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; Drug: Memantine

• 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

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-22
• Study First Submitted QC: 2007-12-22
• Study First Posted: 2008-01-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2014-06-27
• Results First Submitted QC: 2017-02-22
• Results First Posted: 2017-04-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

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

Group	Intervention	Description
Placebo	Placebo	-
Memantine	Memantine	-

Primary Outcome Measures

Name	Time	Method
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 Scale	1 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

Trial Locations

Locations (2)

UC Davis MIND Institute; 🇺🇸 Sacramento, California, United States

University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States