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Autism Spectrum Disorder (ASD)Phase 2NCT01592786

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

A Phase 2 study testing Memantine Hydrochloride (HCl) in people with Autism Spectrum Disorder (ASD) and Autism, run by Forest Laboratories at 118 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
Memantine Hydrochloride (HCl)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
906 participants
Where
118 sitesin 18 countries
Study dates
Jun 2012to Aug 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female outpatients.
  • Age of 6-12.
  • 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)
  • 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

Who cannot join

  • Have enrolled in Study MEM-MD-57A
  • Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being.
  • Participation in any other clinical investigation using an experimental drug within 30 days of screening.
  • Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS.
  • 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

Trial locations and contacts

118 sites in 18 countries.

118 sites in 18 countries

United States72 sites

  • Forest Investigative Site 081

    Albuquerque, New Mexico, 87108-5129

  • Forest Investigative Site 107

    Albuquerque, New Mexico, 87109

  • Forest Investigative Site 069

    Avon Lake, Ohio, 44012

  • Forest Investigative Site 071

    Bothell, Washington, 98011

  • Forest Investigative Site 078

    Boulder, Colorado, 80304

  • Forest Investigative Site 075

    Bradenton, Florida, 32751

  • Forest Investigative Site 073

    Centennial, Colorado, 80112

  • Forest Investigative Site 072

    Chapel Hill, North Carolina, 27514

  • Forest Investigative Site 105

    Charleston, South Carolina, 29407

  • Forest Investigative Site 119

    Charleston, West Virginia, 25304

  • Forest Investigative Site 064

    Charlottesville, Virginia, 22903

  • Forest Investigative Site 028

    Clinton, Utah, 84015

  • Forest Investigative Site 001

    Columbus, Ohio, 43210

  • Forest Investigative Site 068

    Dothan, Alabama, 36303

  • Forest Investigative Site 082

    Evansville, Indiana, 47713

  • Forest Investigative Site 123

    Fort Wayne, Indiana, 46805

  • Forest Investigative Site 080

    Gainesville, Florida, 32607

  • Forest Investigative Site 054

    Glendale, California, 91206

  • Forest Investigative Site 053

    Gresham, Oregon, 97030

  • Forest Investigative Site 130

    Henderson, Nevada, 89052

  • Forest Investigative Site 051

    Houston, Texas, 77090

  • Forest Investigative Site 109

    Imperial, California, 92251

  • Forest Investigative Site 056

    Indianapolis, Indiana, 46260

  • Forest Investigative Site 084

    Indianapolis, Indiana, 46260

  • Forest Investigative Site 066

    Irvine, California, 92612

  • Forest Investigative Site 117

    Jacksonville, Florida, 32216

  • Forest Investigative Site 132

    Johnstown, Pennsylvania, 15904

  • Forest Investigative Site 095

    Lake Charles, Louisiana, 70605

  • Forest Investigative Site 104

    Las Vegas, Nevada, 89128

  • Forest Investigative Site 102

    Libertyville, Illinois, 60048

  • Forest Investigative Site 116

    Lincoln, Nebraska, 68516

  • Forest Investigative Site 097

    Lincoln, Nebraska, 68526

  • Forest Investigative Site 077

    Little Rock, Arkansas, 72202-3591

  • Forest Investigative Site 096

    Los Angeles, California, 90024

  • Forest Investigative Site 061

    Louisville, Kentucky, 40202

  • Forest Investigative Site 065

    Maitland, Florida, 32751

  • Forest Investigative Site 131

    McMurray, Pennsylvania, 15317

  • Forest Investigative Site 100

    Media, Pennsylvania, 19063

  • Forest Investigative Site 090

    Memphis, Tennessee, 38119

  • Forest Investigative Site 118

    Miami, Florida, 33155

  • Forest Investigative Site 063

    Middleton, Wisconsin, 53562

  • Forest Investigative Site 023

    Naperville, Illinois, 60563

  • Forest Investigative Site 057

    Nashville, Tennessee, 37232

  • Forest Investigative Site 136

    Neptune City, New Jersey, 07753

  • Forest Investigative Site 091

    New Orleans, Louisiana, 70112

  • Forest Investigative Site 059

    Newton, Massachusetts, 02459

  • Forest Investigative Site 113

    Norfolk, Virginia, 23507

  • Forest Investigative Site 085

    Oakland Park, Florida, 33334

  • Forest Investigative Site 141

    Ogden, Utah, 84405

  • Forest Investigative Site 019

    Oklahoma City, Oklahoma, 73116

  • Forest Investigative Site 115

    Orange City, Florida, 32763

  • Forest Investigative Site 124

    Orlando, Florida, 32803

  • Forest Investigative Site 125

    Orlando, Florida, 32803

  • Forest Investigative Site 062

    Orlando, Florida, 32806

  • Forest Investigative Site 114

    Orlando, Florida, 32839

  • Forest Investigative Site 074

    Owensboro, Kentucky, 42301

  • Forest Investigative Site 005

    Phoenix, Arizona, 85006

  • Forest Investigative Site 086

    Rockville, Maryland, 20852

  • Forest Investigative Site 029

    Salt Lake City, Utah, 84106

  • Forest Investigative Site 021

    San Francisco, California, 94143-0984

  • Forest Investigative Site 026

    Santa Ana, California, 92701

  • Forest Investigative Site 108

    Springfield, Massachusetts, 01199

  • Forest Investigative Site 002

    Stanford, California, 94305-5719

  • Forest Investigative Site 067

    Tampa, Florida, 33612

  • Forest Investigative Site 098

    The Bronx, New York, 10467

  • Forest Investigative Site 070

    The Woodlands, Texas, 77381

  • Forest Investigative Site 127

