Open-label Study of Safety and Tolerability of Memantine in Children With Autism
Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autism; Pediatric Autism
Intervention: Memantine HCl (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Forest Laboratories Official(s) and/or principal investigator(s):
Ephraim Katz, PhD, Study Director, Affiliation: Forest Laboratories
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of memantine
in the treatment of autism in pediatric patients.
Clinical Details
Official title: An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
Detailed description:
This is a 48-week multicenter extension study comprised of a 6-week double-blind
dose-titration period followed by a 42-week open-label maintenance period.
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
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Completed lead-in study MEM-MD-57A (NCT00872898)
- A knowledgeable caregiver capable of providing reliable information about the
patient's condition, able to attend all clinic visits with the patient
Exclusion Criteria:
- Patients with a concurrent medical condition that might interfere with the conduct of
the study
Locations and Contacts
Forest Investigative Site 005, Phoenix, Arizona 85006, United States
Forest Investigative Site 003, Sacramento, California 95817, United States
Forest Investigative Site 021, San Francisco, California 94143, United States
Forest Investigative Site 020, Santa Ana, California 92705, United States
Forest Investigative Site 026, Santa Ana, California 92701, United States
Forest Investigative Site 002, Stanford, California 94305, United States
Forest Investigative Site 024, Jacksonville Beach, Florida 32250, United States
Forest Investigative Site 007, St. Petersburg, Florida 33701, United States
Forest Investigative Site 014, Hoffman Estates, Illinois 60169, United States
Forest Investigative Site 023, Naperville, Illinois 60563, United States
Forest Investigative Site 010, Indianapolis, Indiana 46202, United States
Forest Investigative Site 025, Cambridge, Massachusetts 02138, United States
Forest Investigative Site 011, Toms River, New Jersey 08755, United States
Forest Investigative Site 006, Voorhees, New Jersey 08043, United States
Forest Investigative Site 017, Manhasset, New York 10030, United States
Forest Investigative Site 013, Cleveland, Ohio 44106, United States
Forest Investigative Site 015, Cleveland, Ohio 44106, United States
Forest Investigative Site 001, Columbus, Ohio 43210, United States
Forest Investigative Site 019, Oklahoma, Oklahoma 73116, United States
Additional Information
Starting date: November 2009
Last updated: January 31, 2014
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