Open-label Study of Safety and Tolerability of Memantine in Children With Autism

Phase 2

Completed

• Conditions: Autism; Pediatric Autism
• Interventions: Drug: Memantine HCl

• Registration Number: NCT01999894
• Lead Sponsor: Forest Laboratories

Brief 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.

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

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-03
• Status Verified: 2014-01
• Results First Submitted: 2014-01-31
• Results First Submitted QC: 2014-01-31
• Last Update Submitted: 2014-01-31
• Results First Posted: 2014-03-18
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Memantine	Memantine HCl	Once daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period.

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)	From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)	Number of patients who experienced one or more TEAEs during the study

Trial Locations

Locations (19)

Forest Investigative Site 024; 🇺🇸 Jacksonville Beach, Florida, United States

Forest Investigative Site 013; 🇺🇸 Cleveland, Ohio, United States

Forest Investigative Site 006; 🇺🇸 Voorhees, New Jersey, United States

Forest Investigative Site 011; 🇺🇸 Toms River, New Jersey, United States

Forest Investigative Site 005; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 021; 🇺🇸 San Francisco, California, United States

Forest Investigative Site 003; 🇺🇸 Sacramento, California, United States

Forest Investigative Site 020; 🇺🇸 Santa Ana, California, United States

Forest Investigative Site 026; 🇺🇸 Santa Ana, California, United States

Forest Investigative Site 002; 🇺🇸 Stanford, California, 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 017; 🇺🇸 Manhasset, New York, United States

Forest Investigative Site 015; 🇺🇸 Cleveland, Ohio, United States

Forest Investigative Site 019; 🇺🇸 Oklahoma, Oklahoma, United States

Forest Investigative Site 001; 🇺🇸 Columbus, Ohio, United States