Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

• ClinicalTrials.gov Identifier: NCT00584948
• Recruitment Status: Completed
• First Posted: January 2, 2008
• Results First Posted: April 10, 2017
• Last Update Posted: May 30, 2017
• Sponsor: University of California, Davis
• Collaborators: National Institute on Aging (NIA); Forest Laboratories
• Information provided by (Responsible Party): University of California, Davis

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Fragile X-Associated Tremor/Ataxia Syndrome; Fragile X Premutation Carriers	Drug: Memantine; Drug: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• 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
• Study Start Date: September 2007
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: September 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• 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

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):

Seritan AL, Nguyen DV, Mu Y, Tassone F, Bourgeois JA, Schneider A, Cogswell JB, Cook KR, Leehey MA, Grigsby J, Olichney JM, Adams PE, Legg W, Zhang L, Hagerman PJ, Hagerman RJ. Memantine for fragile X-associated tremor/ataxia syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Mar;75(3):264-71. doi: 10.4088/JCP.13m08546.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT00584948
• Other Study ID Numbers: 200715426-1; 1RL1AG032115-01 ( U.S. NIH Grant/Contract )
• First Posted: January 2, 2008
• 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:

Ataxia; Tremor; Syndrome; Disease; Pathologic Processes; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; 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