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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT01592773

First received: May 3, 2012

Last updated: May 3, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 3, 2012

Last Updated Date

May 3, 2013

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Adverse event (AE) recording, clinical laboratory measures, vital signs parameters, electrocardiograms (ECGs), cognitive testing, suicidality, and physical examinations

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01592773 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label Extension 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)

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).

Detailed Description

This clinical study will be a 48-week, multicenter, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at approximately 180 study centers. Patients may be eligible for this long-term extension study if they have:

completed the open-label Study MEM MD 67,
completed the open-label Study MEM-MD-91,
completed the double-blind study MEM-MD-68,
discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Memantine Hydrochloride (HCl)

During double-blind treatment Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing will be once daily.

During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage will be that identified during the prior studies for each patient. Dosing will be once daily.

Other Name: Namenda

Study Arm (s)

Experimental: Memantine

To maintain the blind of the preceding study, patients who participated in MEM-MD-68 will begin this study with 6 weeks of double blind dosing during which all patients will either be titrated to or remain on their maximum target dosages. Patients who have had a break of > 3days since last treatment will be titrated. This will be followed by 42 weeks of open-label dosing.

Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM MD 91, will receive 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.

Intervention: Drug: Memantine Hydrochloride (HCl)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

220

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients who completed Study MEM-MD-67, MEM-MD-68 or MEM-MD-91.
Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.

Exclusion Criteria:

Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug

Gender

Both

Ages

6 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Colombia, Estonia, Hungary, Iceland, Italy, Korea, Republic of, New Zealand, Poland, Serbia, South Africa, Spain, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01592773

Other Study ID Numbers ^ICMJE

MEM-MD-69

Has Data Monitoring Committee

Responsible Party

Forest Laboratories

Study Sponsor ^ICMJE

Forest Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jordan Lateiner, MS, MBA

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

Information Provided By

Forest Laboratories

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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