Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
This study is enrolling participants by invitation only.
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01592773
First received: May 3, 2012
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
| Condition | Intervention | Phase |
|---|---|---|
|
Autism Spectrum Disorder (ASD) Autism Autistic Disorder Asperger's Disorder Asperger's Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Pervasive Child Development Disorder |
Drug: Memantine Hydrochloride (HCl) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Extension 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
Asperger syndrome
MedlinePlus related topics:
Asperger Syndrome
Autism
Child Development
Developmental Disabilities
Infant and Newborn Development
Toddler Development
U.S. FDA Resources
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Safety [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]Adverse event (AE) recording, clinical laboratory measures, vital signs parameters, electrocardiograms (ECGs), cognitive testing, suicidality, and physical examinations
| Estimated Enrollment: | 220 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Memantine
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 will begin this study with 6 weeks of double blind dosing during which all patients will either be titrated to or remain on their maximum target dosages. Patients who have had a break of > 3days since last treatment will be titrated. This will be followed by 42 weeks of open-label dosing. Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM MD 91, will receive 48 weeks of open-label memantine at their maximum tolerated weight based target dosage. |
Drug: Memantine Hydrochloride (HCl)
During double-blind treatment Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing will be once daily. During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage will be that identified during the prior studies for each patient. Dosing will be once daily. Other Name: Namenda
|
Detailed Description:
This clinical study will be a 48-week, multicenter, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at approximately 180 study centers. Patients may be eligible for this long-term extension study if they have:
- completed the open-label Study MEM MD 67,
- completed the open-label Study MEM-MD-91,
- completed the double-blind study MEM-MD-68,
- discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who completed Study MEM-MD-67, MEM-MD-68 or MEM-MD-91.
- Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
Exclusion Criteria:
- Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592773
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| United States, Alabama | |
| Forest Investigative Site 068 | |
| Dothan, Alabama, United States, 36303 | |
| United States, Arizona | |
| Forest Investigative Site 005 | |
| Phoenix, Arizona, United States, 85006 | |
| Forest Investigative Site 055 | |
| Tucson, Arizona, United States, 85718 | |
| United States, Arkansas | |
| Forest Investigative Site 077 | |
| Little Rock, Arkansas, United States, 72202-3591 | |
| United States, California | |
| Forest Investigative Site 054 | |
| Glendale, California, United States, 91206 | |
| Forest Investigative Site 109 | |
| Imperial, California, United States, 92251 | |
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| Irvine, California, United States, 92612 | |
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| Los Angeles, California, United States, 90024 | |
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| San Francisco, California, United States, 94143-0984 | |
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| Santa Ana, California, United States, 92701 | |
| Forest Investigative Site 103 | |
| Santa Ana, California, United States, 92705 | |
| Forest Investigative Site 002 | |
| Stanford, California, United States, 94305-5719 | |
| United States, Colorado | |
| Forest Investigative Site 078 | |
| Boulder, Colorado, United States, 80304 | |
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| Centennial, Colorado, United States, 80112 | |
| United States, Connecticut | |
| Forest Investigative Site 111 | |
| Hartford, Connecticut, United States, 06106 | |
| United States, District of Columbia | |
| Forest Investigative Site 052 | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| Forest Investigative Site 075 | |
| Bradenton, Florida, United States, 32751 | |
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| Destin, Florida, United States, 32541 | |
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| Gainesville, Florida, United States, 32607 | |
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| Gulf Breeze, Florida, United States, 32561 | |
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| Hialeah, Florida, United States, 33012 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Maitland, Florida, United States, 32751 | |
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| Miami, Florida, United States, 33155 | |
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| Oakland Park, Florida, United States, 33334 | |
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| Orange City, Florida, United States, 32763 | |
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| Orlando, Florida, United States, 32806 | |
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| Orlando, Florida, United States, 32803 | |
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| Orlando, Florida, United States, 32839 | |
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| Tampa, Florida, United States, 33613 | |
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| Wellington, Florida, United States, 33414 | |
| United States, Illinois | |
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| Libertyville, Illinois, United States, 60048 | |
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| Naperville, Illinois, United States, 60563 | |
| United States, Indiana | |
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| Evansville, Indiana, United States, 47713 | |
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| Fort Wayne, Indiana, United States, 46805 | |
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| Indianapolis, Indiana, United States, 46202 | |
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| Indianapolis, Indiana, United States, 46260 | |
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| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| Forest Investigative Site 106 | |
| Wichita, Kansas, United States, 67214-3199 | |
| United States, Kentucky | |
| Forest Investigative Site 061 | |
| Louisville, Kentucky, United States, 40202 | |
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| Owensboro, Kentucky, United States, 42301 | |
| United States, Louisiana | |
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| Lake Charles, Louisiana, United States, 70605 | |
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| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Forest Investigative Site 086 | |
| Rockville, Maryland, United States, 20852 | |
| United States, Massachusetts | |
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| Cambridge, Massachusetts, United States, 02138 | |
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| Lexington, Massachusetts, United States, 02421 | |
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| Newton, Massachusetts, United States, 02459 | |
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| Springfield, Massachusetts, United States, 01199 | |
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| Bloomfield Hills, Michigan, United States, 48302 | |
