Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Forest Laboratories
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584948
First received: December 22, 2007
Last updated: June 25, 2010
Last verified: June 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Improvement in neurocognitive functioning [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in Cognitive ERP Deficits [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms

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

Contacts
Contact: Jennifer B Cogswell 916-703-0331 jennifer.cogswell@ucdmc.ucdavis.edu
Contact: Louise Gane 916-703-0238 louise.gane@ucdmc.ucdavis.edu

Locations
United States, California
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Contact: Jennifer B Cogswell    916-703-0331    jennifer.cogswell@ucdmc.ucdavis.edu   
Contact: Louise Gane    916-703-0238    louise.gane@ucdmc.ucdavis.edu   
Principal Investigator: Randi J Hagerman, MD         
United States, Colorado
University of Colorado Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Maureen Leehey, MD         
Sponsors and Collaborators
University of California, Davis
Forest Laboratories
Investigators
Principal Investigator: Randi J Hagerman, MD University of California, Davis
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Randi J. Hagerman, M.D., University of California, Davis
ClinicalTrials.gov Identifier: NCT00584948     History of Changes
Other Study ID Numbers: 200715426-1, 1 RL1 AG032115-01
Study First Received: December 22, 2007
Last Updated: June 25, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tremor
Syndrome
Ataxia
Fragile X Syndrome
Cerebellar Diseases
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Brain Diseases
Central Nervous System Diseases
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014