Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury

This study has been terminated.
(The study was stopped due to a lack of additional subjects.)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Jon Rupright, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00462228
First received: April 10, 2007
Last updated: October 24, 2013
Last verified: October 2013
Results First Received: May 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Traumatic Brain Injury
Interventions: Drug: memantine
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited by contacting patients of the principal investigator (PI) when they presented for regularly scheduled clinic appointments or by referrals from colleagues. The recruitment period was from was from July 2007 through December 2010.

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
Overall Study All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design. Five subjects were randomized to begin the study by taking memantine and crossover to placebo; seven subjects began with placebo and crossed over to memantine.

Participant Flow for 4 periods

Period 1:   Memantine or Placebo 12 Weeks
    Overall Study  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  

Period 2:   No Treatment (Washout) 4 Weeks
    Overall Study  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  

Period 3:   Placebo or Memantine 12 Weeks
    Overall Study  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  

Period 4:   No Treatment (Washout) 4 Weeks
    Overall Study  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Overall Study All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.6  ± 8.1  
Gender  
[units: participants]
 
Female     2  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Learning Scores.   [ Time Frame: Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo ]

2.  Primary:   Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Delayed Recall Scores.   [ Time Frame: Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo ]

3.  Primary:   Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Total Recall Score.   [ Time Frame: Baseline, 6 weeks, 12 weeks after beginning Namenda or placebo ]

4.  Primary:   Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Delayed Recall Score.   [ Time Frame: Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo ]

5.  Secondary:   Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part A.   [ Time Frame: baseline, 6 weeks, 12 weeks ]

6.  Secondary:   Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part B.   [ Time Frame: Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo ]

7.  Secondary:   Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT)Written Score.   [ Time Frame: baseline, 6 weeks, 12 weeks ]

8.  Secondary:   Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT) Oral Score.   [ Time Frame: Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The enrollment goal for the study was 20 subjects. The study included 11 subjects but was terminated due to a lack of additional subjects.


  More Information
  Hide More Information

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: Dr. S. Jon Rupright
Organization: Department of Physical Medicine and Rehabilitation, University of Missouri
phone: 573-882-3101
e-mail: RuprightJ@health.missouri.edu


No publications provided


Responsible Party: Jon Rupright, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00462228     History of Changes
Other Study ID Numbers: NAM-MD-44
Study First Received: April 10, 2007
Results First Received: May 18, 2012
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board