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| Lincoln, Nebraska, United States, 68526 | |
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| Lincoln, Nebraska, United States, 68516 | |
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| Henderson, Nevada, United States, 89052 | |
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| Las Vegas, Nevada, United States, 89128 | |
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| Neptune, New Jersey, United States, 07753 | |
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| Toms River, New Jersey, United States, 08755 | |
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| Albuquerque, New Mexico, United States, 87108-5129 | |
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| Albuquerque, New Mexico, United States, 87109 | |
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| Bronx, New York, United States, 10467 | |
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| New York, New York, United States, 10032 | |
| United States, North Carolina | |
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| Chapel Hill, North Carolina, United States, 27514 | |
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| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
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| Avon Lake, Ohio, United States, 44012 | |
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| Cleveland, Ohio, United States, 44109 | |
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| Cleveland, Ohio, United States, 44106 | |
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| Cleveland, Ohio, United States, 44106 | |
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| Columbus, Ohio, United States, 43210 | |
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| Oklahoma City, Oklahoma, United States, 73116 | |
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| Tulsa, Oklahoma, United States, 74104 | |
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| Gresham, Oregon, United States, 97030 | |
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| Portland, Oregon, United States, 97239 | |
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| Johnstown, Pennsylvania, United States, 15904 | |
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| McMurray, Pennsylvania, United States, 15317 | |
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| Media, Pennsylvania, United States, 19063 | |
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| Charleston, South Carolina, United States, 29407 | |
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| Sioux Falls, South Dakota, United States, 57105 | |
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| Memphis, Tennessee, United States, 38119 | |
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| Nashville, Tennessee, United States, 37232 | |
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| Houston, Texas, United States, 77054 | |
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| Houston, Texas, United States, 77090 | |
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| The Woodlands, Texas, United States, 77381 | |
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| Clinton, Utah, United States, 84015 | |
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| Salt Lake City, Utah, United States, 84106 | |
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| Charlottesville, Virginia, United States, 22903 | |
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| Norfolk, Virginia, United States, 23507 | |
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| Roanoke, Virginia, United States, 24014 | |
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| Bothell, Washington, United States, 98011 | |
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| Seattle, Washington, United States, 98121 | |
| United States, West Virginia | |
| Forest Investigative Site 119 | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| Forest Investigative Site 063 | |
| Middleton, Wisconsin, United States, 53562 | |
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| Milwaukee, Wisconsin, United States, 53201 | |
| Belgium | |
| Forest Investigative Site 204 | |
| Brussels, Belgium, 1020 | |
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| Hoboken, Belgium, 2660 | |
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| Jette, Belgium, 1090 | |
| Canada, Ontario | |
| Forest Investigative Site 152 | |
| Toronto, Ontario, Canada, M4G 1R8 | |
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| Toronto, Ontario, Canada, M4S 1Y2 | |
| Canada, Quebec | |
| Forest Investigative Site 151 | |
| Montreal, Quebec, Canada, H1Y3L1 | |
| Colombia | |
| Forest Investigative Site 228 | |
| Antioquia, Bello, Colombia | |
| Forest Investigative Site 226 | |
| Bogota, Colombia | |
| Estonia | |
| Forest Investigative Site 276 | |
| Tallinn, Estonia, 10617 | |
| Hungary | |
| Forest Investigative Site 378 | |
| Budapest, Hungary, 1089 | |
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| Budapest, Hungary, 1083 | |
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| Budapest, Hungary, 1026 | |
| Iceland | |
| Forest Investigative Site 401 | |
| Kopavogur, Iceland, 200 | |
| Italy | |
| Forest Investigative Site 453 | |
| Roma, Italy, 00165 | |
| Forest Investigative Site 452 | |
| Siena, Italy, 53100 | |
| Korea, Republic of | |
| Forest Investigative Site 701 | |
| Seoul, Korea, Republic of, 138736 | |
| Forest Investigative Site 703 | |
| Seoul, Korea, Republic of, 120752 | |
| New Zealand | |
| Forest Investigative Site 526 | |
| Wellington, New Zealand, 7902 | |
| Poland | |
| Forest Investigative Site 579 | |
| Gdansk, Poland, 80542 | |
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| Gdansk, Poland, 80952 | |
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| Kielce, Poland, 25317 | |
| Forest Investigative Site 576 | |
| Tyniec Maly, Poland, 55040 | |
| Forest Investigative Site 577 | |
| Warsaw, Poland, 80214 | |
| Serbia | |
| Forest Investigative Site 627 | |
| Belgrade, Serbia, 11000 | |
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| Belgrade, Serbia, 11000 | |
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| Nis, Serbia, 18000 | |
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| Novi Sad, Serbia, 21000 | |
| South Africa | |
| Forest Investigative Site 676 | |
| Bellville Cape Town, South Africa, 7530 | |
| Spain | |
| Forest Investigative Site 729 | |
| Barcelona, Spain, 08221 | |
| Forest Investigative Site 728 | |
| Sabadell, Spain, 08208 | |
| Forest Investigative Site 730 | |
| Torremolinos, Spain, 29620 | |
| Ukraine | |
| Forest Investigative Site 802 | |
| Kherson, Ukraine, 73488 | |
| Forest Investigative Site 801 | |
| Odessa, Ukraine, 65014 | |
Sponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | Jordan Lateiner, MS, MBA | Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc. |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01592773 History of Changes |
| Other Study ID Numbers: | MEM-MD-69 |
| Study First Received: | May 3, 2012 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Public Health Agency of Canada Estonia: The State Agency of Medicine Italy: Ethics Committee New Zealand: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Forest Laboratories:
|
Autistic Disorder Asperger's Disorder Asperger's |
Pediatric Autism Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Pervasive Child Development Disorder |
Additional relevant MeSH terms:
|
Autistic Disorder Developmental Disabilities Child Development Disorders, Pervasive Asperger Syndrome Mental Disorders Diagnosed in Childhood Mental Disorders Memantine Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013