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

July 15, 2014 updated by: Forest Laboratories

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks).

Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in this study were as follows:

  • Group A: ≥ 60 kg; maximum 15 mg/day
  • Group B: 40-59 kg; maximum 9 mg/day
  • Group C: 20-39 kg; maximum 6 mg/day
  • Group D: < 20 kg; maximum 3 mg/day

Study Type

Interventional

Enrollment (Actual)

906

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Forest Investigative Site 177
  • Belgium
      • Brussel, Belgium, 1020
        • Forest Investigative Site 204
      • Bruxelles, Belgium, 1090
        • Forest Investigative Site 203
      • Hoboken, Belgium, 2660
        • Forest Investigative Site 202
      • Leuven, Belgium, 3000
        • Forest Investigative Site 201
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1T8
        • Forest Investigative Site 155
  • Colombia
      • Barranquilla, Colombia
        • Forest Investigative Site 227
      • Bello, Colombia
        • Forest Investigative Site 228
      • Bogota, Colombia
        • Forest Investigative Site 226
  • Estonia
      • Tallinn, Estonia, 10617
        • Forest Investigative Site 276
  • France
      • Paris, France, 75935
        • Forest Investigative Site 326
    • Rhone
      • Bron, Rhone, France, 69500
        • Forest Investigative Site 329
  • Hungary
      • Budapest, Hungary, 1026
        • Forest Investigative Site 381
      • Budapest, Hungary, 1083
        • Forest Investigative Site 376
      • Budapest, Hungary, 1089
        • Forest Investigative Site 378
      • Budapest, Hungary, 1021
        • Forest Investigative Site 379
      • Gyula, Hungary, 5700
        • Forest Investigative Site 382
      • Szeged, Hungary, 6725
        • Forest Investigative Site 380
  • Iceland
      • Kopavogur, Iceland, 200
        • Forest Investigative Site 401
  • Italy
      • Roma, Italy, 165
        • Forest Investigative Site 453
      • Siena, Italy, 53100
        • Forest Investigative Site 452
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110744
        • Forest Investigative Site 702
      • Seoul, Korea, Republic of, 120-752
        • Forest Investigative Site 703
      • Seoul, Korea, Republic of, 138-736
        • Forest Investigative Site 701
    • Gyeongsangnam-do
      • Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 626-770
        • Forest Investigative Site 704
  • New Zealand
      • Wellington, New Zealand, 6012
        • Forest Investigative Site 526
  • Poland
      • Gdansk, Poland, 80-542
        • Forest Investigative Site 579
      • Gdansk, Poland, 80-952
        • Forest Investigative Site 578
      • Kielce, Poland, 25-317
        • Forest Investigative Site 580
      • Kobierzyce, Poland, 55-040
        • Forest Investigative Site 576
      • Warszawa, Poland, 02-957
        • Forest Investigative Site 577
  • Serbia
      • Belgrade, Serbia, 11000
        • Forest Investigative Site 626
      • Belgrade, Serbia, 11000
        • Forest Investigative Site 627
      • Nis, Serbia, 18000
        • Forest Investigative Site 629
      • Novi Sad, Serbia, 21000
        • Forest Investigative Site 628
  • Singapore
      • Singapore, Singapore, 539747
        • Forest Investigative Site 651
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7530
        • Forest Investigative Site 676
  • Spain
      • Barcelona, Spain, 8221
        • Forest Investigative Site 729
      • Madrid, Spain, 28031
        • Forest Investigative Site 727
    • Barcelona
      • Sabadell, Barcelona, Spain, 8208
        • Forest Investigative Site 728
    • Málaga
      • Torremolinos, Málaga, Spain, 29620
        • Forest Investigative Site 730
  • Ukraine
      • Donetsk, Ukraine, 83008
        • Forest Investigative Site 803
      • Kharkiv, Ukraine, 61153
        • Forest Investigative Site 807
      • Kyiv, Ukraine, 4080
        • Forest Investigative Site 804
      • Odesa, Ukraine, 65014
        • Forest Investigative Site 801
    • Vil. Stepanivka
      • Kherson, Vil. Stepanivka, Ukraine, 73488
        • Forest Investigative Site 802
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Forest Investigative Site 068
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Forest Investigative Site 005
      • Tucson, Arizona, United States, 85718
        • Forest Investigative Site 055
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3591
        • Forest Investigative Site 077
    • California
      • Glendale, California, United States, 91206
        • Forest Investigative Site 054
      • Imperial, California, United States, 92251
        • Forest Investigative Site 109
      • Irvine, California, United States, 92612
        • Forest Investigative Site 066
      • Los Angeles, California, United States, 90024
        • Forest Investigative Site 096
      • San Francisco, California, United States, 94143-0984
        • Forest Investigative Site 021
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 026
      • Stanford, California, United States, 94305-5719
        • Forest Investigative Site 002
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Forest Investigative Site 078
      • Centennial, Colorado, United States, 80112
        • Forest Investigative Site 073
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Forest Investigative Site 052
    • Florida
      • Bradenton, Florida, United States, 32751
        • Forest Investigative Site 075
      • Gainesville, Florida, United States, 32607
        • Forest Investigative Site 080
