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

January 30, 2015 updated by: Forest Laboratories

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This clinical study was a 48-week, multicenter, multinational, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at 106 study centers. Patients were eligible for this long-term extension study if they had:

  • completed the open-label Study MEM MD 67,or
  • completed the open-label Study MEM-MD-91, or
  • completed the double-blind Study MEM-MD-68, or
  • discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response

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

The decision to close the study early was based on data from 2 double-blind placebo-controlled studies (MEM-MD-57A and MEM-MD-68) that failed to demonstrate a statistically significant difference between memantine and placebo in the primary efficacy parameter based on Social Responsiveness Scale (SRS) total raw score.

Study Type

Interventional

Enrollment (Actual)

747

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

  • Belgium
      • Brussels, Belgium, 1020
        • Forest Investigative Site 204
      • Jette, Belgium, 1090
        • Forest Investigative Site 203
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1T8
        • Forest Investigative Site 155
  • Colombia
      • Barranquilla, Colombia, 84176
        • Forest Investigative Site 227
      • Bogota, Colombia
        • Forest Investigative Site 226
    • Bello
      • Antioquia, Bello, Colombia
        • Forest Investigative Site 228
  • Estonia
      • Tallinn, Estonia, 10617
        • Forest Investigative Site 276
  • France
    • Rhone
      • Bron Cedex, 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
      • Gyula, Hungary, 5700
        • Forest Investigative Site 382
  • Iceland
      • Kopavogur, Iceland, 200
        • Forest Investigative Site 401
  • Italy
      • Roma, Italy, 00165
        • 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, 120752
        • Forest Investigative Site 703
      • Seoul, Korea, Republic of, 138736
        • Forest Investigative Site 701
    • Gyeongsangnam-do
      • Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 626-770
        • Forest Investigative Site 704
  • New Zealand
      • Wellington, New Zealand, 7902
        • Forest Investigative Site 526
  • Poland
      • Gdansk, Poland, 80542
        • Forest Investigative Site 579
      • Gdansk, Poland, 80952
        • Forest Investigative Site 578
      • Kielce, Poland, 25317
        • Forest Investigative Site 580
      • Tyniec Maly, Poland, 55040
        • Forest Investigative Site 576
      • Warsaw, Poland, 80214
        • 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
  • South Africa
      • Bellville Cape Town, South Africa, 7530
        • Forest Investigative Site 676
  • Spain
      • Barcelona, Spain, 08221
        • Forest Investigative Site 729
      • Sabadell, Spain, 08208
        • Forest Investigative Site 728
      • Torremolinos, Spain, 29620
        • Forest Investigative Site 730
  • Ukraine
      • Donetsk, Ukraine, 83008
        • Forest Investigative Site 803
      • Kharkiv, Ukraine, 61153
        • Forest Investigative Site 807
      • Kherson, Ukraine, 73488
        • Forest Investigative Site 802
      • Kyiv, Ukraine, 4080
        • Forest Investigative Site 804
      • Odessa, Ukraine, 65014
        • Forest Investigative Site 801
  • 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
      • Tampa, Florida, United States, 33613
        • 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
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Forest Investigative Site 061
    • 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
      • Roanoke, Virginia, United States, 24014
        • Forest Investigative Site 124
    • 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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
  • Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
  • 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:

  • Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
  • Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
  • Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior

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

To maintain the blind of the preceding study, patients who participated in MEM-MD-68 (NCT01592747) began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.

Patients who took open-label memantine in study MEM-MD-67 (NCT01999894) or MEM-MD-91(NCT01592786), received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
Drug: Memantine Hydrochloride (HCl)

During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily.

During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.

Other Names:
  • Namenda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With Any Treatment-emergent Adverse Event
Time Frame: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

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)

February 16, 2015

Last Update Submitted That Met QC Criteria

January 30, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM-MD-69

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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