Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine



Status:Completed
Conditions:Cognitive Studies, Neurology, Neurology, Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:6 - 12
Updated:10/14/2017
Start Date:September 2012
End Date:October 2013

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

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine

This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled,
randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). The objective is to
evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo.

This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled,
randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) conducted at approximately
180 study centers. Patients who completed at least 12 weeks of study drug exposure during
lead-in study MEM-MD-91 and meet protocol specified responder criteria.

Inclusion Criteria:

1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91

2. Met responder criterion at two consecutive visits separated by at least two weeks in
lead-in study MEM-MD-91

3. Provide written informed assent, when developmentally appropriate, to participate in
the study before conduct of any study-specific procedures. The parent/guardian/LAR
must provide written informed consent before the patient's participation in the study.
A separate written informed consent for the caregiver must also be obtained before the
conduct of any study specific procedures

4. Have a knowledgeable caregiver who is capable of providing reliable information about
the patient's condition, attending all clinic visits with the patient, and overseeing
the administration of study drug. Every effort should be made to maintain the same
caregiver as used in the lead-in study throughout this study

5. Have normal results from the physical examination, laboratory tests, ECG, and vital
signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings
must be deemed not clinically significant by the Investigator and documented

6. Be able to speak and understand English sufficiently (or their native language if this
can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR
who is able to speak and understand English sufficiently (or their native language if
this can be accommodated by the site), to comprehend the nature of the study and to
allow for the completion of all study assessments

7. Have a family that is sufficiently organized and stable to guarantee adequate safety
monitoring and continuous attendance to clinic visits for the duration of the study

8. Females who are 9 years and older or who have had onset of menses must have a negative
urine pregnancy test at Visit 1

Exclusion Criteria:

1. Patients with a concurrent medical condition that might interfere with the conduct of
the study, confound interpretation of the study results, or endanger the patient's
well being

2. Significant risk of suicidality

3. Patients with evidence or history of malignancy (other than excised basal cell
carcinoma) or any significant hematologic, endocrine, cardiovascular (including any
rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease

4. Female patients of child-bearing potential who are not using or not willing to use a
conventional method of contraception approved by the PI. Abstinence is an acceptable
method of contraception

5. Patients requiring treatment with prohibited concomitant medications

6. Patients who, in the opinion of the Investigator, might not be suitable for the study

7. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its
affiliates or partners, or the study center
We found this trial at
82
sites
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Avon Lake, Ohio 44012
?
mi
from
Avon Lake, OH
Click here to add this to my saved trials
Bloomfield Hills, Michigan 48302
?
mi
from
Bloomfield Hills, MI
Click here to add this to my saved trials
Bothell, Washington 98011
?
mi
from
Bothell, WA
Click here to add this to my saved trials
Boulder, Colorado 80304
?
mi
from
Boulder, CO
Click here to add this to my saved trials
Bradenton, Florida 34208
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Bronx, New York 10467
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brussel,
Click here to add this to my saved trials
Cambridge, Massachusetts 02138
?
mi
from
Cambridge, MA
Click here to add this to my saved trials
Centennial, Colorado 80112
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Chapel Hill, North Carolina 27514
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, West Virginia 25304
?
mi
from
Charleston, WV
Click here to add this to my saved trials
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Destin, Florida 32541
?
mi
from
Destin, FL
Click here to add this to my saved trials
Dothan, Alabama 36305
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Evansville, Indiana 47712
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fargo, North Dakota 58103
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Fort Wayne, Indiana 46805
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Gainesville, Florida 32607
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Glendale, California 91205
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Gresham, Oregon 97030
?
mi
from
Gresham, OR
Click here to add this to my saved trials
Gulf Breeze, Florida 32561
?
mi
from
Gulf Breeze, FL
Click here to add this to my saved trials
Hartford, Connecticut 06106
?
mi
from
Hartford, CT
Click here to add this to my saved trials
Henderson, Nevada 89052
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77008
?
mi
from
Houston, TX
Click here to add this to my saved trials
Imperial, California 92251
?
mi
from
Imperial, CA
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Irvine, California 92618
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Johnstown, Pennsylvania 15904
?
mi
from
Johnstown, PA
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lexington, Massachusetts 02421
?
mi
from
Lexington, MA
Click here to add this to my saved trials
Libertyville, Illinois 60048
?
mi
from
Libertyville, IL
Click here to add this to my saved trials
Lincoln, Nebraska 68510
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90057
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40213
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
McMurray, Pennsylvania 15317
?
mi
from
McMurray, PA
Click here to add this to my saved trials
Media, Pennsylvania 19063
?
mi
from
Media, PA
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33133
?
mi
from
Miami, FL
Click here to add this to my saved trials
Middleton, Wisconsin 53562
?
mi
from
Middleton, WI
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Naperville, Illinois 60563
?
mi
from
Naperville, IL
Click here to add this to my saved trials
Nashville, Tennessee 37212
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Neptune, New Jersey 07753
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
New Orleans, Louisiana 70115
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
Newton, Massachusetts 02459
?
mi
from
Newton, MA
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oakland Park, Florida 33334
?
mi
from
Oakland Park, FL
Click here to add this to my saved trials
Ogden, Utah 84405
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange City, Florida 32763
?
mi
from
Orange City, FL
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Owensboro, Kentucky 42303
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Phoenix, Arizona 85006
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
Roanoke, Virginia 24104
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Salt Lake City, Utah 84124
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Ana, California 92701
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Seattle, Washington 98104
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sioux Falls, South Dakota 57108
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Springfield, Massachusetts 01199
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
The Woodlands, Texas 77381
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Tucson, Arizona 85741
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74135
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials
Wellington, Florida 33414
?
mi
from
Wellington, FL
Click here to add this to my saved trials
Wichita, Kansas 67206
?
mi
from
Wichita, KS
Click here to add this to my saved trials