Trial · NCT00872898
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
NCT00872898, Phase 2, Completed, Forest Laboratories; results first posted 2014-01-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism. Trials, record NCT00872898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00872898
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
- NCT number
- NCT00872898
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Autism
- Interventions
- Memantine - Extended Release (ER), Placebo
- First posted
- 2009-03-31
- Last updated
- 2014-01-14
- Results first posted
- 2014-01-14
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Extent of Absorption of Memantine (Part One) | Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose | Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter. |
| Primary | Change in Total Raw Score of Social Responsiveness Scale | From Baseline to Week 12 | 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. |
| Secondary | Core Autism Treatment Scale-Improvement: Total Score | At Week 12 | 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). |
| Secondary | Core Autism Treatment Scale-Improvement: Social Interaction | At Week 12 | 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). |
| Secondary | Core Autism Treatment Scale-Improvement: Communication | At Week 12 | 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). |
| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale | From Baseline to Week 12 | 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). |
| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale | From Baseline to Week 12 | 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). |
| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale | From Baseline to Week 12 | 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). |
| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale | From Baseline to Week 12 | 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). |
| Secondary | Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale | From Baseline to Week 12 | 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). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Extent of Absorption of Memantine (Part One) | Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose | Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population) | ng•h/mL | MEAN |
| SECONDARY | Core Autism Treatment Scale-Improvement: Total Score | At Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change in Total Raw Score of Social Responsiveness Scale | From Baseline to Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Core Autism Treatment Scale-Improvement: Social Interaction | At Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Core Autism Treatment Scale-Improvement: Communication | At Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale | From Baseline to Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale | From Baseline to Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale | From Baseline to Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale | From Baseline to Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale | From Baseline to Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Extent of Absorption of Memantine (Part One) | Memantine | 682.53 | Standard Deviation 217.77 | ng•h/mL | |
| Core Autism Treatment Scale-Improvement: Total Score | Placebo | 50.4 | Standard Error 1.0 | units on a scale | |
| Core Autism Treatment Scale-Improvement: Total Score | Memantine | 48.3 | Standard Error 1.0 | units on a scale | |
| Change in Total Raw Score of Social Responsiveness Scale | Placebo | -9.5 | Standard Error 2.6 | units on a scale | |
| Change in Total Raw Score of Social Responsiveness Scale | Memantine | -9.6 | Standard Error 2.5 | units on a scale | |
| Core Autism Treatment Scale-Improvement: Social Interaction | Placebo | 32.4 | Standard Error 0.7 | units on a scale | |
| Core Autism Treatment Scale-Improvement: Social Interaction | Memantine | 31.1 | Standard Error 0.6 | units on a scale | |
| Core Autism Treatment Scale-Improvement: Communication | Placebo | 18.0 | Standard Error 0.4 | units on a scale | |
| Core Autism Treatment Scale-Improvement: Communication | Memantine | 17.2 | Standard Error 0.4 | units on a scale | |
| Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale | Placebo | -0.4 | Standard Error 0.5 | units on a scale |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part One - Open Label, Pharmacokinetics | STARTED | Placebo | 0 | |
| Part One - Open Label, Pharmacokinetics | STARTED | Memantine | 4 | |
| Part One - Open Label, Pharmacokinetics | COMPLETED | Placebo | 0 | |
| Part One - Open Label, Pharmacokinetics | COMPLETED | Memantine | 4 | |
| Part One - Open Label, Pharmacokinetics | NOT COMPLETED | Placebo | 0 | |
| Part One - Open Label, Pharmacokinetics | NOT COMPLETED | Memantine | 0 | |
| Part Two - Double Blind | STARTED | Placebo | 61 | |
| Part Two - Double Blind | STARTED | Memantine | 60 | |
| Part Two - Double Blind | COMPLETED | Placebo | 50 | |
| Part Two - Double Blind | COMPLETED | Memantine | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo - Part Two, Double-Blind Treatment | 3 | 61 | |
| other | Headache | Nervous system disorders | Memantine - Part Two, Double-Blind Treatment | 3 | 60 | |
| other | Headache | Nervous system disorders | Memantine - Part One, Open Label Treatment | 1 | 4 | |
| other | Vomiting | Gastrointestinal disorders | Placebo - Part Two, Double-Blind Treatment | 6 | 61 | |
| other | Vomiting | Gastrointestinal disorders | Memantine - Part Two, Double-Blind Treatment | 4 | 60 | |
| other | Vomiting | Gastrointestinal disorders | Memantine - Part One, Open Label Treatment | 0 | 4 | |
| other | Irritability | General disorders | Placebo - Part Two, Double-Blind Treatment | 3 | 61 | |
| other | Irritability | General disorders | Memantine - Part Two, Double-Blind Treatment | 5 | 60 | |
| other | Irritability | General disorders | Memantine - Part One, Open Label Treatment | 0 | 4 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo - Part Two, Double-Blind Treatment | 7 | 61 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Part Two, Double-Blind Treatment | ||
| Total, all-cause mortality | Memantine - Part Two, Double-Blind Treatment | ||
| Total, all-cause mortality | Memantine - Part One, Open Label Treatment | ||
| Total, other adverse events | Placebo - Part Two, Double-Blind Treatment | 31 | 61 |
| Total, other adverse events | Memantine - Part Two, Double-Blind Treatment | 37 | 60 |
| Total, other adverse events | Memantine - Part One, Open Label Treatment | 1 | 4 |
| Total, serious adverse events | Placebo - Part Two, Double-Blind Treatment | 0 | 61 |
| Total, serious adverse events | Memantine - Part Two, Double-Blind Treatment | 1 | 60 |
| Total, serious adverse events | Memantine - Part One, Open Label Treatment | 0 | 4 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00872898
GET https://conductscience.org/api/trials/v1/NCT00872898/results?page=2