| Primary | Extent of Absorption of Memantine (Part One) | Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter. | Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population) | Posted | | Mean | Standard Deviation | ng•h/mL | | Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose | | | | ID | Title | Description |
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| OG000 | Memantine | Patients received a single dose of 3-mg memantine extended release capsule, oral administration. |
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| Secondary | Core Autism Treatment Scale-Improvement: Total Score | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | At Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Primary | Change in Total Raw Score of Social Responsiveness Scale | 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. | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Core Autism Treatment Scale-Improvement: Social Interaction | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | At Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily, oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Core Autism Treatment Scale-Improvement: Communication | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | At Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily, oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Once daily oral administration of placebo for 12 weeks. | | OG001 | 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. |
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