Autism Clinical Trial
Official title:
An Open-Label Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.
Status | Completed |
Enrollment | 906 |
Est. completion date | August 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: 1. Male or female outpatients. 2. Age of 6-12. 3. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) 4. 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 Exclusion Criteria: 1. Have enrolled in Study MEM-MD-57A 2. Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being. 3. Participation in any other clinical investigation using an experimental drug within 30 days of screening. 4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS. 5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Forest Investigative Site 177 | Camperdown | New South Wales |
Belgium | Forest Investigative Site 204 | Brussel | |
Belgium | Forest Investigative Site 203 | Bruxelles | |
Belgium | Forest Investigative Site 202 | Hoboken | |
Belgium | Forest Investigative Site 201 | Leuven | |
Canada | Forest Investigative Site 155 | Toronto | Ontario |
Colombia | Forest Investigative Site 227 | Barranquilla | |
Colombia | Forest Investigative Site 228 | Bello | |
Colombia | Forest Investigative Site 226 | Bogota | |
Estonia | Forest Investigative Site 276 | Tallinn | |
France | Forest Investigative Site 329 | Bron | Rhone |
France | Forest Investigative Site 326 | Paris | |
Hungary | Forest Investigative Site 376 | Budapest | |
Hungary | Forest Investigative Site 378 | Budapest | |
Hungary | Forest Investigative Site 379 | Budapest | |
Hungary | Forest Investigative Site 381 | Budapest | |
Hungary | Forest Investigative Site 382 | Gyula | |
Hungary | Forest Investigative Site 380 | Szeged | |
Iceland | Forest Investigative Site 401 | Kopavogur | |
Italy | Forest Investigative Site 453 | Roma | |
Italy | Forest Investigative Site 452 | Siena | |
Korea, Republic of | Forest Investigative Site 701 | Seoul | |
Korea, Republic of | Forest Investigative Site 702 | Seoul | |
Korea, Republic of | Forest Investigative Site 703 | Seoul | |
Korea, Republic of | Forest Investigative Site 704 | Yangsan-si | Gyeongsangnam-do |
New Zealand | Forest Investigative Site 526 | Wellington | |
Poland | Forest Investigative Site 578 | Gdansk | |
Poland | Forest Investigative Site 579 | Gdansk | |
Poland | Forest Investigative Site 580 | Kielce | |
Poland | Forest Investigative Site 576 | Kobierzyce | |
Poland | Forest Investigative Site 577 | Warszawa | |
Serbia | Forest Investigative Site 626 | Belgrade | |
Serbia | Forest Investigative Site 627 | Belgrade | |
Serbia | Forest Investigative Site 629 | Nis | |
Serbia | Forest Investigative Site 628 | Novi Sad | |
Singapore | Forest Investigative Site 651 | Singapore | |
South Africa | Forest Investigative Site 676 | Cape Town | Western Cape |
Spain | Forest Investigative Site 729 | Barcelona | |
Spain | Forest Investigative Site 727 | Madrid | |
Spain | Forest Investigative Site 728 | Sabadell | Barcelona |
Spain | Forest Investigative Site 730 | Torremolinos | Málaga |
Ukraine | Forest Investigative Site 803 | Donetsk | |
Ukraine | Forest Investigative Site 807 | Kharkiv | |
Ukraine | Forest Investigative Site 802 | Kherson | Vil. Stepanivka |
Ukraine | Forest Investigative Site 804 | Kyiv | |
Ukraine | Forest Investigative Site 801 | Odesa | |
United States | Forest Investigative Site 081 | Albuquerque | New Mexico |
United States | Forest Investigative Site 107 | Albuquerque | New Mexico |
United States | Forest Investigative Site 069 | Avon Lake | Ohio |
United States | Forest Investigative Site 071 | Bothell | Washington |
United States | Forest Investigative Site 078 | Boulder | Colorado |
United States | Forest Investigative Site 075 | Bradenton | Florida |
United States | Forest Investigative Site 098 | Bronx | New York |
United States | Forest Investigative Site 073 | Centennial | Colorado |
United States | Forest Investigative Site 072 | Chapel Hill | North Carolina |
United States | Forest Investigative Site 105 | Charleston | South Carolina |
United States | Forest Investigative Site 119 | Charleston | West Virginia |
United States | Forest Investigative Site 064 | Charlottesville | Virginia |
United States | Forest Investigative Site 028 | Clinton | Utah |
United States | Forest Investigative Site 001 | Columbus | Ohio |
United States | Forest Investigative Site 068 | Dothan | Alabama |
United States | Forest Investigative Site 082 | Evansville | Indiana |
United States | Forest Investigative Site 123 | Fort Wayne | Indiana |
