Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

Fragile X-Associated Tremor/Ataxia Syndrome Clinical Trial

Official title:

Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584948
• Other study ID #: 200715426-1
• Secondary ID: 1RL1AG032115-01
• Status: Completed
• Phase: N/A
• First received: December 22, 2007
• Last updated: May 24, 2017
• Start date: September 2007
• Est. completion date: September 2012

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5

Exclusion Criteria:

• Previous reaction to memantine

Related Conditions & MeSH terms

• Ataxia
• Fragile X Premutation Carriers
• Fragile X-Associated Tremor/Ataxia Syndrome
• Syndrome
• Tremor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	UC Davis MIND Institute	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Forest Laboratories, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)	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.	One Year
Primary	Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale	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	1 year