    Toms River, New Jersey, 08755

  • Forest Investigative Site 055

    Tucson, Arizona, 85718

  • Forest Investigative Site 092

    Tulsa, Oklahoma, 74104

  • Forest Investigative Site 052

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

  • Forest Investigative Site 101

    Wellington, Florida, 33414

  • Forest Investigative Site 106

    Wichita, Kansas, 67214-3199

Other trials in United States

Hungary6 sites

  • Forest Investigative Site 379

    Budapest, 1021

  • Forest Investigative Site 381

    Budapest, 1026

  • Forest Investigative Site 376

    Budapest, 1083

  • Forest Investigative Site 378

    Budapest, 1089

  • Forest Investigative Site 382

    Gyula, 5700

  • Forest Investigative Site 380

    Szeged, 6725

Other trials in Hungary

Poland5 sites

  • Forest Investigative Site 579

    Gdansk, 80-542

  • Forest Investigative Site 578

    Gdansk, 80-952

  • Forest Investigative Site 580

    Kielce, 25-317

  • Forest Investigative Site 576

    Kobierzyce, 55-040

  • Forest Investigative Site 577

    Warsaw, 02-957

Other trials in Poland

Ukraine5 sites

  • Forest Investigative Site 803

    Donetsk, 83008

  • Forest Investigative Site 807

    Kharkiv, 61153

  • Forest Investigative Site 802

    Kherson, Vil. Stepanivka, 73488

  • Forest Investigative Site 804

    Kyiv, 4080

  • Forest Investigative Site 801

    Odesa, 65014

Other trials in Ukraine

Belgium4 sites

  • Forest Investigative Site 204

    Brussels, 1020

  • Forest Investigative Site 203

    Brussels, 1090

  • Forest Investigative Site 202

    Hoboken, 2660

  • Forest Investigative Site 201

    Leuven, 3000

Other trials in Belgium

Serbia4 sites

  • Forest Investigative Site 626

    Belgrade, 11000

  • Forest Investigative Site 627

    Belgrade, 11000

  • Forest Investigative Site 629

    Niš, 18000

  • Forest Investigative Site 628

    Novi Sad, 21000

Other trials in Serbia

South Korea4 sites

  • Forest Investigative Site 702

    Seoul, 110744

  • Forest Investigative Site 703

    Seoul, 120-752

  • Forest Investigative Site 701

    Seoul, 138-736

  • Forest Investigative Site 704

    Yangsan, Gyeongsangnam-do, 626-770

Other trials in South Korea

Spain4 sites

  • Forest Investigative Site 729

    Barcelona, Barcelona, 8221

  • Forest Investigative Site 727

    Madrid, Madrid, 28031

  • Forest Investigative Site 728

    Sabadell, Barcelona, 8208

  • Forest Investigative Site 730

    Torremolinos, Málaga, 29620

Other trials in Spain

Colombia3 sites

  • Forest Investigative Site 227

    Barranquilla

  • Forest Investigative Site 228

    Bello

  • Forest Investigative Site 226

    Bogotá

Other trials in Colombia

France2 sites

  • Forest Investigative Site 329

    Bron, Rhone, 69500

  • Forest Investigative Site 326

    Paris, 75935

Other trials in France

Italy2 sites

  • Forest Investigative Site 453

    Roma, Roma, 165

  • Forest Investigative Site 452

    Siena, Siena, 53100

Other trials in Italy

Australia1 site

  • Forest Investigative Site 177

    Camperdown, New South Wales, 2050

Other trials in Australia

Canada1 site

  • Forest Investigative Site 155

    Toronto, Ontario, M5B 1T8

Other trials in Canada

Estonia1 site

  • Forest Investigative Site 276

    Tallinn, 10617

Other trials in Estonia

Iceland1 site

  • Forest Investigative Site 401

    Kopavogur, 200

Other trials in Iceland

New Zealand1 site

  • Forest Investigative Site 526

    Wellington, 6012

Other trials in New Zealand

Singapore1 site

  • Forest Investigative Site 651

    Singapore, 539747

Other trials in Singapore

South Africa1 site

  • Forest Investigative Site 676

    Cape Town, Western Cape, 7530

Other trials in South Africa

About this study

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

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.

Read the 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
Being tested
Memantine Hydrochloride (HCl)
Keywords
Autism Spectrum Disorder (ASD), Autism, Autistic Disorder, Asperger's Disorder, Asperger's, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Memantine, Pediatric Disorder
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Memantine Hydrochloride (HCl)Drug

    Also called Namenda

    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.

Study groups in NCT01592786
Study groupRoleWhat they receive
Memantine Hydrochloride (HCl)ExperimentalOnce 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.
Receives: Drug: Memantine Hydrochloride (HCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Confirmed Social Responsiveness Scale (SRS) Responders

    A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks.

    The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment.

    Measured: Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJul 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
906 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01592786
Sponsor's protocol ID
MEM-MD-91
Status last verified
Jul 2014
First submitted
3 May 2012
Last updated
7 Aug 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Memantine Hydrochloride (HCl) in people with Autism Spectrum Disorder (ASD) and Autism, run by Forest Laboratories at 118 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Hungary, Poland, Ukraine, Belgium and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Confirmed Social Responsiveness Scale (SRS) Responders (time frame: Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01592786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.

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