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site 117
      • Maitland, Florida, United States, 32751
        • Forest Investigative Site 065
      • Miami, Florida, United States, 33155
        • Forest Investigative Site 118
      • Oakland Park, Florida, United States, 33334
        • Forest Investigative Site 085
      • Orange City, Florida, United States, 32763
        • Forest Investigative Site 115
      • Orlando, Florida, United States, 32803
        • Forest Investigative Site 125
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 062
      • Orlando, Florida, United States, 32803
        • Forest Investigative Site 124
      • Orlando, Florida, United States, 32839
        • Forest Investigative Site 114
      • Tampa, Florida, United States, 33612
        • Forest Investigative Site 067
      • Wellington, Florida, United States, 33414
        • Forest Investigative Site 101
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Forest Investigative Site 102
      • Naperville, Illinois, United States, 60563
        • Forest Investigative Site 023
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Forest Investigative Site 082
      • Fort Wayne, Indiana, United States, 46805
        • Forest Investigative Site 123
      • Indianapolis, Indiana, United States, 46260
        • Forest Investigative Site 056
      • Indianapolis, Indiana, United States, 46260
        • Forest Investigative Site 084
    • Kansas
      • Wichita, Kansas, United States, 67214-3199
        • Forest Investigative Site 106
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Forest Investigative Site 061
      • Owensboro, Kentucky, United States, 42301
        • Forest Investigative Site 074
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Forest Investigative Site 095
      • New Orleans, Louisiana, United States, 70112
        • Forest Investigative Site 091
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Forest Investigative Site 086
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Forest Investigative Site 059
      • Springfield, Massachusetts, United States, 01199
        • Forest Investigative Site 108
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Forest Investigative Site 116
      • Lincoln, Nebraska, United States, 68526
        • Forest Investigative Site 097
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Forest Investigative Site 130
      • Las Vegas, Nevada, United States, 89128
        • Forest Investigative Site 104
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Forest Investigative Site 136
      • Toms River, New Jersey, United States, 08755
        • Forest Investigative Site 127
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5129
        • Forest Investigative Site 081
      • Albuquerque, New Mexico, United States, 87109
        • Forest Investigative Site 107
    • New York
      • Bronx, New York, United States, 10467
        • Forest Investigative Site 098
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Forest Investigative Site 072
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Forest Investigative Site 069
      • Columbus, Ohio, United States, 43210
        • Forest Investigative Site 001
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Forest Investigative Site 019
      • Tulsa, Oklahoma, United States, 74104
        • Forest Investigative Site 092
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Forest Investigative Site 053
    • Pennsylvania
      • Johnstown, Pennsylvania, United States, 15904
        • Forest Investigative Site 132
      • McMurray, Pennsylvania, United States, 15317
        • Forest Investigative Site 131
      • Media, Pennsylvania, United States, 19063
        • Forest Investigative Site 100
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Forest Investigative Site 105
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 090
      • Nashville, Tennessee, United States, 37232
        • Forest Investigative Site 057
    • Texas
      • Houston, Texas, United States, 77090
        • Forest Investigative Site 051
      • The Woodlands, Texas, United States, 77381
        • Forest Investigative Site 070
    • Utah
      • Clinton, Utah, United States, 84015
        • Forest Investigative Site 028
      • Ogden, Utah, United States, 84405
        • Forest Investigative Site 141
      • Salt Lake City, Utah, United States, 84106
        • Forest Investigative Site 029
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Forest Investigative Site 064
      • Norfolk, Virginia, United States, 23507
        • Forest Investigative Site 113
    • Washington
      • Bothell, Washington, United States, 98011
        • Forest Investigative Site 071
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Forest Investigative Site 119
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Forest Investigative Site 063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Memantine Hydrochloride (HCl)
Once daily oral administration of open-label memantine for up to 48 weeks: 6-week dose-titration period followed by up to 42-week maintenance period.
Drug: Memantine Hydrochloride (HCl)
Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.
Other Names:
  • Namenda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Confirmed Social Responsiveness Scale (SRS) Responders
Time Frame: Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Jordan Lateiner, MS, MBA, Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM-MD-91

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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