Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

This study is currently recruiting participants.

Verified by University of California, Davis, December 2007

Sponsors and Collaborators:	University of California, Davis National Institute on Aging (NIA) Forest Laboratories
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00584948

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

Genetics Home Reference related topics: Friedreich ataxia

MedlinePlus related topics: Tremor

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine

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:

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 79 Years
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

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	Not yet recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Maureen Leehey, MD

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

Responsible Party:	University of California, Davis ( Randi J. Hagerman, M.D. )
Study ID Numbers:	200715426-1, 1 RL1 AG032115-01
Study First Received:	December 22, 2007
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00584948
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

Study placed in the following topic categories:

Excitatory Amino Acids
Signs and Symptoms
Dopamine
Ataxia
Memantine

Neurologic Manifestations
Congenital Abnormalities
Dyskinesias
Tremor

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents

Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Syndrome
Dopamine Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009