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OpenTrials
Completed

NCT Number: NCT00584948

Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

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

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Key information

Conditions

Fragile X-associated Tremor/Ataxia Syndrome Fragile X Premutation Carriers Fragile X Tremor Ataxia Syndrome

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis MIND Institute, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous reaction to memantine

Treatment and study plan

Memantine

Drug

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.

Other names: Namenda

Placebo

Drug

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.

Primary outcomes

  1. Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)

    Time frame: 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.

  2. Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Forest Laboratories
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jan 2, 2008
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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