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Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine

Primary Purpose

Autistic Disorder, Autism, Asperger's Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Memantine Hydrochloride (HCl)
Memantine Hydrochloride (HCl)
Placebo capsules
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Asperger's, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Memantine, Pediatric Disorder, Randomized Controlled Trial

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 (NCT01592786)
  2. Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91
  3. Provide written informed assent, when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. The parent/guardian/LAR must provide written informed consent before the patient's participation in the study. A separate written informed consent for the caregiver must also be obtained before the conduct of any study specific procedures
  4. Have a knowledgeable caregiver who is capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug. Every effort should be made to maintain the same caregiver as used in the lead-in study throughout this study
  5. Have normal results from the physical examination, laboratory tests, ECG, and vital signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings must be deemed not clinically significant by the Investigator and documented
  6. Be able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR who is able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), to comprehend the nature of the study and to allow for the completion of all study assessments
  7. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study
  8. Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1
  9. Age of 6 years to 12 years at the time of entry into lead in study MEM-MD-91

Exclusion Criteria:

  1. Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
  2. Significant risk of suicidality based on the Investigator's judgment, the Aberrant Behavior Checklist-Irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior.
  3. Patients with evidence or history of malignancy (other than excised basal cell carcinoma) or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease
  4. Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception
  5. Patients requiring treatment with prohibited concomitant medications
  6. Patients who, in the opinion of the Investigator, might not be suitable for the study
  7. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center

Sites / Locations

  • Forest Investigative Site 068
  • Forest Investigative Site 005
  • Forest Investigative Site 055
  • Forest Investigative Site 077
  • Forest Investigative Site 054
  • Forest Investigative Site 109
  • Forest Investigative Site 096
  • Forest Investigative Site 021
  • Forest Investigative Site 026
  • Forest Investigative Site 002
  • Forest Investigative Site 078
  • Forest Investigative Site 073
  • Forest Investigative Site 052
  • Forest Investigative Site 075
  • Forest Investigative Site 080
  • Forest Investigative Site 117
  • Forest Investigative Site 065
  • Forest Investigative Site 118
  • Forest Investigative Site 085
  • Forest Investigative Site 115
  • Forest Investigative Site 125
  • Forest Investigative Site 062
  • Forest Investigative Site 067
  • Forest Investigative Site 101
  • Forest Investigative Site 102
  • Forest Investigative Site 023
  • Forest Investigative Site 082
  • Forest Investigative Site 056
  • Forest Investigative Site 106
  • Forest Investigative Site 061
  • Forest Investigative Site 095
  • Forest Investigative Site 086
  • Forest Investigative Site 059
  • Forest Investigative Site 108
  • Forest Investigative Site 116
  • Forest Investigative Site 097
  • Forest Investigative Site 130
  • Forest Investigative Site 104
  • Forest Investigative Site 136
  • Forest Investigative Site 127
  • Forest Investigative Site 081
  • Forest Investigative Site 107
  • Forest Investigative Site 072
  • Forest Investigative Site 069
  • Forest Investigative Site 001
  • Forest Investigative Site 019
  • Forest Investigative Site 092
  • Forest Investigative Site 053
  • Forest Investigative Site 132
  • Forest Investigative Site 131
  • Forest Investigative Site 100
  • Forest Investigative Site 105
  • Forest Investigative Site 090
  • Forest Investigative Site 057
  • Forest Investigative Site 051
  • Forest Investigative Site 070
  • Forest Investigative Site 028
  • Forest Investigative Site 141
  • Forest Investigative Site 029
  • Forest Investigative Site 064
  • Forest Investigative Site 113
  • Forest Investigative Site 071
  • Forest Investigative Site 119
  • Forest Investigative Site 063
  • Forest Investigative Site 204
  • Forest Investigative Site 203
  • Forest Investigative Site 228
  • Forest Investigative Site 226
  • Forest Investigative Site 276
  • Forest Investigative Site 329
  • Forest Investigative Site 381
  • Forest Investigative Site 376
  • Forest Investigative Site 378
  • Forest Investigative Site 401
  • Forest Investigative Site 453
  • Forest Investigative Site 452
  • Forest Investigative Site 704
  • Forest Investigative Site 702
  • Forest Investigative Site 703
  • Forest Investigative Site 701
  • Forest Investigative Site 526
  • Forest Investigative Site 579
  • Forest Investigative Site 578
  • Forest Investigative Site 576
  • Forest Investigative Site 577
  • Forest Investigative Site 626
  • Forest Investigative Site 627
  • Forest Investigative Site 629
  • Forest Investigative Site 628
  • Forest Investigative Site 676
  • Forest Investigative Site 728
  • Forest Investigative Site 807
  • Forest Investigative Site 802
  • Forest Investigative Site 804

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Memantine 1

Memantine 2

Placebo

Arm Description

Patients randomized to the full dose arm will continue taking memantine at the same tolerability and weight-based dose achieved in lead-in Study MEM-MD-91. Dosing will be once daily for up to 12 weeks.

