NCT01999894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2009

Typical duration for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 18, 2014

Completed
Last Updated

March 18, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

November 26, 2013

Results QC Date

January 31, 2014

Last Update Submit

January 31, 2014

Conditions

AutismPediatric Autism

Keywords

NamendaAutismMemantinePediatricForest Laboratories

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)

    Number of patients who experienced one or more TEAEs during the study

    From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)

Study Arms (1)

Memantine

EXPERIMENTAL

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

Drug: Memantine HCl

Interventions

Memantine HClDRUG

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.

Also known as: Namenda, Namenda XR
Memantine

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a concurrent medical condition that might interfere with the conduct of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Forest Investigative Site 005

Phoenix, Arizona, 85006, United States

Location

Forest Investigative Site 003

Sacramento, California, 95817, United States

Location

Forest Investigative Site 021

San Francisco, California, 94143, United States

Location

Forest Investigative Site 026

Santa Ana, California, 92701, United States

Location

Forest Investigative Site 020

Santa Ana, California, 92705, United States

Location

Forest Investigative Site 002

Stanford, California, 94305, United States

Location

Forest Investigative Site 024

Jacksonville Beach, Florida, 32250, United States

Location

Forest Investigative Site 007

St. Petersburg, Florida, 33701, United States

Location

Forest Investigative Site 014

Hoffman Estates, Illinois, 60169, United States

Location

Forest Investigative Site 023

Naperville, Illinois, 60563, United States

Location

Forest Investigative Site 010

Indianapolis, Indiana, 46202, United States

Location

Forest Investigative Site 025

Cambridge, Massachusetts, 02138, United States

Location

Forest Investigative Site 011

Toms River, New Jersey, 08755, United States

Location

Forest Investigative Site 006

Voorhees Township, New Jersey, 08043, United States

Location

Forest Investigative Site 017

Manhasset, New York, 10030, United States

Location

Forest Investigative Site 013

Cleveland, Ohio, 44106, United States

Location

Forest Investigative Site 015

Cleveland, Ohio, 44106, United States

Location

Forest Investigative Site 001

Columbus, Ohio, 43210, United States

Location

Forest Investigative Site 019

Oklahoma City, Oklahoma, 73116, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Ephraim Katz, PhD / Associate Director
Organization
Forest Research Institute
Ephraim.Katz@frx.com
201-427-8000

Study Officials

  • Ephraim Katz, PhD

    Forest Laboratories

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 3, 2013

Study Start

November 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 18, 2014

Results First Posted

March 18, 2014

Record last verified: 2014-01

Locations

US(19)