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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01592786
Other study ID # MEM-MD-91
Secondary ID
Status Completed
Phase Phase 2
First received May 3, 2012
Last updated July 15, 2014
Start date June 2012
Est. completion date August 2013

Study information

Verified date July 2014
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: National Health and Medical Research CouncilBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Public Health Agency of CanadaColombia: Ministry of Health and Social ProtectionEstonia: The State Agency of MedicineFrance: Ministry of HealthHungary: Research Ethics Medical CommitteeIceland: Ministry of Health and Social SecurityItaly: Ethics CommitteeNew Zealand: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSingapore: Ministry of HealthSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Spanish Agency of MedicinesUkraine: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 906
Est. completion date August 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 12 Years
Eligibility 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Australia Forest Investigative Site 177 Camperdown New South Wales
Belgium Forest Investigative Site 204 Brussel
Belgium Forest Investigative Site 203 Bruxelles
Belgium Forest Investigative Site 202 Hoboken
Belgium Forest Investigative Site 201 Leuven
Canada Forest Investigative Site 155 Toronto Ontario
Colombia Forest Investigative Site 227 Barranquilla
Colombia Forest Investigative Site 228 Bello
Colombia Forest Investigative Site 226 Bogota
Estonia Forest Investigative Site 276 Tallinn
France Forest Investigative Site 329 Bron Rhone
France Forest Investigative Site 326 Paris
Hungary Forest Investigative Site 376 Budapest
Hungary Forest Investigative Site 378 Budapest
Hungary Forest Investigative Site 379 Budapest
Hungary Forest Investigative Site 381 Budapest
Hungary Forest Investigative Site 382 Gyula
Hungary Forest Investigative Site 380 Szeged
Iceland Forest Investigative Site 401 Kopavogur
Italy Forest Investigative Site 453 Roma
Italy Forest Investigative Site 452 Siena
Korea, Republic of Forest Investigative Site 701 Seoul
Korea, Republic of Forest Investigative Site 702 Seoul
Korea, Republic of Forest Investigative Site 703 Seoul
Korea, Republic of Forest Investigative Site 704 Yangsan-si Gyeongsangnam-do
New Zealand Forest Investigative Site 526 Wellington
Poland Forest Investigative Site 578 Gdansk
Poland Forest Investigative Site 579 Gdansk
Poland Forest Investigative Site 580 Kielce
Poland Forest Investigative Site 576 Kobierzyce
Poland Forest Investigative Site 577 Warszawa
Serbia Forest Investigative Site 626 Belgrade
Serbia Forest Investigative Site 627 Belgrade
Serbia Forest Investigative Site 629 Nis
Serbia Forest Investigative Site 628 Novi Sad
Singapore Forest Investigative Site 651 Singapore
South Africa Forest Investigative Site 676 Cape Town Western Cape
Spain Forest Investigative Site 729 Barcelona
Spain Forest Investigative Site 727 Madrid
Spain Forest Investigative Site 728 Sabadell Barcelona
Spain Forest Investigative Site 730 Torremolinos Málaga
Ukraine Forest Investigative Site 803 Donetsk
Ukraine Forest Investigative Site 807 Kharkiv
Ukraine Forest Investigative Site 802 Kherson Vil. Stepanivka
Ukraine Forest Investigative Site 804 Kyiv
Ukraine Forest Investigative Site 801 Odesa
United States Forest Investigative Site 081 Albuquerque New Mexico
United States Forest Investigative Site 107 Albuquerque New Mexico
United States Forest Investigative Site 069 Avon Lake Ohio
United States Forest Investigative Site 071 Bothell Washington
United States Forest Investigative Site 078 Boulder Colorado
United States Forest Investigative Site 075 Bradenton Florida
United States Forest Investigative Site 098 Bronx New York
United States Forest Investigative Site 073 Centennial Colorado
United States Forest Investigative Site 072 Chapel Hill North Carolina
United States Forest Investigative Site 105 Charleston South Carolina
United States Forest Investigative Site 119 Charleston West Virginia
United States Forest Investigative Site 064 Charlottesville Virginia
