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Trial record 12 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

An Open-Label 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: NCT01592786
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
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 906
Recruitment Details Patient recruitment occurred over an eleven month period, from June of 2012 to May of 2013, at 118 study sites, located in the United States and 17 other countries.
Pre-assignment Details Enrolled patients went through a 2-week screening period.
Arm/Group Title Memantine Hydrochloride (HCl)
Hide Arm/Group Description Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
Period Title: Overall Study
Started 903 [1]
Completed 765
Not Completed 138
Reason Not Completed
Adverse Event             60
Lack of Efficacy             19
Protocol Violation             14
Withdrawal by Subject             23
Lost to Follow-up             19
Other             3
[1]
Participants in the Safety Population are being presented.
Arm/Group Title Memantine Hydrochloride (HCl)
Hide Arm/Group Description Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
Overall Number of Baseline Participants 903
Hide Baseline Analysis Population Description
A total of 906 patients were enrolled in the open-label study. Of these, 903 patients received at least 1 dose of open-label treatment to comprise the Safety Population. 868 patients in the Safety Population also had at least 1 post–Visit 1 assessment of the SRS total raw score to comprise the Intent to Treat (ITT) population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 903 participants
9.0  (1.9)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 903 participants
Male 759
Female 144
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 903 participants
White 768
Black or African American 54
Asian 54
American Indian or Alaska Native 2
Native Hawaiian or Other Pacific Islander 3
Other 22
Hispanic or Latino 102
Not Hispanic or Latino 801
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 903 participants
United States 712
Australia 0
Belgium 11
Canada 1
Colombia 8
Estonia 6
France 14
Hungary 20
Iceland 5
Italy 6
Korea, Republic of 25
New Zealand 2
Poland 37
Serbia 21
Singapore 0
South Africa 2
Spain 17
Ukraine 16
1.Primary Outcome
Title Number of Confirmed Social Responsiveness Scale (SRS) Responders
Hide Description

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.

Time Frame Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 906 patients who enrolled in the study 903 received at least 1 dose of open-label treatment to comprise the Safety Population. The Intent to Treat (ITT) population included the 868 patients in the Safety population who also had at least 1 post–Visit 1 assessment of the SRS total raw score.
Arm/Group Title Memantine Hydrochloride (HCl)
Hide Arm/Group Description:
Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg per day, based upon patient weight.
Overall Number of Participants Analyzed 868
Measure Type: Number
Unit of Measure: participants
Responders 517
Non responders 351
Time Frame Adverse event data was collected over a 14 month period from June 2012 to August 2013 at 118 study sites in the US and 17 other countries.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memantine Hydrochloride (HCl)
Hide Arm/Group Description Memantine Hydrochloride (HCl) extended-release 3-mg capsules, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg, once per day, based upon patient weight.
All-Cause Mortality
Memantine Hydrochloride (HCl)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Memantine Hydrochloride (HCl)
Affected / at Risk (%)
Total   6/903 (0.66%) 
Gastrointestinal disorders   
Constipation  1  1/903 (0.11%) 
Gastroenteritis  1  1/903 (0.11%) 
Injury, poisoning and procedural complications   
Accidental exposure  1  1/903 (0.11%) 
Psychiatric disorders   
Abnormal behaviour  1  2/903 (0.22%) 
Disinhibition  1  1/903 (0.11%) 
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 Hydrochloride (HCl)
Affected / at Risk (%)
Total   196/903 (21.71%) 
General disorders   
Pyrexia  1  52/903 (5.76%) 
Irritability  1  49/903 (5.43%) 
Infections and infestations   
Nasopharyngitis  1  57/903 (6.31%) 
Nervous system disorders   
Headache  1  72/903 (7.97%) 
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 are 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 Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.

Results Point of Contact
Name/Title: Joel Trugman, MD
Organization: Forest Research Institute
Phone: 201-427-8000 ext 8681
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01592786     History of Changes
Other Study ID Numbers: MEM-MD-91
First Submitted: May 3, 2012
First Posted: May 7, 2012
Results First Submitted: July 15, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014