An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

NCT ID: NCT01592786

Last Updated: 2014-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 906 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

Detailed Description

This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks).

Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in this study were as follows:

• Group A: ≥ 60 kg; maximum 15 mg/day
• Group B: 40-59 kg; maximum 9 mg/day
• Group C: 20-39 kg; maximum 6 mg/day
• Group D: < 20 kg; maximum 3 mg/day

Conditions

Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Memantine Hydrochloride (HCl)

Once daily oral administration of open-label memantine for up to 48 weeks: 6-week dose-titration period followed by up to 42-week maintenance period.

Group Type: EXPERIMENTAL

Memantine Hydrochloride (HCl)

Intervention Type: DRUG

Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.

Interventions

Memantine Hydrochloride (HCl)

Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.

Intervention Type: DRUG

Other Intervention Names

Namenda

Eligibility Criteria

Inclusion Criteria

1. Male or female outpatients.

2. Age of 6-12.

3. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

4. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study

Exclusion Criteria

1. Have enrolled in Study MEM-MD-57A

2. Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being.

3. Participation in any other clinical investigation using an experimental drug within 30 days of screening.

4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS.

5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordan Lateiner, MS, MBA

Role: STUDY_DIRECTOR

Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.

Locations

Forest Investigative Site 068

Dothan, Alabama, United States

Forest Investigative Site 005

Phoenix, Arizona, United States

Forest Investigative Site 055

Tucson, Arizona, United States

Forest Investigative Site 077

Little Rock, Arkansas, United States

Forest Investigative Site 054

Glendale, California, United States

Forest Investigative Site 109

Imperial, California, United States

Forest Investigative Site 066

Irvine, California, United States

Forest Investigative Site 096

Los Angeles, California, United States

Forest Investigative Site 021

San Francisco, California, United States

Forest Investigative Site 026

Santa Ana, California, United States

Forest Investigative Site 002

Stanford, California, United States

Forest Investigative Site 078

Boulder, Colorado, United States

Forest Investigative Site 073

Centennial, Colorado, United States

Forest Investigative Site 052

Washington D.C., District of Columbia, United States

Forest Investigative Site 075

Bradenton, Florida, United States

Forest Investigative Site 080

Gainesville, Florida, United States

Forest Investigative Site 117

Jacksonville, Florida, United States

Forest Investigative Site 065

Maitland, Florida, United States

Forest Investigative Site 118

Miami, Florida, United States

Forest Investigative Site 085

Oakland Park, Florida, United States

Forest Investigative Site 115

Orange City, Florida, United States

Forest Investigative Site 124

Orlando, Florida, United States

Forest Investigative Site 125

Orlando, Florida, United States

Forest Investigative Site 062

Orlando, Florida, United States

Forest Investigative Site 114

Orlando, Florida, United States

Forest Investigative Site 067

Tampa, Florida, United States

Forest Investigative Site 101

Wellington, Florida, United States

Forest Investigative Site 102

Libertyville, Illinois, United States

Forest Investigative Site 023

Naperville, Illinois, United States

Forest Investigative Site 082

Evansville, Indiana, United States

Forest Investigative Site 123

Fort Wayne, Indiana, United States

Forest Investigative Site 056

Indianapolis, Indiana, United States

Forest Investigative Site 084

Indianapolis, Indiana, United States

Forest Investigative Site 106

Wichita, Kansas, United States

Forest Investigative Site 061

Louisville, Kentucky, United States

Forest Investigative Site 074

Owensboro, Kentucky, United States

Forest Investigative Site 095

Lake Charles, Louisiana, United States

Forest Investigative Site 091

New Orleans, Louisiana, United States

Forest Investigative Site 086

Rockville, Maryland, United States

Forest Investigative Site 059

Newton, Massachusetts, United States

Forest Investigative Site 108

Springfield, Massachusetts, United States

Forest Investigative Site 116

Lincoln, Nebraska, United States

Forest Investigative Site 097

Lincoln, Nebraska, United States

Forest Investigative Site 130

