An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
This study is currently recruiting participants.
Verified April 2013 by Forest Laboratories
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01592786
First received: May 3, 2012
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
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 eligible patients for participation in the follow-up randomized withdrawal study.
| 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 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: 50 weeks ] [ Designated as safety issue: Yes ]Adverse event (AE) monitoring, clinical laboratory measures, vital sign parameters, electrocardiograms (ECGs), suicidality, and physical examinations.
| Estimated Enrollment: | 850 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Memantine Hydrochloride (HCl)
This 50-week multicenter clinical study is comprised of a 2-week screening period, a 6-week open label dose-titration period followed up by a 42-week open-label maintenance period.
|
Drug: Memantine Hydrochloride (HCl)
Up to 50 weeks, multicenter, open-label study, Memantine extended-release 3-mg capsules, oral administration. Dosing will be weight based.
Other Name: Namenda
|
Detailed Description:
This 50-week multicenter clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by up to 42-week open-label maintenance period.
Approximately 192 pediatric patients (aged 6-12 years) may enter this study at approximately 180 study centers. Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion will be eligible to transition to a randomized withdrawal study.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female outpatients.
- Age of 6-12.
- 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)
- 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:
- Have enrolled in Study MEM-MD-57A
- Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being.
- Participation in any other clinical investigation using an experimental drug within 30 days of screening.
- Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592786
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Contacts
| Contact: Sandra Beaird, Pharm.D | 1-800-678-1605 ext 66297 | FRXClinTrials@frx.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Forest Investigative Site 068 | Recruiting |
| Dothan, Alabama, United States, 36303 | |
| United States, Arizona | |
| Forest Investigative Site 005 | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Forest Investigative Site 055 | Recruiting |
| Tucson, Arizona, United States, 85718 | |
| United States, Arkansas | |
| Forest Investigative Site 077 | Recruiting |
| Little Rock, Arkansas, United States, 72202-3591 | |
| United States, California | |
| Forest Investigative Site 054 | Recruiting |
| Glendale, California, United States, 91206 | |
| Forest Investigative Site 109 | Recruiting |
| Imperial, California, United States, 92251 | |
| Forest Investigative Site 066 | Recruiting |
| Irvine, California, United States, 92612 | |
| Forest Investigative Site 096 | Recruiting |
| Los Angeles, California, United States, 90024 | |
| Forest Investigative Site 021 | Recruiting |
| San Francisco, California, United States, 94143-0984 | |
| Forest Investigative Site 026 | Recruiting |
| Santa Ana, California, United States, 92701 | |
| Forest Investigative Site 103 | Not yet recruiting |
| Santa Ana, California, United States, 92705 | |
| Forest Investigative Site 002 | Not yet recruiting |
| Stanford, California, United States, 94305-5719 | |
| United States, Colorado | |
| Forest Investigative Site 078 | Recruiting |
| Boulder, Colorado, United States, 80304 | |
| Forest Investigative Site 073 | Recruiting |
| Centennial, Colorado, United States, 80112 | |
| United States, Connecticut | |
| Forest Investigative Site 111 | Not yet recruiting |
| Hartford, Connecticut, United States, 06106 | |
| United States, District of Columbia | |
| Forest Investigative Site 052 | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| Forest Investigative Site 075 | Recruiting |
| Bradenton, Florida, United States, 32751 | |
| Forest Investigative Site 135 | Withdrawn |
| Destin, Florida, United States, 32541 | |
| Forest Investigative Site 080 | Recruiting |
| Gainesville, Florida, United States, 32607 | |
| Forest Investigative Site 122 | Not yet recruiting |
| Gulf Breeze, Florida, United States, 32561 | |
| Forest Investigative Site 089 | Not yet recruiting |
| Hialeah, Florida, United States, 33012 | |
| Forest Investigative Site 117 | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Forest Investigative Site 065 | Recruiting |
| Maitland, Florida, United States, 32751 | |
| Forest Investigative Site 110 | Withdrawn |
| Miami, Florida, United States, 33126 | |
| Forest Investigative Site 118 | Recruiting |
| Miami, Florida, United States, 33155 | |
| Forest Investigative Site 085 | Recruiting |
| Oakland Park, Florida, United States, 33334 | |
| Forest Investigative Site 115 | Recruiting |
| Orange City, Florida, United States, 32763 | |
| Forest Investigative Site 114 | Recruiting |
| Orlando, Florida, United States, 32839 | |
| Forest Investigative Site 062 | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Forest Investigative Site 124 | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Forest Investigative Site 125 | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Forest Investigative Site 067 | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Forest Investigative Site 101 | Recruiting |
| Wellington, Florida, United States, 33414 | |
| United States, Illinois | |
| Forest Investigative Site 102 | Recruiting |
| Libertyville, Illinois, United States, 60048 | |
| Forest Investigative Site 023 | Recruiting |
| Naperville, Illinois, United States, 60563 | |
| United States, Indiana | |
| Forest Investigative Site 082 | Recruiting |
| Evansville, Indiana, United States, 47713 | |
| Forest Investigative Site 123 | Recruiting |
| Fort Wayne, Indiana, United States, 46805 | |
| Forest Investigative Site 010 | Not yet recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Forest Investigative Site 084 | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Forest Investigative Site 056 | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| Forest Investigative Site 106 | Recruiting |
| Wichita, Kansas, United States, 67214-3199 | |
| United States, Kentucky | |