United States Forest Investigative Site 028 Clinton Utah
United States Forest Investigative Site 001 Columbus Ohio
United States Forest Investigative Site 068 Dothan Alabama
United States Forest Investigative Site 082 Evansville Indiana
United States Forest Investigative Site 123 Fort Wayne Indiana
United States Forest Investigative Site 080 Gainesville Florida
United States Forest Investigative Site 054 Glendale California
United States Forest Investigative Site 053 Gresham Oregon
United States Forest Investigative Site 130 Henderson Nevada
United States Forest Investigative Site 051 Houston Texas
United States Forest Investigative Site 109 Imperial California
United States Forest Investigative Site 056 Indianapolis Indiana
United States Forest Investigative Site 084 Indianapolis Indiana
United States Forest Investigative Site 066 Irvine California
United States Forest Investigative Site 117 Jacksonville Florida
United States Forest Investigative Site 132 Johnstown Pennsylvania
United States Forest Investigative Site 095 Lake Charles Louisiana
United States Forest Investigative Site 104 Las Vegas Nevada
United States Forest Investigative Site 102 Libertyville Illinois
United States Forest Investigative Site 097 Lincoln Nebraska
United States Forest Investigative Site 116 Lincoln Nebraska
United States Forest Investigative Site 077 Little Rock Arkansas
United States Forest Investigative Site 096 Los Angeles California
United States Forest Investigative Site 061 Louisville Kentucky
United States Forest Investigative Site 065 Maitland Florida
United States Forest Investigative Site 131 McMurray Pennsylvania
United States Forest Investigative Site 100 Media Pennsylvania
United States Forest Investigative Site 090 Memphis Tennessee
United States Forest Investigative Site 118 Miami Florida
United States Forest Investigative Site 063 Middleton Wisconsin
United States Forest Investigative Site 023 Naperville Illinois
United States Forest Investigative Site 057 Nashville Tennessee
United States Forest Investigative Site 136 Neptune New Jersey
United States Forest Investigative Site 091 New Orleans Louisiana
United States Forest Investigative Site 059 Newton Massachusetts
United States Forest Investigative Site 113 Norfolk Virginia
United States Forest Investigative Site 085 Oakland Park Florida
United States Forest Investigative Site 141 Ogden Utah
United States Forest Investigative Site 019 Oklahoma City Oklahoma
United States Forest Investigative Site 115 Orange City Florida
United States Forest Investigative Site 062 Orlando Florida
United States Forest Investigative Site 114 Orlando Florida
United States Forest Investigative Site 124 Orlando Florida
United States Forest Investigative Site 125 Orlando Florida
United States Forest Investigative Site 074 Owensboro Kentucky
United States Forest Investigative Site 005 Phoenix Arizona
United States Forest Investigative Site 086 Rockville Maryland
United States Forest Investigative Site 029 Salt Lake City Utah
United States Forest Investigative Site 021 San Francisco California
United States Forest Investigative Site 026 Santa Ana California
United States Forest Investigative Site 108 Springfield Massachusetts
United States Forest Investigative Site 002 Stanford California
United States Forest Investigative Site 067 Tampa Florida
United States Forest Investigative Site 070 The Woodlands Texas
United States Forest Investigative Site 127 Toms River New Jersey
United States Forest Investigative Site 055 Tucson Arizona
United States Forest Investigative Site 092 Tulsa Oklahoma
United States Forest Investigative Site 052 Washington District of Columbia
United States Forest Investigative Site 101 Wellington Florida
United States Forest Investigative Site 106 Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Colombia,  Estonia,  France,  Hungary,  Iceland,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Serbia,  Singapore,  South Africa,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Confirmed Social Responsiveness Scale (SRS) Responders 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) No
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