Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01592773
First received: May 3, 2012
Last updated: June 5, 2014
Last verified: June 2014
  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:


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


Enrollment: 748
Study Start Date: September 2012
Study Completion Date: April 2014
Primary Completion Date: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592773

  Hide Study Locations
Locations
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
Forest Investigative Site 066
Irvine, California, United States, 92612
Forest Investigative Site 096
Los Angeles, California, United States, 90024
Forest Investigative Site 021
San Francisco, California, United States, 94143-0984
Forest Investigative Site 026
Santa Ana, California, United States, 92701
Forest Investigative Site 002
Stanford, California, United States, 94305-5719
United States, Colorado
Forest Investigative Site 078
Boulder, Colorado, United States, 80304
Forest Investigative Site 073
Centennial, Colorado, United States, 80112
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
Forest Investigative Site 080
Gainesville, Florida, United States, 32607
Forest Investigative Site 117
Jacksonville, Florida, United States, 32216
Forest Investigative Site 065
Maitland, Florida, United States, 32751
Forest Investigative Site 118
Miami, Florida, United States, 33155
Forest Investigative Site 085
Oakland Park, Florida, United States, 33334
Forest Investigative Site 115
Orange City, Florida, United States, 32763
Forest Investigative Site 062
Orlando, Florida, United States, 32806
Forest Investigative Site 125
Orlando, Florida, United States, 32803
Forest Investigative Site 067
Tampa, Florida, United States, 33613
Forest Investigative Site 101
Wellington, Florida, United States, 33414
United States, Illinois
Forest Investigative Site 102
Libertyville, Illinois, United States, 60048
Forest Investigative Site 023
Naperville, Illinois, United States, 60563
United States, Indiana
Forest Investigative Site 082
Evansville, Indiana, United States, 47713
Forest Investigative Site 123
Fort Wayne, Indiana, United States, 46805
Forest Investigative Site 056
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Forest Investigative Site 061
Louisville, Kentucky, United States, 40202
United States, Louisiana
Forest Investigative Site 095
Lake Charles, Louisiana, United States, 70605
Forest Investigative Site 091
New Orleans, Louisiana, United States, 70112
United States, Maryland
Forest Investigative Site 086
Rockville, Maryland, United States, 20852
United States, Massachusetts
Forest Investigative Site 059
Newton, Massachusetts, United States, 02459
Forest Investigative Site 108
Springfield, Massachusetts, United States, 01199
United States, Nebraska
Forest Investigative Site 097
Lincoln, Nebraska, United States, 68526
Forest Investigative Site 116
Lincoln, Nebraska, United States, 68516
United States, Nevada
Forest Investigative Site 130
Henderson, Nevada, United States, 89052
Forest Investigative Site 104
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Forest Investigative Site 136
Neptune, New Jersey, United States, 07753
Forest Investigative Site 127
Toms River, New Jersey, United States, 08755
United States, New Mexico
Forest Investigative Site 081
Albuquerque, New Mexico, United States, 87108-5129
Forest Investigative Site 107
Albuquerque, New Mexico, United States, 87109
United States, New York
Forest Investigative Site 098
Bronx, New York, United States, 10467
United States, North Carolina
Forest Investigative Site 072
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Forest Investigative Site 069
Avon Lake, Ohio, United States, 44012
Forest Investigative Site 001
Columbus, Ohio, United States, 43210
United States, Oklahoma
Forest Investigative Site 019
Oklahoma City, Oklahoma, United States, 73116
Forest Investigative Site 092
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Forest Investigative Site 053
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Forest Investigative Site 132
Johnstown, Pennsylvania, United States, 15904
Forest Investigative Site 131
McMurray, Pennsylvania, United States, 15317
Forest Investigative Site 100
Media, Pennsylvania, United States, 19063
United States, South Carolina
Forest Investigative Site 105
Charleston, South Carolina, United States, 29407
United States, Tennessee
Forest Investigative Site 090
Memphis, Tennessee, United States, 38119
Forest Investigative Site 057
Nashville, Tennessee, United States, 37232
United States, Texas
Forest Investigative Site 051
Houston, Texas, United States, 77090
Forest Investigative Site 070
The Woodlands, Texas, United States, 77381
United States, Utah
Forest Investigative Site 028
Clinton, Utah, United States, 84015
Forest Investigative Site 141
Ogden, Utah, United States, 84405
Forest Investigative Site 029
Salt Lake City, Utah, United States, 84106
United States, Virginia
Forest Investigative Site 064
Charlottesville, Virginia, United States, 22903
Forest Investigative Site 113
Norfolk, Virginia, United States, 23507
Forest Investigative Site 124
Roanoke, Virginia, United States, 24014
United States, Washington
Forest Investigative Site 071
Bothell, Washington, United States, 98011
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
Belgium
Forest Investigative Site 204
Brussels, Belgium, 1020
Forest Investigative Site 202
Hoboken, Belgium, 2660
Forest Investigative Site 203
Jette, Belgium, 1090
Canada, Ontario
Forest Investigative Site 155
Toronto, Ontario, Canada, M5B 1T8
Colombia
Forest Investigative Site 228
Antioquia, Bello, Colombia
Forest Investigative Site 227
Barranquilla, Colombia, 84176
Forest Investigative Site 226
Bogota, Colombia
Estonia
Forest Investigative Site 276
Tallinn, Estonia, 10617
France
Forest Investigative Site 329
Bron Cedex, Rhone, France, 69500
Hungary
Forest Investigative Site 378
Budapest, Hungary, 1089
Forest Investigative Site 376
Budapest, Hungary, 1083
Forest Investigative Site 381
Budapest, Hungary, 1026
Forest Investigative Site 379
Budapest, Hungary, 1021
Forest Investigative Site 382
Gyula, Hungary, 5700
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 704
Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 626-770
Forest Investigative Site 701
Seoul, Korea, Republic of, 138736
Forest Investigative Site 702
Seoul, Korea, Republic of, 110744
Forest Investigative Site 703
Seoul, Korea, Republic of, 120752
New Zealand
Forest Investigative Site 526
Wellington, New Zealand, 7902
Poland
Forest Investigative Site 578
Gdansk, Poland, 80952
Forest Investigative Site 579
Gdansk, Poland, 80542
Forest Investigative Site 580
Kielce, Poland, 25317
Forest Investigative Site 576
Tyniec Maly, Poland, 55040
Forest Investigative Site 577
Warsaw, Poland, 80214
Serbia
Forest Investigative Site 626
Belgrade, Serbia, 11000
Forest Investigative Site 627
Belgrade, Serbia, 11000
Forest Investigative Site 629
Nis, Serbia, 18000
Forest Investigative Site 628
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 803
Donetsk, Ukraine, 83008
Forest Investigative Site 807
Kharkiv, Ukraine, 61153
Forest Investigative Site 802
Kherson, Ukraine, 73488
Forest Investigative Site 802
Kherson,Vil. Stepanivka, Ukraine, 73488
Forest Investigative Site 804
Kyiv, Ukraine, 4080
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: June 5, 2014
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 July 22, 2014