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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01592747
Other study ID # MEM-MD-68
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2012
Est. completion date October 2013

Study information

Verified date March 2019
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Completed
Enrollment 479
Est. completion date October 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Memantine Hydrochloride (HCl)
Extended Release Dose ranging from 3-15mg/day; administered orally
Memantine Hydrochloride (HCl)
Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.
Placebo capsules
Once daily, oral administration.

Locations

Country Name City State
Belgium Forest Investigative Site 204 Brussel
Belgium Forest Investigative Site 203 Bruxelles
Colombia Forest Investigative Site 228 Bello
Colombia Forest Investigative Site 226 Bogotá
Estonia Forest Investigative Site 276 Tallinn
France Forest Investigative Site 329 Bron Cedex
Hungary Forest Investigative Site 376 Budapest
Hungary Forest Investigative Site 378 Budapest
Hungary Forest Investigative Site 381 Budapest
Iceland Forest Investigative Site 401 Kopavogur
Italy Forest Investigative Site 453 Roma
Italy Forest Investigative Site 452 Siena
Korea, Republic of Forest Investigative Site 701 Seoul
Korea, Republic of Forest Investigative Site 702 Seoul
Korea, Republic of Forest Investigative Site 703 Seoul
Korea, Republic of Forest Investigative Site 704 Yangsan-si Gyeongsangnam-do
New Zealand Forest Investigative Site 526 Wellington
Poland Forest Investigative Site 578 Gdansk
Poland Forest Investigative Site 579 Gdansk
Poland Forest Investigative Site 576 Kobierzyce
Poland Forest Investigative Site 577 Warszawa
Serbia Forest Investigative Site 626 Belgrade
Serbia Forest Investigative Site 627 Belgrade
Serbia Forest Investigative Site 629 Nis
Serbia Forest Investigative Site 628 Novi Sad
South Africa Forest Investigative Site 676 Cape Town Western Cape
Spain Forest Investigative Site 728 Sabadell Barcelona
Ukraine Forest Investigative Site 807 Kharkiv
Ukraine Forest Investigative Site 802 Kherson,Vil. Stepanivka
Ukraine Forest Investigative Site 804 Kyiv
United States Forest Investigative Site 081 Albuquerque New Mexico
United States Forest Investigative Site 107 Albuquerque New Mexico
United States Forest Investigative Site 069 Avon Lake Ohio
United States Forest Investigative Site 071 Bothell Washington
United States Forest Investigative Site 078 Boulder Colorado
United States Forest Investigative Site 075 Bradenton Florida
United States Forest Investigative Site 073 Centennial Colorado
United States Forest Investigative Site 072 Chapel Hill North Carolina
United States Forest Investigative Site 105 Charleston South Carolina
United States Forest Investigative Site 119 Charleston West Virginia
United States Forest Investigative Site 064 Charlottesville Virginia
United States Forest Investigative Site 028 Clinton Utah
United States Forest Investigative Site 001 Columbus Ohio
United States Forest Investigative Site 068 Dothan Alabama
United States Forest Investigative Site 082 Evansville Indiana
United States Forest Investigative Site 080 Gainesville Florida
United States Forest Investigative Site 054 Glendale California
United States Forest Investigative Site 053 Gresham Oregon
United States Forest Investigative Site 130 Henderson Nevada
United States Forest Investigative Site 051 Houston Texas
United States Forest Investigative Site 109 Imperial California
United States Forest Investigative Site 056 Indianapolis Indiana
United States Forest Investigative Site 117 Jacksonville Florida
United States Forest Investigative Site 132 Johnstown Pennsylvania
United States Forest Investigative Site 095 Lake Charles Louisiana
United States Forest Investigative Site 104 Las Vegas Nevada
United States Forest Investigative Site 102 Libertyville Illinois
United States Forest Investigative Site 097 Lincoln Nebraska
United States Forest Investigative Site 116 Lincoln Nebraska
United States Forest Investigative Site 077 Little Rock Arkansas
United States Forest Investigative Site 096 Los Angeles California
United States Forest Investigative Site 061 Louisville Kentucky
United States Forest Investigative Site 065 Maitland Florida
United States Forest Investigative Site 131 McMurray Pennsylvania
United States Forest Investigative Site 100 Media Pennsylvania
United States Forest Investigative Site 090 Memphis Tennessee
United States Forest Investigative Site 118 Miami Florida
United States Forest Investigative Site 063 Middleton Wisconsin
United States Forest Investigative Site 023 Naperville Illinois
United States Forest Investigative Site 057 Nashville Tennessee
United States Forest Investigative Site 136 Neptune New Jersey
United States Forest Investigative Site 059 Newton Massachusetts
United States Forest Investigative Site 113 Norfolk Virginia
United States Forest Investigative Site 085 Oakland Park Florida
United States Forest Investigative Site 141 Ogden Utah
United States Forest Investigative Site 019 Oklahoma City Oklahoma
United States Forest Investigative Site 115 Orange City Florida
United States Forest Investigative Site 062 Orlando Florida
United States Forest Investigative Site 125 Orlando Florida
United States Forest Investigative Site 005 Phoenix Arizona
United States Forest Investigative Site 086 Rockville Maryland
United States Forest Investigative Site 029 Salt Lake City Utah
United States Forest Investigative Site 021 San Francisco California
United States Forest Investigative Site 026 Santa Ana California
United States Forest Investigative Site 108 Springfield Massachusetts
United States Forest Investigative Site 002 Stanford California
United States Forest Investigative Site 067 Tampa Florida
United States Forest Investigative Site 070 The Woodlands Texas
United States Forest Investigative Site 127 Toms River New Jersey
United States Forest Investigative Site 055 Tucson Arizona
United States Forest Investigative Site 092 Tulsa Oklahoma
United States Forest Investigative Site 052 Washington District of Columbia
United States Forest Investigative Site 101 Wellington Florida
United States Forest Investigative Site 106 Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Belgium,  Colombia,  Estonia,  France,  Hungary,  Iceland,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Serbia,  South Africa,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (Visit 1) to week 12
Secondary Time to First Loss of Therapeutic (LTR) Response Time to the first visit when a patient shows LTR following randomization to memantine or placebo. Baseline to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
Secondary 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). Baseline (Visit 1) to week 12
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