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Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584948
First Posted: January 2, 2008
Last Update Posted: May 30, 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.
Collaborators:
National Institute on Aging (NIA)
Forest Laboratories
Information provided by (Responsible Party):
University of California, Davis
Results First Submitted: June 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Fragile X-Associated Tremor/Ataxia Syndrome
Fragile X Premutation Carriers
Interventions: Drug: Memantine
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Memantine Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
Placebo Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study

Participant Flow:   Overall Study
    Memantine   Placebo
STARTED   47   47 
COMPLETED   34   36 
NOT COMPLETED   13   11 



  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 Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
Placebo Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
Total Total of all reporting groups

Baseline Measures
   Memantine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   47   94 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (9.7)   66.3  (7.0)   65.5  (8.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  31.9%      19  40.4%      34  36.2% 
Male      32  68.1%      28  59.6%      60  63.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
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% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      47 100.0%      47 100.0%      94 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   2.1%      4   8.5%      5   5.3% 
Not Hispanic or Latino      46  97.9%      43  91.5%      89  94.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   47   47   94 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)   [ Time Frame: One Year ]

2.  Primary:   Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale   [ Time Frame: 1 year ]


  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: Randi J Hagerman, MD
Organization: University of California, Davis Medical Center
phone: 916-703-0247
e-mail: randi.hagerman@ucdmc.ucdavis.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00584948     History of Changes
Other Study ID Numbers: 200715426-1
1RL1AG032115-01 ( U.S. NIH Grant/Contract )
First Submitted: December 22, 2007
First Posted: January 2, 2008
Results First Submitted: June 27, 2014
Results First Posted: April 10, 2017
Last Update Posted: May 30, 2017