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Does Memantine Improve Verbal Memory Task Performance in Subjects With Partial Epilepsy and Memory Dysfunction?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054599
First Posted: January 22, 2010
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Beth Leeman, M.D., Massachusetts General Hospital
Results First Submitted: March 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: Memantine
Other: Sugar Pill

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Memantine

Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.

Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.

Sugar Pill

Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.

Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study


Participant Flow:   Overall Study
    Memantine   Sugar Pill
STARTED   13   16 
COMPLETED   9   9 
NOT COMPLETED   4   7 
Dizziness due to phenytoin toxicity                1                0 
Protocol Violation                1                0 
Spells/seizure-like episodes                1                1 
Timing/scheduling difficulties                1                1 
Visual impairment, WTAR <80                0                1 
Lost to Follow-up                0                2 
Adverse Event                0                1 
Withdrawal by Subject                0                1 



  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.
No text entered.

Reporting Groups
  Description
Memantine

Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.

Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.

Sugar Pill

Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.

Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study

Total Total of all reporting groups

Baseline Measures
   Memantine   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   16   29 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.7  (13.1)   45.3  (12.6)   44.6  (12.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  30.8%      6  37.5%      10  34.5% 
Male      9  69.2%      10  62.5%      19  65.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity       
White/Caucasian      11  84.6%      16 100.0%      27  93.1% 
Black or African American      1   7.7%      0   0.0%      1   3.4% 
Hispanic or Latino      1   7.7%      0   0.0%      1   3.4% 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Other      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
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1.  Primary:   The Change Scores in Memory Measures From Baseline to Post-treatment/Placebo Will be Compared Between the Memantine Treatment and Placebo Groups.   [ Time Frame: 13 weeks ]

2.  Secondary:   A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.   [ Time Frame: 26 weeks ]

3.  Secondary:   To Test the Hypothesis That Improvement Will be Selective for Verbal Memory, Change Scores on the Non-verbal Tasks Will be Compared Between the Placebo and Memantine Treatment Groups.   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

4.  Secondary:   To Test the Hypothesis That Treatment With Memantine Will Result in Subjective Improvement of Memory Function, the Change Scores From the QOLIE-89 Will be Evaluated.   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  


  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 NOT 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.


Results Point of Contact:  
Name/Title: Beth Leeman-Markowski, MD
Organization: VA New York Harbor Healthcare System, NYU
phone: 212-686-7500
e-mail: beth.leeman-markowski@nyumc.org


Publications:


Responsible Party: Beth Leeman, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01054599     History of Changes
Other Study ID Numbers: 2008P000107
First Submitted: December 1, 2009
First Posted: January 22, 2010
Results First Submitted: March 23, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017