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Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism

This study has been completed.
Sponsor:
Collaborator:
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00872898
First received: March 30, 2009
Last updated: November 26, 2013
Last verified: November 2013
Results First Received: August 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Autism
Interventions: Drug: Memantine - Extended Release (ER)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients for Part One of the study were recruited during a 15 month period from April of 2009, to June of 2010. Patients for Part Two of the study were recruited for a 37 month period from April of 2009 to April of 2012. All study sites were located in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part One of the study enrolled 4 patients to determine a safe dosing regimen for Part Two. One patient from Part One of the study also enrolled in Part Two. The 121 patients enrolled in Part Two were randomized after two weeks of single-blind placebo treatment.

Reporting Groups
  Description
Placebo Once daily, oral administration of placebo for 12 weeks.
Memantine

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.


Participant Flow for 2 periods

Period 1:   Part One - Open Label, Pharmacokinetics
    Placebo     Memantine  
STARTED     0     4  
COMPLETED     0     4  
NOT COMPLETED     0     0  

Period 2:   Part Two - Double Blind
    Placebo     Memantine  
STARTED     61     60  
COMPLETED     50     54  
NOT COMPLETED     11     6  
Adverse Event                 4                 3  
Lack of Efficacy                 1                 0  
Protocol Violation                 1                 0  
Withdrawal by Subject                 3                 1  
Lost to Follow-up                 0                 2  
Other reasons                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Part One of the study enrolled 4 patients to determine a safe dosing regimen for Part Two along with data collected for 14 patients enrolled in study MEM-PK-21. One patient from Part One of the study also enrolled in Part Two. The 121 patients enrolled in Part Two were randomized after two weeks of single-blind placebo treatment.

Reporting Groups
  Description
Part One - Memantine Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
Part Two - Placebo Once daily oral administration of placebo for 12 weeks.
Part Two - 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.
Total Total of all reporting groups

Baseline Measures
    Part One - Memantine     Part Two - Placebo     Part Two - Memantine     Total  
Number of Participants  
[units: participants]
  3     61     60     124  
Age  
[units: years]
Mean ± Standard Deviation
       
6 years to 18 years     9.0  ± 2.6     8.9  ± 2.2     9.0  ± 2.2     9.0  ± 0.1  
Age, Customized  
[units: participants]
       
6 years to 12 years     3     60     59     122  
13 years to 18 years     0     1     1     2  
Gender  
[units: participants]
       
Female     2     12     8     22  
Male     1     49     52     102  
Region of Enrollment  
[units: participants]
       
United States     3     61     60     124  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Extent of Absorption of Memantine (Part One)   [ Time Frame: Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose ]

2.  Primary:   Change in Total Raw Score of Social Responsiveness Scale   [ Time Frame: From Baseline to Week 12 ]

3.  Secondary:   Core Autism Treatment Scale-Improvement: Total Score   [ Time Frame: At Week 12 ]

4.  Secondary:   Core Autism Treatment Scale-Improvement: Social Interaction   [ Time Frame: At Week 12 ]

5.  Secondary:   Core Autism Treatment Scale-Improvement: Communication   [ Time Frame: At Week 12 ]

6.  Secondary:   Change in Children’s Communication Checklist-2 (CCC-2) - Speech Subscale   [ Time Frame: From Baseline to Week 12 ]

7.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale   [ Time Frame: From Baseline to Week 12 ]

8.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale   [ Time Frame: From Baseline to Week 12 ]

9.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale   [ Time Frame: From Baseline to Week 12 ]

10.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale   [ Time Frame: From Baseline to Week 12 ]

11.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale   [ Time Frame: From Baseline to Week 12 ]

12.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale   [ Time Frame: From Baseline to Week 12 ]

13.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale   [ Time Frame: From Baseline to Week 12 ]

14.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale   [ Time Frame: From Baseline to Week 12 ]

15.  Secondary:   Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale   [ Time Frame: From Baseline to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ephraim Katz, PhD / Associate Director
Organization: Forest Research Institute
phone: 201-427-8000 ext 8169
e-mail: Ephraim.Katz@frx.com


No publications provided


Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00872898     History of Changes
Other Study ID Numbers: MEM-MD-57A
Study First Received: March 30, 2009
Results First Received: August 1, 2013
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration