisiana 70114
700
mi
from
New Orleans, LA
Click here to add this to my saved trials
Newton, Massachusetts 02459
1436
mi
from
Newton, MA
Click here to add this to my saved trials
421 Merrimack Street
North Andover, Massachusetts 01845
1442
mi
from
North Andover, MA
Click here to add this to my saved trials
North Miami, Florida 33161
1316
mi
from
North Miami, FL
Click here to add this to my saved trials
Oceanside, California 92056
1136
mi
from
Oceanside, CA
Click here to add this to my saved trials
3230 Waring Court
Oceanside, California 92056
1137
mi
from
Oceanside, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
157
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
154
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
154
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
153
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73139
164
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California 92868
1154
mi
from
Orange, CA
Click here to add this to my saved trials
Orange, California 92868
1154
mi
from
Orange, CA
Click here to add this to my saved trials
Orem, Utah 84058
764
mi
from
Orem, UT
Click here to add this to my saved trials
1147
mi
from
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66211
190
mi
from
Overland Park, KS
Click here to add this to my saved trials
Owensboro, Kentucky 42301
581
mi
from
Owensboro, KY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19139
1221
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pinellas Park, Florida 33782
1109
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Plano, Texas 75024
328
mi
from
Plano, TX
Click here to add this to my saved trials
1385
mi
from
Portland, OR
Click here to add this to my saved trials
Princeton, New Jersey 08540
1252
mi
from
Princeton, NJ
Click here to add this to my saved trials
Riverside, California 92506
1123
mi
from
Riverside, CA
Click here to add this to my saved trials
Roswell, Georgia 30076
797
mi
from
Roswell, GA
Click here to add this to my saved trials
1389
mi
from
Salem, OR
Click here to add this to my saved trials
San Antonio, Texas 78258
561
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
1139
mi
from
San Diego, CA
Click here to add this to my saved trials
10655 Roselle Street
San Diego, California 92128
1141
mi
from
San Diego, CA
Click here to add this to my saved trials
1154
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Ana, California 92705
1152
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Ana, California 92705
1152
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Spring Hill, Florida 34609
1032
mi
from
Spring Hill, FL
Click here to add this to my saved trials
44344 Dequindre Road
Sterling Heights, Michigan 48314
845
mi
from
Sterling Heights, MI
Click here to add this to my saved trials
Tampa, Florida 33607
1114
mi
from
Tampa, FL
Click here to add this to my saved trials
Tucson, Arizona 85712
830
mi
from
Tucson, AZ
Click here to add this to my saved trials
4500 South Garnett Road
Tulsa, Oklahoma 74103
157
mi
from
Tulsa, OK
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
151
mi
from
Tulsa, OK
Click here to add this to my saved trials
Vernon Hills, Illinois 60061
605
mi
from
Vernon Hills, IL
Click here to add this to my saved trials
Virginia Beach, Virginia 23452
1193
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Wildomar, California 92595
1125
mi
from
Wildomar, CA
Click here to add this to my saved trials
Willingboro, New Jersey 08046
1239
mi
from
Willingboro, NJ
Click here to add this to my saved trials