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

This study has been terminated.
(Terminated because primary efficacy parameter failed to demonstrate statistically significant difference between memantine and placebo in controlled trials)
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01592773
First received: May 3, 2012
Last updated: January 30, 2015
Last verified: January 2015
Results First Received: January 30, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Autism Spectrum Disorder (ASD)
Autism
Autistic Disorder
Asperger's Disorder
Asperger's
Pediatric Autism
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Intervention: Drug: Memantine Hydrochloride (HCl)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient recruitment occurred over an eleven month period, from October of 2012 to September of 2013, at 106 study sites, located in the United States and 15 other countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Memantine

To maintain the blind of the preceding study, patients who participated in MEM-MD-68 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 the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.


Participant Flow:   Overall Study
    Memantine  
STARTED     747 [1]
COMPLETED     81  
NOT COMPLETED     666  
Study Terminated by Sponsor                 582  
Withdrawal by Subject                 35  
Lost to Follow-up                 19  
Adverse Event                 17  
Lack of Efficacy                 9  
Protocol Violation                 2  
Inclusion/exclusion not meet                 1  
Other Reason                 1  
[1] All enrolled patients received at least 1 dose of investigational product (Safety Population).



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Demographic summaries were provided based on the 747 patients who received at least 1 dose of investigational product in the extension study (Safety Population).

Reporting Groups
  Description
Memantine

To maintain the blind of the preceding study, patients who participated in MEM-MD-68 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 the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.


Baseline Measures
    Memantine  
Number of Participants  
[units: participants]
  747  
Age  
[units: years]
Mean (Standard Deviation)
  9.0  (1.9)  
Gender  
[units: participants]
 
Female     120  
Male     627  
Race/Ethnicity, Customized  
[units: participants]
 
White     636  
Black or African American     42  
Asian     44  
American Indian or Alaska Native     2  
Native Hawaiian or Other Pacific Islander     3  
Other Race     20  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic or Latino     88  
Not Hispanic or Latino     659  
Region of Enrollment  
[units: participants]
 
United States     586  
Belgium     4  
Canada     1  
Colombia     8  
Estonia     5  
France     9  
Hungary     14  
Iceland     5  
Italy     6  
Korea, Republic of     22  
New Zealand     1  
Poland     36  
Serbia     21  
South Africa     1  
Spain     14  
Ukraine     14  



  Outcome Measures

1.  Primary:   Patients With Any Treatment-emergent Adverse Event   [ Time Frame: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Joel Trugman, MD
Organization: Forest Research Institute
phone: 201-427-8681
e-mail: Joel.Trugman@frx.com



Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01592773     History of Changes
Other Study ID Numbers: MEM-MD-69
Study First Received: May 3, 2012
Results First Received: January 30, 2015
Last Updated: January 30, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Public Health Agency of Canada
Colombia: Ministry of Health and Social Protection
Estonia: The State Agency of Medicine
France: Ministry of Health
Hungary: Research Ethics Medical Committee
Iceland: Ministry of Health and Social Security
Italy: Ethics Committee
New Zealand: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Serbia: Medicines and Medical Devices Agency
Singapore: Ministry of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines