A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01333865
First received: November 19, 2010
Last updated: September 30, 2014
Last verified: September 2014
Results First Received: September 15, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Autism Spectrum Disorders
Intervention: Drug: Memantine

  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
Subjects were recruited by local print and Internet advertising. Participants were also recruited from the referral pool of patients in the Pediatric Psychopharmacology Program at the MGH and from the Alan and Lorraine Bressler Clinic and Research Program for ASDs.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Memantine (Namenda) Treatment

Memantine: Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.

During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated.


Participant Flow:   Overall Study
    Memantine (Namenda) Treatment  
STARTED     19 [1]
COMPLETED     17 [2]
NOT COMPLETED     2  
Adverse Event                 2  
[1] 25 participants signed consent, but only 19 completed screening and were analyzed at baseline.
[2] 2 participants were withdrawn. One was still analyzed, but one was withdrawn too early for analysis



  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.
No text entered.

Reporting Groups
  Description
Memantine (Namenda) Treatment

Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.

During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated.


Baseline Measures
    Memantine (Namenda) Treatment  
Number of Participants  
[units: participants]
  19  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     0  
Age  
[units: Years]
Mean ± Standard Deviation
  28.0  ± 9.6  
Gender  
[units: participants]
 
Female     4  
Male     15  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     18  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     19  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     19  



  Outcome Measures
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1.  Primary:   Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)   [ Time Frame: Week 12 ]

2.  Secondary:   Number of Participants With Reduction in ASD Symptom Severity as Defined by the NIMH Clinical Global Impression for Pervasive Developmental Disorders (CGI-PDD) Improvement Score   [ Time Frame: Pre-treatment - 12 weeks ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gagan Joshi, MD
Organization: Massachusetts General Hospital
phone: 617-724-2344
e-mail: joshi.gagan@mgh.harvard.edu


No publications provided


Responsible Party: Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01333865     History of Changes
Other Study ID Numbers: 2010-P-000016
Study First Received: November 19, 2010
Results First Received: September 15, 2014
Last Updated: September 30, 2014
Health Authority: United States: Institutional Review Board