MedTrace Logo

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

NCT01999894 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2014-03-18

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Ephraim Katz, PhD · Forest Laboratories

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01999894 on ClinicalTrials.gov