Open-label Study of Safety and Tolerability of Memantine in Children With Autism
NCT ID: NCT01999894
Last Updated: 2014-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2009-11-30
2013-02-28
Brief Summary
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Detailed Description
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In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats.
The weight-based dose limits in these studies were as follows:
* Group A: ≥ 60 kg; max 15 mg/day
* Group B: 40-59 kg; max 9 mg/day
* Group C: 20-39 kg; max 6 mg/day
* Group D: \< 20 kg; max 3 mg/day
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Memantine
Once daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period.
Memantine HCl
Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.
Interventions
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Memantine HCl
Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
Exclusion Criteria
6 Years
18 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Ephraim Katz, PhD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 005
Phoenix, Arizona, United States
Forest Investigative Site 003
Sacramento, California, United States
Forest Investigative Site 021
San Francisco, California, United States
Forest Investigative Site 026
Santa Ana, California, United States
Forest Investigative Site 020
Santa Ana, California, United States
Forest Investigative Site 002
Stanford, California, United States
Forest Investigative Site 024
Jacksonville Beach, Florida, United States
Forest Investigative Site 007
St. Petersburg, Florida, United States
Forest Investigative Site 014
Hoffman Estates, Illinois, United States
Forest Investigative Site 023
Naperville, Illinois, United States
Forest Investigative Site 010
Indianapolis, Indiana, United States
Forest Investigative Site 025
Cambridge, Massachusetts, United States
Forest Investigative Site 011
Toms River, New Jersey, United States
Forest Investigative Site 006
Voorhees Township, New Jersey, United States
Forest Investigative Site 017
Manhasset, New York, United States
Forest Investigative Site 013
Cleveland, Ohio, United States
Forest Investigative Site 015
Cleveland, Ohio, United States
Forest Investigative Site 001
Columbus, Ohio, United States
Forest Investigative Site 019
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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MEM-MD-67
Identifier Type: -
Identifier Source: org_study_id
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