NCT00872898

Brief Summary

The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

17 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

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 14, 2014

Completed
Last Updated

January 14, 2014

Status Verified

November 1, 2013

Enrollment Period

3.3 years

First QC Date

March 30, 2009

Results QC Date

August 1, 2013

Last Update Submit

November 26, 2013

Conditions

Autism

Keywords

autismmemantinepediatricForest LaboratoriesAutism in pediatric patients

Outcome Measures

Primary Outcomes (2)

  • Extent of Absorption of Memantine (Part One)

    Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.

    Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose

  • Change in Total Raw Score of Social Responsiveness Scale

    The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, ranging from 0 (no impairment) to 195 (severe social impairment). Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment.

    From Baseline to Week 12

Secondary Outcomes (13)

  • Core Autism Treatment Scale-Improvement: Total Score

    At Week 12

  • Core Autism Treatment Scale-Improvement: Social Interaction

    At Week 12

  • Core Autism Treatment Scale-Improvement: Communication

    At Week 12

  • Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale

    From Baseline to Week 12

  • Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale

    From Baseline to Week 12

  • +8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Once daily oral administration of memantine for 12 weeks.

Drug: Memantine - Extended Release (ER)

2

PLACEBO COMPARATOR

Once daily oral administration of placebo for 12 weeks.

Drug: Placebo

Interventions

Memantine - Extended Release (ER)DRUG

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Also known as: Namenda ER
1
PlaceboDRUG

Placebo capsules, once daily, oral administration.

2

Eligibility Criteria

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

You may qualify if:

  • Males or females ages 6 to 12 years
  • Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 \& 3).
  • A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
  • Patients over age 12, only if they completed Study MEM-PK-21

You may not qualify if:

  • Medical history of active epilepsy/seizure disorder except simple febrile seizures
  • Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Forest Investigative Site

Phoenix, Arizona, 85006, United States

Location

Forest Investigative Site

Sacramento, California, 95817, United States

Location

Forest Investigative Site

San Francisco, California, 94143, United States

Location

Forest Investigative Site

Santa Ana, California, 92705, United States

Location

Forest Investigative Site

Stanford, California, 94305, United States

Location

Forest Investigative Site

Jacksonville Beach, Florida, 32250, United States

Location

Forest Investigative Site

St. Petersburg, Florida, 33701, United States

Location

Forest Investigative Site

Hoffman Estates, Illinois, 60169, United States

Location

Forest Investigative site

Naperville, Illinois, 60563, United States

Location

Forest Investigative Site

Indianapolis, Indiana, 46202, United States

Location

Forest Investigative Site

Cambridge, Massachusetts, 02138, United States

Location

Forest Investigative Site

Toms River, New Jersey, 08755, United States

Location

Forest Investigative Site

Voorhees Township, New Jersey, 08043, United States

Location

Forest Investigative Site

Manhasset, New York, 11030, United States

Location

Forest Investigative Site

Cleveland, Ohio, 44106, United States

Location

Forest Investigative Site

Columbus, Ohio, 43210, United States

Location

Forest Investigative Site

Oklahoma City, Oklahoma, 73116, United States

Location

Related Publications (2)

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PMID: 37811711DERIVED

  • Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.

    PMID: 36006807DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

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 Research Institute, a subsidiary of Forest Laboratories, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2012

Last Updated

January 14, 2014

Results First Posted

January 14, 2014

Record last verified: 2013-11

Locations

US(17)