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

NCT01592773 | Terminated Phase 2 Results

• 1 other identifier: MEM-MD-69
• Study Type: interventional
• Target: 747
• Locations: 15 countries
• Sites: 105

Brief Summary

The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patients With Any Treatment-emergent Adverse Event

  Number of patients who experienced 1 or more Treatment Emergent Adverse Event

  Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit

Study Arms (1)

Memantine

EXPERIMENTAL

To maintain the blind of the preceding study, patients who participated in MEM-MD-68 (NCT01592747) began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing. Patients who took open-label memantine in study MEM-MD-67 (NCT01999894) or MEM-MD-91(NCT01592786), received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.

Drug: Memantine Hydrochloride (HCl)

Interventions

Memantine Hydrochloride (HCl) DRUG

During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily. During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.

Also known as: Namenda

Memantine

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
• Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
• 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

You may not qualify if:

• Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
• Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
• Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (106)

Forest Investigative Site 068

Dothan, Alabama, 36303, United States

Location

Forest Investigative Site 005

Phoenix, Arizona, 85006, United States

Location

Forest Investigative Site 055

Tucson, Arizona, 85718, United States

Location

Forest Investigative Site 077

Little Rock, Arkansas, 72202-3591, United States

Location

Forest Investigative Site 054

Glendale, California, 91206, United States

Location

Forest Investigative Site 109

Imperial, California, 92251, United States

Location

Forest Investigative Site 066

Irvine, California, 92612, United States

Location

Forest Investigative Site 096

Los Angeles, California, 90024, United States

Location

Forest Investigative Site 021

San Francisco, California, 94143-0984, United States

Location

Forest Investigative Site 026

Santa Ana, California, 92701, United States

Location

Forest Investigative Site 002

Stanford, California, 94305-5719, United States

Location

Forest Investigative Site 078

Boulder, Colorado, 80304, United States

Location

Forest Investigative Site 073

Centennial, Colorado, 80112, United States

Location

Forest Investigative Site 052

Washington D.C., District of Columbia, 20010-2970, United States

Location

Forest Investigative Site 075

Bradenton, Florida, 32751, United States

Location

Forest Investigative Site 080

Gainesville, Florida, 32607, United States

Location

Forest Investigative Site 117

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 065

Maitland, Florida, 32751, United States

Location

Forest Investigative Site 118

Miami, Florida, 33155, United States

Location

Forest Investigative Site 085

Oakland Park, Florida, 33334, United States

Location

Forest Investigative Site 115

Orange City, Florida, 32763, United States

Location

Forest Investigative Site 125

Orlando, Florida, 32803, United States

Location

Forest Investigative Site 062

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 067

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 101

Wellington, Florida, 33414, United States

Location

Forest Investigative Site 102

Libertyville, Illinois, 60048, United States

Location

Forest Investigative Site 023

Naperville, Illinois, 60563, United States

Location

Forest Investigative Site 082

Evansville, Indiana, 47713, United States

Location

Forest Investigative Site 123

Fort Wayne, Indiana, 46805, United States

Location

Forest Investigative Site 056

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 061

Louisville, Kentucky, 40202, United States

Location

Forest Investigative Site 095

Lake Charles, Louisiana, 70605, United States

Location

Forest Investigative Site 091

New Orleans, Louisiana, 70112, United States

Location

Forest Investigative Site 086

Rockville, Maryland, 20852, United States

Location

Forest Investigative Site 059

Newton, Massachusetts, 02459, United States

Location

Forest Investigative Site 108

Springfield, Massachusetts, 01199, United States

Location

Forest Investigative Site 116

Lincoln, Nebraska, 68516, United States

Location

Forest Investigative Site 097

Lincoln, Nebraska, 68526, United States

Location

Forest Investigative Site 130

Henderson, Nevada, 89052, United States

Location

Forest Investigative Site 104

Las Vegas, Nevada, 89128, United States

Location

Forest Investigative Site 136

Neptune City, New Jersey, 07753, United States

Location

Forest Investigative Site 127

Toms River, New Jersey, 08755, United States

Location

Forest Investigative Site 081

Albuquerque, New Mexico, 87108-5129, United States

Location

Forest Investigative Site 107

Albuquerque, New Mexico, 87109, United States

Location

Forest Investigative Site 098