United States | Forest Investigative Site 080 | Gainesville | Florida |
United States | Forest Investigative Site 054 | Glendale | California |
United States | Forest Investigative Site 053 | Gresham | Oregon |
United States | Forest Investigative Site 130 | Henderson | Nevada |
United States | Forest Investigative Site 051 | Houston | Texas |
United States | Forest Investigative Site 109 | Imperial | California |
United States | Forest Investigative Site 056 | Indianapolis | Indiana |
United States | Forest Investigative Site 084 | Indianapolis | Indiana |
United States | Forest Investigative Site 066 | Irvine | California |
United States | Forest Investigative Site 117 | Jacksonville | Florida |
United States | Forest Investigative Site 132 | Johnstown | Pennsylvania |
United States | Forest Investigative Site 095 | Lake Charles | Louisiana |
United States | Forest Investigative Site 104 | Las Vegas | Nevada |
United States | Forest Investigative Site 102 | Libertyville | Illinois |
United States | Forest Investigative Site 097 | Lincoln | Nebraska |
United States | Forest Investigative Site 116 | Lincoln | Nebraska |
United States | Forest Investigative Site 077 | Little Rock | Arkansas |
United States | Forest Investigative Site 096 | Los Angeles | California |
United States | Forest Investigative Site 061 | Louisville | Kentucky |
United States | Forest Investigative Site 065 | Maitland | Florida |
United States | Forest Investigative Site 131 | McMurray | Pennsylvania |
United States | Forest Investigative Site 100 | Media | Pennsylvania |
United States | Forest Investigative Site 090 | Memphis | Tennessee |
United States | Forest Investigative Site 118 | Miami | Florida |
United States | Forest Investigative Site 063 | Middleton | Wisconsin |
United States | Forest Investigative Site 023 | Naperville | Illinois |
United States | Forest Investigative Site 057 | Nashville | Tennessee |
United States | Forest Investigative Site 136 | Neptune | New Jersey |
United States | Forest Investigative Site 091 | New Orleans | Louisiana |
United States | Forest Investigative Site 059 | Newton | Massachusetts |
United States | Forest Investigative Site 113 | Norfolk | Virginia |
United States | Forest Investigative Site 085 | Oakland Park | Florida |
United States | Forest Investigative Site 141 | Ogden | Utah |
United States | Forest Investigative Site 019 | Oklahoma City | Oklahoma |
United States | Forest Investigative Site 115 | Orange City | Florida |
United States | Forest Investigative Site 062 | Orlando | Florida |
United States | Forest Investigative Site 114 | Orlando | Florida |
United States | Forest Investigative Site 124 | Orlando | Florida |
United States | Forest Investigative Site 125 | Orlando | Florida |
United States | Forest Investigative Site 074 | Owensboro | Kentucky |
United States | Forest Investigative Site 005 | Phoenix | Arizona |
United States | Forest Investigative Site 086 | Rockville | Maryland |
United States | Forest Investigative Site 029 | Salt Lake City | Utah |
United States | Forest Investigative Site 021 | San Francisco | California |
United States | Forest Investigative Site 026 | Santa Ana | California |
United States | Forest Investigative Site 108 | Springfield | Massachusetts |
United States | Forest Investigative Site 002 | Stanford | California |
United States | Forest Investigative Site 067 | Tampa | Florida |
United States | Forest Investigative Site 070 | The Woodlands | Texas |
United States | Forest Investigative Site 127 | Toms River | New Jersey |
United States | Forest Investigative Site 055 | Tucson | Arizona |
United States | Forest Investigative Site 092 | Tulsa | Oklahoma |
United States | Forest Investigative Site 052 | Washington | District of Columbia |
United States | Forest Investigative Site 101 | Wellington | Florida |
United States | Forest Investigative Site 106 | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States, Australia, Belgium, Canada, Colombia, Estonia, France, Hungary, Iceland, Italy, Korea, Republic of, New Zealand, Poland, Serbia, Singapore, South Africa, Spain, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Confirmed Social Responsiveness Scale (SRS) Responders | A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a = 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks. The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment. |
Visit 1 (Baseline) to Visit 8 (week 48/Final Visit) | No |
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