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Trial record 1 of 1 for:    00584948
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Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584948
First Posted: January 2, 2008
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Aging (NIA)
Forest Laboratories
Information provided by (Responsible Party):
University of California, Davis
  Purpose
The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.

Condition Intervention
Fragile X-Associated Tremor/Ataxia Syndrome Fragile X Premutation Carriers Drug: Memantine Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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.

  • 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


Enrollment: 94
Study Start Date: September 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine 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.
Other Name: Namenda
Placebo Comparator: Placebo Drug: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous reaction to memantine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584948


Locations
United States, California
UC Davis MIND Institute
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of California, Davis
National Institute on Aging (NIA)
Forest Laboratories
Investigators
Principal Investigator: Randi J Hagerman, MD University of California, Davis
  More Information

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
Last Verified: May 2017

Keywords provided by University of California, Davis:
FXTAS, Fragile X Premutation

Additional relevant MeSH terms:
Syndrome
Ataxia
Tremor
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents