Trial Outcomes & Findings for Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism (NCT NCT00872898)
NCT ID: NCT00872898
Last Updated: 2014-01-14
Results Overview
Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.
COMPLETED
PHASE2
124 participants
Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose
2014-01-14
Participant Flow
Patients for Part One of the study were recruited during a 15 month period from April of 2009, to June of 2010. Patients for Part Two of the study were recruited for a 37 month period from April of 2009 to April of 2012. All study sites were located in the United States.
Part One of the study enrolled 4 patients to determine a safe dosing regimen for Part Two. One patient from Part One of the study also enrolled in Part Two. The 121 patients enrolled in Part Two were randomized after two weeks of single-blind placebo treatment.
Participant milestones
| Measure |
Placebo
Once daily, oral administration of placebo for 12 weeks.
|
Memantine
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Part One - Open Label, Pharmacokinetics
STARTED
|
0
|
4
|
|
Part One - Open Label, Pharmacokinetics
COMPLETED
|
0
|
4
|
|
Part One - Open Label, Pharmacokinetics
NOT COMPLETED
|
0
|
0
|
|
Part Two - Double Blind
STARTED
|
61
|
60
|
|
Part Two - Double Blind
COMPLETED
|
50
|
54
|
|
Part Two - Double Blind
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Once daily, oral administration of placebo for 12 weeks.
|
Memantine
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Part Two - Double Blind
Adverse Event
|
4
|
3
|
|
Part Two - Double Blind
Lack of Efficacy
|
1
|
0
|
|
Part Two - Double Blind
Protocol Violation
|
1
|
0
|
|
Part Two - Double Blind
Withdrawal by Subject
|
3
|
1
|
|
Part Two - Double Blind
Lost to Follow-up
|
0
|
2
|
|
Part Two - Double Blind
Other reasons
|
2
|
0
|
Baseline Characteristics
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
Baseline characteristics by cohort
| Measure |
Part One - Memantine
n=3 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Part Two - Placebo
n=61 Participants
Once daily oral administration of placebo for 12 weeks.
|
Part Two - Memantine
n=60 Participants
Once daily oral administration of memantine extended release for 12 weeks. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
6 years to 18 years
|
9.0 years
STANDARD_DEVIATION 2.6 • n=93 Participants
|
8.9 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
9.0 years
STANDARD_DEVIATION 2.2 • n=27 Participants
|
9.0 years
STANDARD_DEVIATION 0.1 • n=483 Participants
|
|
Age, Customized
6 years to 12 years
|
3 participants
n=93 Participants
|
60 participants
n=4 Participants
|
59 participants
n=27 Participants
|
122 participants
n=483 Participants
|
|
Age, Customized
13 years to 18 years
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
102 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
61 participants
n=4 Participants
|
60 participants
n=27 Participants
|
124 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dosePopulation: Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population)
Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.
Outcome measures
| Measure |
Memantine
n=4 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Extent of Absorption of Memantine (Part One)
|
682.53 ng•h/mL
Standard Deviation 217.77
|
—
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, ranging from 0 (no impairment) to 195 (severe social impairment). Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment.
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Total Raw Score of Social Responsiveness Scale
|
-9.5 units on a scale
Standard Error 2.6
|
-9.6 units on a scale
Standard Error 2.5
|
SECONDARY outcome
Timeframe: At Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Core Autism Treatment Scale-Improvement (CATS-I) is based on rating 14 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 14 (improved) to 98 (worsened). The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Core Autism Treatment Scale-Improvement: Total Score
|
50.4 units on a scale
Standard Error 1.0
|
48.3 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: At Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Core Autism Treatment Scale-Improvement (CATS-I) Social Interaction Subscale is based on rating 9 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 9 (improved) to 63 (worsened). The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Core Autism Treatment Scale-Improvement: Social Interaction
|
32.4 units on a scale
Standard Error 0.7
|
31.1 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: At Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Core Autism Treatment Scale-Improvement (CATS-I) Communication Subscale is based on rating 5 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 5 (improved) to 35 (worsened). The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Core Autism Treatment Scale-Improvement: Communication
|
18.0 units on a scale
Standard Error 0.4
|
17.2 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Speech Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale
|
-0.4 units on a scale
Standard Error 0.5
|
-0.7 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Syntax Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale
|
-1.1 units on a scale
Standard Error 0.4
|
-1.2 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Semantics Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale
|
-0.2 units on a scale
Standard Error 0.3
|
-0.5 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Coherence Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale
|
-1.2 units on a scale
Standard Error 0.5
|
-1.2 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Initiation Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale
|
-0.8 units on a scale
Standard Error 0.5
|
-0.9 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Scripted Language Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale
|
-1.0 units on a scale
Standard Error 0.4
|
-0.5 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Context Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale
|
-1.5 units on a scale
Standard Error 0.4
|
-0.2 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Nonverbal Communication Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale
|
-0.7 units on a scale
Standard Error 0.4
|
-0.9 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Social Relations Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale
|
-1.0 units on a scale
Standard Error 0.4
|
-0.8 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
The Children's Communication Checklist-2 (CCC-2) Interests Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times \[more than twice\] a day or always), with a total raw score of 0 (mildest) to 21 (most severe). The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Outcome measures
| Measure |
Memantine
n=53 Participants
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
Memantine
n=54 Participants
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
|
|---|---|---|
|
Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale
|
-0.5 units on a scale
Standard Error 0.4
|
-0.5 units on a scale
Standard Error 0.4
|
Adverse Events
Placebo - Part Two, Double-Blind Treatment
Memantine - Part Two, Double-Blind Treatment
Memantine - Part One, Open Label Treatment
Serious adverse events
| Measure |
Placebo - Part Two, Double-Blind Treatment
n=61 participants at risk
Once daily oral administration of placebo for 12 weeks
|
Memantine - Part Two, Double-Blind Treatment
n=60 participants at risk
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.
|
Memantine - Part One, Open Label Treatment
n=4 participants at risk
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
|---|---|---|---|
|
Psychiatric disorders
Affective Disorder
|
0.00%
0/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
1.7%
1/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
Other adverse events
| Measure |
Placebo - Part Two, Double-Blind Treatment
n=61 participants at risk
Once daily oral administration of placebo for 12 weeks
|
Memantine - Part Two, Double-Blind Treatment
n=60 participants at risk
Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.
|
Memantine - Part One, Open Label Treatment
n=4 participants at risk
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
4.9%
3/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
5.0%
3/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
25.0%
1/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
6/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
6.7%
4/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
General disorders
Irritability
|
4.9%
3/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
8.3%
5/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
7/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
10.0%
6/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Infections and infestations
Influenza
|
3.3%
2/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
6.7%
4/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
6.6%
4/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
1.7%
1/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Psychiatric disorders
Aggression
|
4.9%
3/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
8.3%
5/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Psychiatric disorders
Agitation
|
1.6%
1/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
6.7%
4/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Psychiatric disorders
Insomnia
|
4.9%
3/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
6.7%
4/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
3/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
10.0%
6/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
5.0%
3/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.2%
5/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
1.7%
1/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Nervous system disorders
Anxiety
|
6.6%
4/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
6/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
3.3%
2/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
|
General disorders
Pyrexia
|
6.6%
4/61 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
3.3%
2/60 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
0.00%
0/4 • Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
|
Additional Information
Ephraim Katz, PhD / Associate Director
Forest Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study are the property of Forest Research Institute. 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.
- Publication restrictions are in place
Restriction type: OTHER