The Bronx, New York, 10467, United States

Location

Forest Investigative Site 072

Chapel Hill, North Carolina, 27514, United States

Location

Forest Investigative Site 069

Avon Lake, Ohio, 44012, United States

Location

Forest Investigative Site 001

Columbus, Ohio, 43210, United States

Location

Forest Investigative Site 019

Oklahoma City, Oklahoma, 73116, United States

Location

Forest Investigative Site 092

Tulsa, Oklahoma, 74104, United States

Location

Forest Investigative Site 053

Gresham, Oregon, 97030, United States

Location

Forest Investigative Site 132

Johnstown, Pennsylvania, 15904, United States

Location

Forest Investigative Site 131

McMurray, Pennsylvania, 15317, United States

Location

Forest Investigative Site 100

Media, Pennsylvania, 19063, United States

Location

Forest Investigative Site 105

Charleston, South Carolina, 29407, United States

Location

Forest Investigative Site 090

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 057

Nashville, Tennessee, 37232, United States

Location

Forest Investigative Site 051

Houston, Texas, 77090, United States

Location

Forest Investigative Site 070

The Woodlands, Texas, 77381, United States

Location

Forest Investigative Site 028

Clinton, Utah, 84015, United States

Location

Forest Investigative Site 141

Ogden, Utah, 84405, United States

Location

Forest Investigative Site 029

Salt Lake City, Utah, 84106, United States

Location

Forest Investigative Site 064

Charlottesville, Virginia, 22903, United States

Location

Forest Investigative Site 113

Norfolk, Virginia, 23507, United States

Location

Forest Investigative Site 124

Roanoke, Virginia, 24014, United States

Location

Forest Investigative Site 071

Bothell, Washington, 98011, United States

Location

Forest Investigative Site 119

Charleston, West Virginia, 25304, United States

Location

Forest Investigative Site 063

Middleton, Wisconsin, 53562, United States

Location

Forest Investigative Site 204

Brussels, 1020, Belgium

Location

Forest Investigative Site 203

Jette, 1090, Belgium

Location

Forest Investigative Site 155

Toronto, Ontario, M5B 1T8, Canada

Location

Forest Investigative Site 228

Antioquia, Bello, Colombia

Location

Forest Investigative Site 227

Barranquilla, 84176, Colombia

Location

Forest Investigative Site 226

Bogotá, Colombia

Location

Forest Investigative Site 276

Tallinn, 10617, Estonia

Location

Forest Investigative Site 329

Bron, Rhone, 69500, France

Location

Forest Investigative Site 381

Budapest, 1026, Hungary

Location

Forest Investigative Site 376

Budapest, 1083, Hungary

Location

Forest Investigative Site 378

Budapest, 1089, Hungary

Location

Forest Investigative Site 382

Gyula, 5700, Hungary

Location

Forest Investigative Site 401

Kopavogur, 200, Iceland

Location

Forest Investigative Site 453

Roma, 00165, Italy

Location

Forest Investigative Site 452

Siena, 53100, Italy

Location

Forest Investigative Site 526

Wellington, 7902, New Zealand

Location

Forest Investigative Site 579

Gdansk, 80542, Poland

Location

Forest Investigative Site 578

Gdansk, 80952, Poland

Location

Forest Investigative Site 580

Kielce, 25317, Poland

Location

Forest Investigative Site 576

Tyniec Mały, 55040, Poland

Location

Forest Investigative Site 577

Warsaw, 80214, Poland

Location

Forest Investigative Site 626

Belgrade, 11000, Serbia

Location

Forest Investigative Site 627

Belgrade, 11000, Serbia

Location

Forest Investigative Site 629

Niš, 18000, Serbia

Location

Forest Investigative Site 628

Novi Sad, 21000, Serbia

Location

Forest Investigative Site 676

Bellville Cape Town, 7530, South Africa

Location

Forest Investigative Site 704

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

Forest Investigative Site 702

Seoul, 110744, South Korea

Location

Forest Investigative Site 703

Seoul, 120752, South Korea

Location

Forest Investigative Site 701

Seoul, 138736, South Korea

Location

Forest Investigative Site 729

Barcelona, 08221, Spain

Location

Forest Investigative Site 728

Sabadell, 08208, Spain

Location

Forest Investigative Site 730

Torremolinos, 29620, Spain

Location

Forest Investigative Site 803

Donetsk, 83008, Ukraine

Location

Forest Investigative Site 807

Kharkiv, 61153, Ukraine

Location

Forest Investigative Site 802

Kherson, 73488, Ukraine

Location

Forest Investigative Site 804

Kyiv, 4080, Ukraine

Location

Forest Investigative Site 801

Odesa, 65014, Ukraine

Location

Related Publications (1)

• 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: 36006807 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome

Interventions

Memantine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Joel Trugman, MD
• Organization: Forest Research Institute

Joel.Trugman@frx.com

201-427-8681

Study Officials

• Jordan Lateiner, MS, MBA

  Forest Research Institute, Inc.- 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 16, 2015
• Results First Posted: February 16, 2015

Record last verified: 2015-01

Locations

ES (3); NZ (1); US (68); UA (5); CA (1); FR (1); BE (2); IC (1); KR (4); PL (5); HU (4); CO (3); IT (2); SE (4); ZA (1)