| Forest Investigative Site 061 | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Forest Investigative Site 074 | Recruiting |
| Owensboro, Kentucky, United States, 42301 | |
| United States, Louisiana | |
| Forest Investigative Site 095 | Recruiting |
| Lake Charles, Louisiana, United States, 70605 | |
| Forest Investigative Site 091 | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Forest Investigative Site 086 | Recruiting |
| Rockville, Maryland, United States, 20852 | |
| United States, Massachusetts | |
| Forest Investigative Site 025 | Not yet recruiting |
| Cambridge, Massachusetts, United States, 02138 | |
| Forest Investigative Site 088 | Not yet recruiting |
| Lexington, Massachusetts, United States, 02421 | |
| Forest Investigative Site 059 | Recruiting |
| Newton, Massachusetts, United States, 02459 | |
| Forest Investigative Site 108 | Recruiting |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Forest Investigative Site 099 | Not yet recruiting |
| Bloomfield Hills, Michigan, United States, 48302 | |
| Forest Investigative Site 112 | Withdrawn |
| Detroit, Michigan, United States, 48201 | |
| United States, Nebraska | |
| Forest Investigative Site 097 | Recruiting |
| Lincoln, Nebraska, United States, 68526 | |
| Forest Investigative Site 116 | Recruiting |
| Lincoln, Nebraska, United States, 68516 | |
| United States, Nevada | |
| Forest Investigative Site 130 | Recruiting |
| Henderson, Nevada, United States, 89052 | |
| Forest Investigative Site 104 | Recruiting |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Jersey | |
| Forest Investigative Site 136 | Recruiting |
| Neptune, New Jersey, United States, 07753 | |
| Forest Investigative Site 127 | Recruiting |
| Toms River, New Jersey, United States, 08755 | |
| United States, New Mexico | |
| Forest Investigative Site 081 | Recruiting |
| Albuquerque, New Mexico, United States, 87108-5129 | |
| Forest Investigative Site 107 | Recruiting |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Forest Investigative Site 098 | Recruiting |
| Bronx, New York, United States, 10467 | |
| Forest Investigative Site 083 | Not yet recruiting |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Forest Investigative Site 072 | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, North Dakota | |
| Forest Investigative Site 137 | Not yet recruiting |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Forest Investigative Site 069 | Recruiting |
| Avon Lake, Ohio, United States, 44012 | |
| Forest Investigative Site 015 | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Forest Investigative Site 134 | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Forest Investigative Site 126 | Not yet recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Forest Investigative Site 001 | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Forest Investigative Site 019 | Recruiting |
| Oklahoma City, Oklahoma, United States, 73116 | |
| Forest Investigative Site 092 | Recruiting |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Forest Investigative Site 053 | Recruiting |
| Gresham, Oregon, United States, 97030 | |
| Forest Investigative Site 133 | Not yet recruiting |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Forest Investigative Site 132 | Recruiting |
| Johnstown, Pennsylvania, United States, 15904 | |
| Forest Investigative Site 131 | Recruiting |
| McMurray, Pennsylvania, United States, 15317 | |
| Forest Investigative Site 100 | Recruiting |
| Media, Pennsylvania, United States, 19063 | |
| United States, South Carolina | |
| Forest Investigative Site 105 | Not yet recruiting |
| Charleston, South Carolina, United States, 29407 | |
| United States, South Dakota | |
| Forest Investigative Site 128 | Not yet recruiting |
| Sioux Falls, South Dakota, United States, 57105 | |
| Forest Investigative Site 129 | Not yet recruiting |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Tennessee | |
| Forest Investigative Site 090 | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| Forest Investigative Site 057 | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Forest Investigative Site 051 | Recruiting |
| Houston, Texas, United States, 77090 | |
| Forest Investigative Site 094 | Not yet recruiting |
| Houston, Texas, United States, 77054 | |
| Forest Investigative Site 070 | Recruiting |
| The Woodlands, Texas, United States, 77381 | |
| United States, Utah | |
| Forest Investigative Site 028 | Recruiting |
| Clinton, Utah, United States, 84015 | |
| Forest Investigative Site 141 | Recruiting |
| Ogden, Utah, United States, 84405 | |
| Forest Investigative Site 029 | Recruiting |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Virginia | |
| Forest Investigative Site 064 | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Forest Investigative Site 113 | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Forest Investigative Site 071 | Recruiting |
| Bothell, Washington, United States, 98011 | |
| Forest Investigative Site 121 | Not yet recruiting |
| Seattle, Washington, United States, 98121 | |
| United States, West Virginia | |
| Forest Investigative Site 119 | Recruiting |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| Forest Investigative Site 076 | Withdrawn |
| Madison, Wisconsin, United States, 53715 | |
| Forest Investigative Site 063 | Recruiting |
| Middleton, Wisconsin, United States, 53562 | |
| Forest Investigative Site 138 | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53201 | |
| Canada, Ontario | |
| Forest Investigative Site 152 | Not yet recruiting |
| Toronto, Ontario, Canada, M4G 1R8 | |
| Forest Investigative Site 153 | Not yet recruiting |
| Toronto, Ontario, Canada, M4S 1Y2 | |
| Forest Investigative Site 155 | Recruiting |
| Toronto, Ontario, Canada, M5B 1T8 | |
| Canada, Quebec | |
| Forest Investigative Site 151 | Not yet recruiting |
| Montreal, Quebec, Canada, H1Y3L1 | |
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: | NCT01592786 History of Changes |
| Other Study ID Numbers: | MEM-MD-91 |
| Study First Received: | May 3, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Public Health Agency of Canada |
Keywords provided by Forest Laboratories:
|
Autism Spectrum Disorder (ASD) Autism Autistic Disorder Asperger's Disorder Asperger's |
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Memantine Pervasive Child Development Disorder Pediatric 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