Trial Outcomes & Findings for A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders (NCT NCT01333865)
NCT ID: NCT01333865
Last Updated: 2024-07-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
Week 12
Results posted on
2024-07-01
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Memantine (Namenda) Treatment
n=19 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.0 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Memantine (Namenda) Treatment
n=18 Participants
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.
|
|---|---|
|
Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)
|
6 participants
|
SECONDARY outcome
Timeframe: Pre-treatment - 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Memantine (Namenda) Treatment
n=18 Participants
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.
|
|---|---|
|
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
|
15 participants
|
Adverse Events
Memantine (Namenda) Treatment
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Memantine (Namenda) Treatment
n=19 participants at risk
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.
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|---|---|
|
General disorders
Sore Throat
|
5.3%
1/19 • Number of events 2 • 3 years
|
|
General disorders
Decreased appetite
|
10.5%
2/19 • Number of events 2 • 3 years
|
|
General disorders
Headache
|
21.1%
4/19 • Number of events 8 • 3 years
|
|
General disorders
Dizziness
|
15.8%
3/19 • Number of events 3 • 3 years
|
|
General disorders
Lower jaw pain
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
PMS symptoms
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
Severe meltdown
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
Depressed mood
|
10.5%
2/19 • Number of events 2 • 3 years
|
|
General disorders
Insomnia
|
21.1%
4/19 • Number of events 5 • 3 years
|
|
General disorders
Nausea
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
Tiredness/sedation
|
36.8%
7/19 • Number of events 7 • 3 years
|
|
General disorders
Back pain
|
10.5%
2/19 • Number of events 2 • 3 years
|
|
General disorders
Dissociated/emotionless
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
Bone pain
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
Common cold/sinus
|
10.5%
2/19 • Number of events 3 • 3 years
|
|
General disorders
Left food pain/tingling
|
10.5%
2/19 • Number of events 2 • 3 years
|
|
General disorders
Kidney stone pain
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
Lighteheaded
|
10.5%
2/19 • Number of events 2 • 3 years
|
|
General disorders
Decreased sex drive
|
5.3%
1/19 • Number of events 3 • 3 years
|
|
General disorders
Dysmenorrhea
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
Burning in urine
|
5.3%
1/19 • Number of events 1 • 3 years
|
|
General disorders
Mispronouncing words
|
5.3%
1/19 • Number of events 1 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place