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Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

Not Applicable
Completed
Conditions
Fragile X-Associated Tremor/Ataxia Syndrome
Fragile X Premutation Carriers
Interventions
Drug: Placebo
Registration Number
NCT00584948
Lead Sponsor
University of California, Davis
Brief Summary

The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
94
Inclusion Criteria
  • Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5
Exclusion Criteria
  • Previous reaction to memantine

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
MemantineMemantine-
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)One Year

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.

Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale1 year

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

UC Davis MIND Institute

🇺🇸

Sacramento, California, United States

University of Colorado Health Sciences Center

🇺🇸

Aurora, Colorado, United States

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