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

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ClinicalTrials.gov Identifier: NCT01333865
Recruitment Status : Completed
First Posted : April 12, 2011
Results First Posted : October 6, 2014
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autism Spectrum Disorders
Intervention Drug: Memantine
Enrollment 25
Recruitment Details 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  
Arm/Group Title Memantine (Namenda) Treatment
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 19 [1]
Completed 17 [2]
Not Completed 2
Reason Not Completed
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2 participants were withdrawn. One was still analyzed, but one was withdrawn too early for analysis
Arm/Group Title Memantine (Namenda) Treatment
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
28.0  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
4
  21.1%
Male
15
  78.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Hispanic or Latino
1
   5.3%
Not Hispanic or Latino
18
  94.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
19
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)
Hide Description

Number of participants with reduction in ASD symptom severity defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30%.

The SRS is a 65-item rating scale completed by an informant to measure the severity of autism spectrum symptoms as they occur in natural settings.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.
Arm/Group Title Memantine (Namenda) Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
6
2.Secondary Outcome
Title 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
Hide Description Number of participants with reduction in ASD symptom severity defined as an NIMH Clinical Global Impression (CGI) Pervasive Developmental Disorder (PDD) Improvement score less than or equal to 2. The CGI-Improvement is a clinician-rated measure of improvement. Scores range from 1 (very much improved) to 7 (very much worse) for PDD.
Time Frame Pre-treatment - 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.
Arm/Group Title Memantine (Namenda) Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
15
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memantine (Namenda) Treatment
Hide Arm/Group Description

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 be 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.

All-Cause Mortality
Memantine (Namenda) Treatment
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Memantine (Namenda) Treatment
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Memantine (Namenda) Treatment
Affected / at Risk (%) # Events
Total   14/19 (73.68%)    
General disorders   
Sore Throat  1/19 (5.26%)  2
Decreased appetite  2/19 (10.53%)  2
Headache  4/19 (21.05%)  8
Dizziness  3/19 (15.79%)  3
Lower jaw pain  1/19 (5.26%)  1
PMS symptoms  1/19 (5.26%)  1
Severe meltdown  1/19 (5.26%)  1
Depressed mood  2/19 (10.53%)  2
Insomnia  4/19 (21.05%)  5
Nausea  1/19 (5.26%)  1
Tiredness/sedation  7/19 (36.84%)  7
Back pain  2/19 (10.53%)  2
Dissociated/emotionless  1/19 (5.26%)  1
Bone pain  1/19 (5.26%)  1
Common cold/sinus  2/19 (10.53%)  3
Left food pain/tingling  2/19 (10.53%)  2
Kidney stone pain  1/19 (5.26%)  1
Lighteheaded  2/19 (10.53%)  2
Decreased sex drive  1/19 (5.26%)  3
Dysmenorrhea  1/19 (5.26%)  1
Burning in urine  1/19 (5.26%)  1
Mispronouncing words  1/19 (5.26%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gagan Joshi, MD
Organization: Massachusetts General Hospital
Phone: 617-724-2344
EMail: joshi.gagan@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01333865    
Other Study ID Numbers: 2010-P-000016
First Submitted: November 19, 2010
First Posted: April 12, 2011
Results First Submitted: September 15, 2014
Results First Posted: October 6, 2014
Last Update Posted: March 24, 2016