Henderson, Nevada, United States

Forest Investigative Site 104

Las Vegas, Nevada, United States

Forest Investigative Site 136

Neptune City, New Jersey, United States

Forest Investigative Site 127

Toms River, New Jersey, United States

Forest Investigative Site 081

Albuquerque, New Mexico, United States

Forest Investigative Site 107

Albuquerque, New Mexico, United States

Forest Investigative Site 098

The Bronx, New York, United States

Forest Investigative Site 072

Chapel Hill, North Carolina, United States

Forest Investigative Site 069

Avon Lake, Ohio, United States

Forest Investigative Site 001

Columbus, Ohio, United States

Forest Investigative Site 019

Oklahoma City, Oklahoma, United States

Forest Investigative Site 092

Tulsa, Oklahoma, United States

Forest Investigative Site 053

Gresham, Oregon, United States

Forest Investigative Site 132

Johnstown, Pennsylvania, United States

Forest Investigative Site 131

McMurray, Pennsylvania, United States

Forest Investigative Site 100

Media, Pennsylvania, United States

Forest Investigative Site 105

Charleston, South Carolina, United States

Forest Investigative Site 090

Memphis, Tennessee, United States

Forest Investigative Site 057

Nashville, Tennessee, United States

Forest Investigative Site 051

Houston, Texas, United States

Forest Investigative Site 070

The Woodlands, Texas, United States

Forest Investigative Site 028

Clinton, Utah, United States

Forest Investigative Site 141

Ogden, Utah, United States

Forest Investigative Site 029

Salt Lake City, Utah, United States

Forest Investigative Site 064

Charlottesville, Virginia, United States

Forest Investigative Site 113

Norfolk, Virginia, United States

Forest Investigative Site 071

Bothell, Washington, United States

Forest Investigative Site 119

Charleston, West Virginia, United States

Forest Investigative Site 063

Middleton, Wisconsin, United States

Forest Investigative Site 177

Camperdown, New South Wales, Australia

Forest Investigative Site 204

Brussels, , Belgium

Forest Investigative Site 203

Brussels, , Belgium

Forest Investigative Site 202

Hoboken, , Belgium

Forest Investigative Site 201

Leuven, , Belgium

Forest Investigative Site 155

Toronto, Ontario, Canada

Forest Investigative Site 227

Barranquilla, , Colombia

Forest Investigative Site 228

Bello, , Colombia

Forest Investigative Site 226

Bogotá, , Colombia

Forest Investigative Site 276

Tallinn, , Estonia

Forest Investigative Site 329

Bron, Rhone, France

Forest Investigative Site 326

Paris, , France

Forest Investigative Site 379

Budapest, , Hungary

Forest Investigative Site 381

Budapest, , Hungary

Forest Investigative Site 376

Budapest, , Hungary

Forest Investigative Site 378

Budapest, , Hungary

Forest Investigative Site 382

Gyula, , Hungary

Forest Investigative Site 380

Szeged, , Hungary

Forest Investigative Site 401

Kopavogur, , Iceland

Forest Investigative Site 453

Roma, Roma, Italy

Forest Investigative Site 452

Siena, Siena, Italy

Forest Investigative Site 526

Wellington, , New Zealand

Forest Investigative Site 579

Gdansk, , Poland

Forest Investigative Site 578

Gdansk, , Poland

Forest Investigative Site 580

Kielce, , Poland

Forest Investigative Site 576

Kobierzyce, , Poland

Forest Investigative Site 577

Warsaw, , Poland

Forest Investigative Site 626

Belgrade, , Serbia

Forest Investigative Site 627

Belgrade, , Serbia

Forest Investigative Site 629

Niš, , Serbia

Forest Investigative Site 628

Novi Sad, , Serbia

Forest Investigative Site 651

Singapore, , Singapore

Forest Investigative Site 676

Cape Town, Western Cape, South Africa

Forest Investigative Site 704

Yangsan, Gyeongsangnam-do, South Korea

Forest Investigative Site 702

Seoul, , South Korea

Forest Investigative Site 703

Seoul, , South Korea

Forest Investigative Site 701

Seoul, , South Korea

Forest Investigative Site 729

Barcelona, Barcelona, Spain

Forest Investigative Site 728

Sabadell, Barcelona, Spain

Forest Investigative Site 727

Madrid, Madrid, Spain

Forest Investigative Site 730

Torremolinos, Málaga, Spain

Forest Investigative Site 802

Kherson, Vil. Stepanivka, Ukraine

Forest Investigative Site 803

Donetsk, , Ukraine

Forest Investigative Site 807

Kharkiv, , Ukraine

Forest Investigative Site 804

Kyiv, , Ukraine

Forest Investigative Site 801

Odesa, , Ukraine

Countries

United States; Australia; Belgium; Canada; Colombia; Estonia; France; Hungary; Iceland; Italy; New Zealand; Poland; Serbia; Singapore; South Africa; South Korea; Spain; Ukraine

Other Identifiers

MEM-MD-91

Identifier Type: -

Identifier Source: org_study_id