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Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

This study has been completed.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Forest Laboratories
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584948
First received: December 22, 2007
Last updated: May 24, 2017
Last verified: May 2017
  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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: December 22, 2007
Results First Received: June 27, 2014
Last Updated: May 24, 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

ClinicalTrials.gov processed this record on July 25, 2017