Patients randomized to the reduced dose arm will take memantine at the tolerability and weight based dose that they received in lead in Study MEM-MD-91 reduced by at least 50%. Dosing will be once daily for up to 12 weeks.

Dosing will be once daily for up to 12 weeks.

Outcomes

Primary Outcome Measures

Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases)
Loss of Therapeutic response is defined as a worsening (increase) of at least 10 points in Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 (randomization) score. The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment with total raw score 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 Outcome Measures

Time to First Loss of Therapeutic (LTR) Response
Time to the first visit when a patient shows LTR following randomization to memantine or placebo.
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Context Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Interests Subscale at Week 12
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).

Full Information

First Posted
May 3, 2012
Last Updated
April 23, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01592747
Brief Title
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
Official Title
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
Detailed Description
This clinical study was a 12-week, multicenter, double-blind, placebo-controlled, randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). Patients who completed at least 12 weeks of study drug exposure and met protocol specified responder criterion in lead in Study MEM-MD-91 (NCT01592786) at two consecutive visits separated by at least two weeks were eligible to transition to this study. The responder criterion was defined as having at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score in Study MEM-MD-91. Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the NOAEL(No observed adverse effect level) of 15 mg/kg/day in juvenile rats. The weight-based dose limits in this study were as follows: Group A: ≥ 60 kg; maximum 15 mg/day Group B: 40-59 kg; maximum 9 mg/day Group C: 20-39 kg; maximum 6 mg/day Group D: < 20 kg; maximum 3 mg/day

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome, Autism Spectrum Disorders, Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
Keywords
Asperger's, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Memantine, Pediatric Disorder, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
479 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine 1
Arm Type
Experimental
Arm Description
Patients randomized to the full dose arm will continue taking memantine at the same tolerability and weight-based dose achieved in lead-in Study MEM-MD-91. Dosing will be once daily for up to 12 weeks.
Arm Title
Memantine 2
Arm Type
Experimental
Arm Description
Patients randomized to the reduced dose arm will take memantine at the tolerability and weight based dose that they received in lead in Study MEM-MD-91 reduced by at least 50%. Dosing will be once daily for up to 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dosing will be once daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Memantine Hydrochloride (HCl)
Intervention Description
Extended Release Dose ranging from 3-15mg/day; administered orally
Intervention Type
Drug
Intervention Name(s)
Memantine Hydrochloride (HCl)
Intervention Description
Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Intervention Description
Once daily, oral administration.
Primary Outcome Measure Information:
Title
Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases)
Description
Loss of Therapeutic response is defined as a worsening (increase) of at least 10 points in Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 (randomization) score. The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment with total raw score 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.
Time Frame
Baseline (Visit 1) to week 12
Secondary Outcome Measure Information:
Title
Time to First Loss of Therapeutic (LTR) Response
Description
Time to the first visit when a patient shows LTR following randomization to memantine or placebo.
Time Frame
Baseline to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Context Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12
Title
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Interests Subscale at Week 12
Description
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Time Frame
Baseline (Visit 1) to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 (NCT01592786) Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91 Provide written informed assent, when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. The parent/guardian/LAR must provide written informed consent before the patient's participation in the study. A separate written informed consent for the caregiver must also be obtained before the conduct of any study specific procedures Have a knowledgeable caregiver who is capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug. Every effort should be made to maintain the same caregiver as used in the lead-in study throughout this study Have normal results from the physical examination, laboratory tests, ECG, and vital signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings must be deemed not clinically significant by the Investigator and documented Be able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR who is able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), to comprehend the nature of the study and to allow for the completion of all study assessments Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1 Age of 6 years to 12 years at the time of entry into lead in study MEM-MD-91 Exclusion Criteria: Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being Significant risk of suicidality based on the Investigator's judgment, the Aberrant Behavior Checklist-Irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior. Patients with evidence or history of malignancy (other than excised basal cell carcinoma) or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception Patients requiring treatment with prohibited concomitant medications Patients who, in the opinion of the Investigator, might not be suitable for the study Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Lateiner, MS, MBA
Organizational Affiliation
Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 068
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Forest Investigative Site 005
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Forest Investigative Site 055
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Forest Investigative Site 077
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
Forest Investigative Site 054
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Forest Investigative Site 109
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Forest Investigative Site 096
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Forest Investigative Site 021
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0984
Country
United States
Facility Name
Forest Investigative Site 026
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Forest Investigative Site 002
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5719
Country
United States
Facility Name
Forest Investigative Site 078
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Forest Investigative Site 073
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Forest Investigative Site 052
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Forest Investigative Site 075
City
Bradenton
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Forest Investigative Site 080
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 117
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site 065
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Forest Investigative Site 118
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Forest Investigative Site 085
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Forest Investigative Site 115
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Forest Investigative Site 125
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Forest Investigative Site 062
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 067
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Forest Investigative Site 101
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Forest Investigative Site 102
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Forest Investigative Site 023
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Forest Investigative Site 082
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Forest Investigative Site 056
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 106
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3199
Country
United States
Facility Name
Forest Investigative Site 061
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Forest Investigative Site 095
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Forest Investigative Site 086
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Forest Investigative Site 059
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Forest Investigative Site 108
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Forest Investigative Site 116
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Forest Investigative Site 097
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Forest Investigative Site 130
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Forest Investigative Site 104
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Forest Investigative Site 136
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Forest Investigative Site 127
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Forest Investigative Site 081
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5129
Country
United States
Facility Name
Forest Investigative Site 107
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Forest Investigative Site 072
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Forest Investigative Site 069
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
Forest Investigative Site 001
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Forest Investigative Site 019
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Forest Investigative Site 092
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Forest Investigative Site 053
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Forest Investigative Site 132
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States
Facility Name
Forest Investigative Site 131
City
McMurray
State/Province
Pennsylvania
ZIP/Postal Code
15317
Country
United States
Facility Name
Forest Investigative Site 100
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Forest Investigative Site 105
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Forest Investigative Site 090
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 057
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Forest Investigative Site 051
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Forest Investigative Site 070
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Forest Investigative Site 028
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Forest Investigative Site 141
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Forest Investigative Site 029
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Forest Investigative Site 064
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Forest Investigative Site 113
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Forest Investigative Site 071
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Forest Investigative Site 119
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Forest Investigative Site 063
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Forest Investigative Site 204
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Forest Investigative Site 203
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Forest Investigative Site 228
City
Bello
Country
Colombia
Facility Name
Forest Investigative Site 226
City
Bogotá
Country
Colombia
Facility Name
Forest Investigative Site 276
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Forest Investigative Site 329
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Forest Investigative Site 381
City
Budapest
ZIP/Postal Code
1026
Country
Hungary
Facility Name
Forest Investigative Site 376
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Forest Investigative Site 378
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Forest Investigative Site 401
City
Kopavogur
ZIP/Postal Code
200
Country
Iceland
Facility Name
Forest Investigative Site 453
City
Roma
ZIP/Postal Code
165
Country
Italy
Facility Name
Forest Investigative Site 452
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Forest Investigative Site 704
City
Yangsan-si
State/Province
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Forest Investigative Site 702
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Forest Investigative Site 703
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Forest Investigative Site 701
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Forest Investigative Site 526
City
Wellington
ZIP/Postal Code
6012
Country
New Zealand
Facility Name
Forest Investigative Site 579
City
Gdansk
ZIP/Postal Code
80-542
Country
Poland
Facility Name
Forest Investigative Site 578
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Forest Investigative Site 576
City
Kobierzyce
ZIP/Postal Code
55-040
Country
Poland
Facility Name
Forest Investigative Site 577
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Forest Investigative Site 626
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 627
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 629
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Forest Investigative Site 628
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Forest Investigative Site 676
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Forest Investigative Site 728
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Forest Investigative Site 807
City
Kharkiv
ZIP/Postal Code
61153
Country
Ukraine
Facility Name
Forest Investigative Site 802
City
Kherson,Vil. Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Forest Investigative Site 804
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
36006807
Citation
Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.
Results Reference
derived

Learn more about this trial

Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine

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