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Trial record 4 of 4 for:    fxtas

Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

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ClinicalTrials.gov Identifier: NCT00584948
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : April 10, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Forest Laboratories
Information provided by (Responsible Party):
University of California, Davis

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
Enrollment 94

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Memantine Placebo
Hide Arm/Group Description 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. 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
Period Title: Overall Study
Started 47 47
Completed 34 36
Not Completed 13 11
Arm/Group Title Memantine Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 47 47 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 47 participants 94 participants
64.7  (9.7) 66.3  (7.0) 65.5  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
Female
15
  31.9%
19
  40.4%
34
  36.2%
Male
32
  68.1%
28
  59.6%
60
  63.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 47 participants 94 participants
47 47 94
1.Primary Outcome
Title Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)
Hide Description The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance.
Time Frame One Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine Placebo
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 34 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17.44  (5.19) 16.12  (5.43)
One Year 15.66  (4.11) 15.72  (3.93)
2.Primary Outcome
Title Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale
Hide Description The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine Placebo
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 34 36
Mean (Standard Deviation)
Unit of Measure: m/s^2
Baseline 1.31  (1.02) 1.05  (0.73)
One Year 1.77  (1.78) 1.89  (2.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memantine Placebo
Hide Arm/Group Description 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. 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
All-Cause Mortality
Memantine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Memantine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/47 (4.26%)      3/47 (6.38%)    
Gastrointestinal disorders     
Appendicitis * [1]  0/47 (0.00%)  0 1/47 (2.13%)  1
Musculoskeletal and connective tissue disorders     
Motor Vehicle Accident * [2]  1/47 (2.13%)  1 0/47 (0.00%)  0
Reproductive system and breast disorders     
Ovarian Cancer * [3]  0/47 (0.00%)  0 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders     
Lung Cancer * [4]  1/47 (2.13%)  1 0/47 (0.00%)  0
Pneumonia * [5]  0/47 (0.00%)  0 1/47 (2.13%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One participant had acute appendicitis and required an appendectomy, and withdrew from the study
[2]
One participant was badly injured in a motor vehicle accident and withdrew from the study
[3]
One participant was diagnosed with ovarian cancer and withdrew from the study
[4]
One participant was diagnosed with terminal lung cancer and withdrew from the study
[5]
One participant was diagnosed with pneumonia and withdrew from the study
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Memantine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/47 (12.77%)      2/47 (4.26%)    
Gastrointestinal disorders     
Constipation *  6/47 (12.77%)  10 2/47 (4.26%)  4
*
Indicates events were collected by non-systematic assessment
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
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