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Trial record 18 of 87 for:    Developmental Disabilities | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01592773
Recruitment Status : Terminated (Terminated because primary efficacy parameter failed to demonstrate statistically significant difference between memantine and placebo in controlled trials)
First Posted : May 7, 2012
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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)
Enrollment 747
Recruitment Details 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  
Arm/Group Title Memantine
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 747 [1]
Completed 81
Not Completed 666
Reason Not Completed
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).
Arm/Group Title Memantine
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 747
Hide Baseline Analysis Population Description
Demographic summaries were provided based on the 747 patients who received at least 1 dose of investigational product in the extension study (Safety Population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 747 participants
9.0  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 747 participants
Female
120
  16.1%
Male
627
  83.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 747 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 747 participants
Hispanic or Latino 88
Not Hispanic or Latino 659
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 747 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
1.Primary Outcome
Title Patients With Any Treatment-emergent Adverse Event
Hide Description Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Time Frame Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the 747 patients who took at least 1 dose of investigational product (Safety Population).
Arm/Group Title Memantine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 747
Measure Type: Number
Unit of Measure: participants
424
Time Frame Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Adverse Event Reporting Description Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
 
Arm/Group Title Memantine
Hide Arm/Group Description

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.

All-Cause Mortality
Memantine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Memantine
Affected / at Risk (%)
Total   8/747 (1.07%) 
Gastrointestinal disorders   
Abdominal pain  1  1/747 (0.13%) 
Abdominal pain lower  1  1/747 (0.13%) 
Vomiting  1  1/747 (0.13%) 
Infections and infestations   
Appendicitis  1  1/747 (0.13%) 
Injury, poisoning and procedural complications   
Foreign body  1  1/747 (0.13%) 
Rectal prolapse  1  1/747 (0.13%) 
Investigations   
Dehydration  1  1/747 (0.13%) 
Nervous system disorders   
Abnormal behaviour  1  1/747 (0.13%) 
Dysphoria  1  1/747 (0.13%) 
Homicidal ideation  1  1/747 (0.13%) 
Suicidal ideation  1  1/747 (0.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Memantine
Affected / at Risk (%)
Total   150/747 (20.08%) 
Gastrointestinal disorders   
Vomiting  1  51/747 (6.83%) 
General disorders   
Pyrexia  1  47/747 (6.29%) 
Infections and infestations   
Nasopharyngitis  1  55/747 (7.36%) 
Nervous system disorders   
Headache  1  41/747 (5.49%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.

All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.

Publication of the results by the PI will be subject to mutual agreement between the PI and Forest Research Institute, Inc.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joel Trugman, MD
Organization: Forest Research Institute
Phone: 201-427-8681
EMail: Joel.Trugman@frx.com
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01592773     History of Changes
Other Study ID Numbers: MEM-MD-69
First Submitted: May 3, 2012
First Posted: May 7, 2012
Results First Submitted: January 30, 2015
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015